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1993 Sexually Transmitted Diseases Treatment Guidelines
09/24/1993 SUGGESTED CITATION Centers for Disease Control and Prevention. 1993 Sexually transmitted diseases treatment guidelines. MMWR 1993;42(No. RR-14): {inclusive page numbers}. CIO Responsible for this publication: National Center for Prevention Services, Division of Sexually Transmitted Diseases and HIV Prevention DISEASES CHARACTERIZED BY URETHRITIS AND CERVICITIS Management of the Patient with Urethritis Urethritis, or inflammation of the urethra, is caused by an infection characterized by the discharge of mucoid or purulent material and by burning during urination. However, asymptomatic infections are common. The two bacterial agents primarily responsible for urethritis among men are N. gonorrhoeae and C. trachomatis. Testing to determine the specific diagnosis is recommended because both of these infections are reportable to state health departments and because with a specific diagnosis, treatment compliance may be better and the likelihood of partner notification may be improved. If diagnostic tools (e.g., Gram stain and microscope) are unavailable, health-care providers should treat patients for both infections. The added expense of treating a person with nongonococcal urethritis (NGU) for both infections also should encourage the health-care provider to make a specific diagnosis. (See Nongonococcal Urethritis, Chlamydial Infections, and Gonococcal Infections.) Nongonococcal Urethritis NGU, or inflammation of the urethra not caused by gonococcal infection, is characterized by a mucoid or purulent urethral discharge. In the presence or absence of a discharge, NGU may be diagnosed by greater than or equal to 5 polymorphonuclear leukocytes per oil immersion field on a smear of an intraurethral swab specimen. Increasingly, the leukocyte esterase test (LET) is being used to screen urine from asymptomatic males for evidence of urethritis (either gonococcal or nongonococcal). The diagnosis of urethritis among males tested with LET should be confirmed with a Gram-stained smear of a urethral swab specimen. C. trachomatis is the most frequent cause of NGU (23%-55% of cases); however, prevalence varies among age groups, with lower prevalence found among older men. Ureaplasma urealyticum causes 20%-40% of cases, and Trichomonas vaginalis 2%-5%. HSV is occasionally responsible for cases of NGU. The etiology of the remaining cases of NGU is unknown. Complications of NGU among men infected with C. trachomatis include epididymitis and Reiter's syndrome. Female sex partners of men who have NGU are at risk for chlamydial infection and associated complications. Recommended Regimen - Doxycycline 100 mg orally 2 times a day for 7 days. * Alternative Regimens - Erythromycin base 500 mg orally 4 times a day for 7 days or Erythromycin ethylsuccinate 800 mg orally 4 times a day for 7 days. If a patient cannot tolerate high-dose erythromycin schedules, one of the following regimens may be used: Erythromycin base 250 mg orally 4 times a day for 14 days or Erythromycin ethylsuccinate 400 mg orally 4 times a day for 14 days. Treatment with the recommended regimen has been demonstrated in most cases to result in alleviation of symptoms and in microbiologic cure of infection. If the etiologic organism is susceptible to the antimicrobial agent used, sequelae specific to that organism will be prevented, as will further transmission; this is especially important for cases of NGU caused by C. trachomatis. Follow-Up Patients should be instructed to return for evaluation if symptoms persist or recur after completion of therapy. Patients with persistent or recurrent urethritis should be re-treated with the initial regimen if they failed to comply with the treatment regimen or if they were re-exposed to an untreated sex partner. Otherwise, a wet mount examination and culture of an intraurethral swab specimen for T. vaginalis should be performed; if negative, the patient should be retreated with an alternative regimen extended to 14 days (e.g., erythromycin base 500 mg orally 4 times a day for 14 days). The use of alternative regimens ensures treatment of possible tetracycline-resistant U. urealyticum. Effective regimens have not been identified for treating patients who experience persistent symptoms or frequent recurrences following treatment with doxycycline and erythromycin. Urologic examinations do not usually reveal a specific etiology. Such patients should be assured that, although they have persistent or frequently recurring urethritis, the condition is not known to cause complications among them or their sex partners and is not known to be sexually transmitted. However, men exposed to a new sex partner should be re-evaluated. Symptoms alone, without documentation of signs or laboratory evidence of urethral inflammation, are not a sufficient basis for re-treatment. Management of Sex Partners Patients should be instructed to refer sex partners for evaluation and treatment. Since exposure intervals have received limited evaluation, the following recommendations are somewhat arbitrary. Sex partners of symptomatic patients should be evaluated and treated if their last sexual contact with the index patient was within 30 days of onset of symptoms. If the index patient is asymptomatic, sex partners whose last sexual contact with the index patient was within 60 days of diagnosis should be evaluated and treated. If the patient's last sexual intercourse preceded the time intervals previously described, the most recent sex partner should be treated. A specific diagnosis may facilitate partner referral and partner cooperation. Therefore, testing for both gonorrhea and chlamydia is encouraged. Patients should be instructed to abstain from sexual intercourse until patient and partners are cured. In the absence of microbiologic test-of-cure, this means when therapy is completed and patient and partners are without symptoms or signs. Special Considerations HIV Infection - Persons with HIV infection and NGU should receive the same treatment as patients without HIV infection. * Azithromycin 1 g in a single dose, according to manufacturer's data, is equivalent to doxycycline. However, this study has not been published in a peer-reviewed journal. For a discussion comparing azithromycin and doxycyline, refer to Chlamydial Infections. Management of the Patient With Mucopurulent Cervicitis Mucopurulent cervicitis (MPC) is characterized by a yellow endocervical exudate visible in the endocervical canal or in an endocervical swab specimen. Some experts also make the diagnosis on the basis of an increased number of polymorphonuclear leukocytes on cervical Gram stain. The condition is asymptomatic among many women, but some may experience an abnormal vaginal discharge and abnormal vaginal bleeding (e.g., following intercourse). The condition can be caused by C. trachomatis or N. gonorrhoeae, although in most cases neither organism can be isolated. Patients with MPC should have cervical specimens tested for C. trachomatis and cultured for N. gonorrhoeae. MPC is not a sensitive predictor of infection; however, most women with C. trachomatis or N. gonorrhoeae do not have MPC. Treatment The results of tests for C. trachomatis or N. gonorrhoeae should determine the need for treatment, unless the likelihood of infection with either organism is high or unless the patient is unlikely to return for treatment. Treatment for MPC should include the following: -- Treatment for gonorrhea and chlamydia in patient populations with high prevalence of both infections, such as patients seen at many STD clinics. -- Treatment for chlamydia only, if the prevalence of N. gonorrhoeae is low but the likelihood of chlamydia is substantial. -- Await test results if the prevalence of both infections are low and if compliance with a recommendation for a return visit is likely. Follow-Up Follow-up should be as recommended for the infections for which the woman is being treated. Management of Sex Partners Management of sex partners of women with MPC should be appropriate for the STD (C. trachomatis or N. gonorrhoeae) identified. Partners should be notified, examined, and treated on the basis of test results. However, partners of patients who are treated presumptively should receive the same treatment as the index patient. Special Considerations HIV Infection - Persons with HIV infection and MPC should receive the same treatment as patients without HIV infection. Chlamydial Infections Chlamydial genital infection is common among adolescents and young adults in the United States. Asymptomatic infection is common among both men and women. Testing sexually active adolescent girls for chlamydial infection should be routine during gynecologic examination, even if symptoms are not present. Screening of young adult women 20-24 years of age also is suggested, particularly for those who do not consistently use barrier contraceptives and who have new or multiple partners. Periodic surveys of chlamydial prevalence among these groups should be conducted to confirm the validity of using these recommendations in specific clinical settings. Chlamydial Infections Among Adolescents and Adults The following recommended treatment regimens or the alternative regimens relieve symptoms and cure infection. Among women, several important sequelae may result from C. trachomatis infection, the most serious among them being PID, ectopic pregnancy, and infertility. Some women with apparently uncomplicated cervical infection already have subclinical upper reproductive tract infection. Treatment of cervical infection is believed to reduce the likelihood of sequelae, although few studies have demonstrated that antimicrobial therapy reduces the risk of subsequent ascending infections or decreases the incidence of long-term complications of tubal infertility and ectopic pregnancy. Treatment of infected patients prevents transmission to sex partners, and for infected pregnant women may prevent transmission of C. trachomatis to infants during birth. Treatment of sex partners will help to prevent re-infection of the index patient and infection of other partners. Because of the high prevalence of coinfection with C. trachomatis among patients with gonococcal infection, presumptive treatment for chlamydia of patients being treated for gonorrhea is appropriate, particularly if no diagnostic test for C. trachomatis infection will be performed (see Gonococcal Infections). Recommended Regimens - Doxycycline 100 mg orally 2 times a day for 7 days, or Azithromycin 1 g orally in a single dose. Alternative Regimens - Ofloxacin 300 mg orally 2 times a day for 7 days or Erythromycin base 500 mg orally 4 times a day for 7 days or Erythromycin ethylsuccinate 800 mg orally 4 times a day for 7 days or Sulfisoxazole 500 mg orally 4 times a day for 10 days (inferior efficacy to other regimens). Doxycycline and azithromycin appear similar in efficacy and toxicity; however, the safety and efficacy of azithromycin for persons less than or equal to 15 years of age have not been established. Doxycycline has a longer history of extensive use, safety, efficacy, and the advantage of low cost. Azithromycin has the advantage of single-dose administration. Ofloxacin is similar in efficacy to doxycycline and azithromycin, but is more expensive than doxycycline, cannot be used during pregnancy or with persons less than or equal to 17 years of age, and offers no advantage in dosing. Ofloxacin is the only quinolone with proven efficacy against chlamydial infection. Sulfisoxazole is the least desirable treatment because of inferior efficacy. Follow-Up - Patients do not need to be retested for chlamydia after completing treatment with doxycycline or azithromycin unless symptoms persist or re-infection is suspected. Retesting may be considered 3 weeks after completion of treatment with erythromycin, sulfisoxazole, or amoxicillin. This is usually unnecessary if the patient was treated with doxycycline, azithromycin, or ofloxacin. The validity of chlamydial culture testing performed at less than 3 weeks following completion of therapy among patients failing therapy has not been established. False-negative results may occur because of small numbers of chlamydial organisms. In addition, nonculture tests conducted at less than 3 weeks following completion of therapy for patients successfully treated may sometimes be false-positive because of the continued excretion of dead organisms. Some studies have demonstrated high rates of infection among women retested several months following treatment, presumably because of reinfection. Rescreening women several months following treatment may be an effective strategy for detecting further morbidity in some populations. Management of Sex Partners - Patients should be instructed to refer their sex partners for evaluation and treatment. Because exposure intervals have received limited evaluation, the following recommendations are somewhat arbitrary. Sex partners of symptomatic patients with C. trachomatis should be evaluated and treated for chlamydia if their last sexual contact with the index patient was within 30 days of onset of the index patient's symptoms. If the index patient is asymptomatic, sex partners whose last sexual contact with the index patient was within 60 days of diagnosis should be evaluated and treated. Health-care providers should treat the last sex partner even if last sexual intercourse took place before the foregoing time intervals. Patients should be instructed to avoid sex until they and their partners are cured. In the absence of microbiologic test-of-cure, this means until therapy is completed and patient and partner(s) are without symptoms. Special Considerations - Pregnancy - Doxycycline and ofloxacin are contraindicated for pregnant women, and sulfisoxazole is contraindicated for women during pregnancy near-term and for women who are nursing. The safety and efficacy of azithromycin among pregnant and lactating women have not been established. Repeat testing, preferably by culture, after completing therapy with the following regimens is recommended because there are few data regarding the effectiveness of these regimens, and the frequent gastrointestinal side effects of erythromycin may discourage a patient from complying with the prescribed treatment. Recommended Regimen for Pregnant Women - Erythromycin base 500 mg orally 4 times a day for 7 days. Alternative Regimens for Pregnant Women - Erythromycin base 250 mg orally 4 times a day for 14 days or Erythromycin ethylsuccinate 800 mg orally 4 times a day for 7 days or Erythromycin ethylsuccinate 400 mg orally 4 times a day for 14 days or If erythromycin cannot be tolerated: Amoxicillin 500 mg orally 3 times a day for 7-10 days. NOTE: Erythromycin estolate is contraindicated during pregnancy because of drug-related hepatotoxicity. Few data exist concerning the efficacy of amoxicillin. HIV Infection - Persons with HIV infection and chlamydial infection should receive the same treatment as patients without HIV infection. Chlamydial Infections Among Infants Prenatal screening of pregnant women can prevent chlamydial infection among neonates. Pregnant women less than 25 years of age and those with new or multiple sex partners should, in particular, be targeted for screening. Periodic surveys of chlamydial prevalence can be conducted to confirm the validity of using these recommendations in specific clinical settings. C. trachomatis infection of neonates results from perinatal exposure to the mother's infected cervix. The prevalence of C. trachomatis infection generally exceeds 5% among pregnant women, regardless of race/ethnicity or socioeconomic status. Neonatal ocular prophylaxis with silver nitrate solution or antibiotic ointments is ineffective in preventing perinatal transmission of chlamydial infection from mother to infant. However, ocular prophylaxis with those agents does prevent gonococcal ophthalmia and should be continued for that reason (see Prevention of Ophthalmia Neonatorum). Initial C. trachomatis perinatal infection involves mucous membranes of the eye, oropharynx, urogenital tract, and rectum. C. trachomatis infection among neonates can most often be recognized because of conjunctivitis developing 5-12 days after birth. Chlamydia is the most frequent identifiable infectious cause of ophthalmia neonatorum. C. trachomatis also is a common cause of subacute, afebrile pneumonia with onset from 1 to 3 months of age. Asymptomatic infections of the oropharynx, genital tract, and rectum among neonates also occur. Ophthalmia Neonatorum Caused by C. trachomatis A chlamydial etiology should be considered for all infants with conjunctivitis through 30 days of age. Diagnostic Considerations - Sensitive and specific methods to diagnose chlamydial ophthalmia for the neonate include isolation by tissue culture and nonculture tests, direct fluorescent antibody tests, and immunoassays. Giemsa-stained smears are specific for C. trachomatis, but are not sensitive. Specimens must contain conjunctival cells, not exudate alone. Specimens for culture isolation and nonculture tests should be obtained from the everted eyelid using a dacron-tipped swab or the swab specified by the manufacturer's test kit. A specific diagnosis of C. trachomatis infection confirms the need for chlamydial treatment not only for the neonate, but also for the mother and her sex partner(s). Ocular exudate from infants being evaluated for chlamydial conjunctivitis should also be tested for N. gonorrhoeae. Recommended Regimen - Erythromycin 50 mg/kg/day orally divided into 4 doses for 10- 14 days. Topical antibiotic therapy alone is inadequate for treatment of chlamydial infection and is unnecessary when systemic treatment is undertaken. Follow-Up - The possibility of chlamydial pneumonia should be considered. The efficacy of erythromycin treatment is approximately 80%; a second course of therapy may be required. Follow-up of infants to determine resolution is recommended. Management of Mothers and Their Sex Partners - The mothers of infants who have chlamydial infection and the mother's sex partners should be evaluated and treated following the treatment recommendations for adults with chlamydial infections (see Chlamydial Infections Among Adolescents and Adults). Infant Pneumonia Caused by C. trachomatis Characteristic signs of chlamydial pneumonia among infants include a repetitive staccato cough with tachypnea, and hyperinflation and bilateral diffuse infiltrates on a chest roentgenogram. Wheezing is rare, and infants are typically afebrile. Peripheral eosinophilia, documented in a complete blood count, is sometimes observed among infants with chlamydial pneumonia. Because variation from this clinical presentation is common, initial treatment and diagnostic tests should encompass C. trachomatis for all infants 1-3 months of age who have possible pneumonia. Diagnostic Considerations - Specimens should be collected from the nasopharynx for chlamydial testing. Tissue culture remains the definitive standard for chlamydial pneumonia; nonculture tests can be used with the knowledge that nonculture tests of nasopharyngeal specimens produce lower sensitivity and specificity than nonculture tests of ocular specimens. Tracheal aspirates and lung biopsy specimens, if collected, should be tested for C. trachomatis. The microimmunofluorescence test for C. trachomatis antibody is useful but not widely available. An acute IgM antibody titer greater than or equal to 1:32 is strongly suggestive of C. trachomatis pneumonia. Because of the delay in obtaining test results for chlamydia, inclusion of an agent active against C. trachomatis in the antibiotic regimen must frequently be decided on the basis of the clinical and radiologic findings. Conducting tests for chlamydial infection is worthwhile, not only to assist in the management of an infant's illness, but also to determine the need for treatment of the mother and her sex partners. Recommended Regimen - Erythromycin 50 mg/kg/day orally divided into 4 doses for 10- 14 days. Follow-Up - The effectiveness of erythromycin treatment is approximately 80%; a second course of therapy may be required. Follow-up of infants is recommended to determine that the pneumonia has resolved. Some infants with chlamydial pneumonia have had abnormal pulmonary function tests later in childhood. Management of Mothers and Their Sex Partners - Mothers of infants who have chlamydial infection and the mother's sex partners should be evaluated and treated according to the recommended treatment of adults with chlamydial infections (see Chlamydial Infections Among Adolescents and Adults). Infants Born to Mothers Who Have Chlamydial Infection Infants born to mothers who have untreated chlamydia are at high risk for infection and should be evaluated and treated as for infants with ophthalmia neonatorum caused by C. trachomatis. Chlamydial Infections Among Children Sexual abuse must be considered a cause of chlamydial infection among preadolescent children, although perinatally transmitted C. trachomatis infection of the nasopharynx, urogenital tract, and rectum may persist beyond 1 year (see Sexual Assault or Abuse of Children). Because of the potential for a criminal investigation and legal proceedings for sexual abuse, diagnosis of C. trachomatis among preadolescent children requires the high specificity provided by isolation in cell culture. The cultures should be confirmed by microscopic identification of the characteristic intracytoplasmic inclusions, preferably by fluorescein-conjugated monoclonal antibodies specific for C. trachomatis. Diagnostic Considerations - Nonculture chlamydia tests should not be used because of the possibility of false-positive test results. With respiratory tract specimens, false-positive test results can occur because of cross-reaction of test reagents with Chlamydia pneumoniae; with genital and anal specimens, false-positive test results occur because of cross-reaction with fecal flora. Recommended Regimen - Children who weigh less than 45 kg Erythromycin 50 mg/kg/day divided into four doses for 10-14 days. NOTE: The effectiveness of erythromycin treatment is approximately 80%; a second course of therapy may be required. Children who weigh greater than or equal to 45 kg but who are less than 8 years of age Use the same treatment regimens for these children as the adult regimens of erythromycin (see Chlamydial Infections Among Adolescents and Adults). Children greater than or equal to 8 years of age Use the same treatment regimens for these children as the adult regimens of doxycycline or tetracycline (see Chlamydial Infections Among Adolescents and Adults). Adult regimens of azithromycin also may be considered for adolescents. Other Management Considerations - See Sexual Assault or Abuse of Children. Follow-Up - Follow-up cultures are necessary to ensure that treatment has been effective. Gonococcal Infections Gonococcal Infections Among Adolescents and Adults An estimated 1 million new infections with N. gonorrhoeae occur in the United States each year. Most infections among men produce symptoms that cause the person to seek curative treatment soon enough to prevent serious sequelae -- but not soon enough to prevent transmission to others. Many infections among women do not produce recognizable symptoms until complications such as PID have occurred. PID, whether symptomatic or asymptomatic, can cause tubal scarring leading to infertility or ectopic pregnancy. Because gonococcal infections among women are often asymptomatic, a primary measure for controlling gonorrhea in the United States has been the screening of high-risk women. Uncomplicated Gonococcal Infections Recommended Regimens - Ceftriaxone 125 mg IM in a single dose or Cefixime 400 mg orally in a single dose or Ciprofloxacin 500 mg orally in a single dose or Ofloxacin 400 mg orally in a single dose PLUS A regimen effective against possible coinfection with C. trachomatis, such as doxycycline 100 mg orally 2 times a day for 7 days. Many antibiotics are safe and effective for treating gonorrhea, eradicating N. gonorrhoeae, ending the possibility of further transmission, relieving symptoms, and reducing the chances of sequelae. Selection of a treatment regimen for N. gonorrhoeae infection requires consideration of the anatomic site of infection, resistance of N. gonorrhoeae strains to antimicrobials, the possibility of concurrent infection with C. trachomatis, and the side effects and costs of the various treatment regimens. Because coinfection with C. trachomatis is common, persons treated for gonorrhea should be treated presumptively with a regimen that is effective against C. trachomatis (see Chlamydial Infections). Most experts agree that other regimens recommended for the treatment of C. trachomatis infection are also likely to be satisfactory for the treatment of co- infection (see Chlamydial Infections). However, studies have not been conducted to investigate possible interactions between other treatments for N. gonorrhoeae and C. trachomatis, including interactions influencing the effectiveness and side effects of cotreatment. In clinical trials, these recommended regimens cured greater than 95% of anal and genital infections; any of the regimens may be used for uncomplicated anal or genital infection. Published studies indicate that ceftriaxone 125 mg and ciprofloxacin 500 mg can cure greater than or equal to 90% of pharyngeal infections. If pharyngeal infection is a concern, one of these two regimens should be used. Ceftriaxone in a single dose of either 125 mg or 250 mg provides sustained, high bactericidal levels in the blood. Extensive clinical experience indicates that both doses are safe and effective for the treatment of uncomplicated gonorrhea at all sites. In the past, the 250 mg dose has been recommended on the supposition that the routine use of a higher dose may forestall the development of resistance. However, on the basis of ceftriaxone's activity against N. gonorrhoeae, its pharmacokinetics, and the results in clinical trials of doses as low as 62.5 mg, the 125 mg dose appears to have a therapeutic reserve at least as large as that of other accepted treatment regimens. No ceftriaxone-resistant strains of N. gonorrhoeae have been reported. The drawbacks of ceftriaxone are that it is expensive, currently unavailable in vials of less than 250 mg, and must be administered by injection. Some health-care providers believe that the discomfort of the injection may be reduced by using 1% lidocaine solution as a diluent. Ceftriaxone also may abort incubating syphilis, a concern when gonorrhea treatment is not accompanied by a 7-day course of doxycycline or erythromycin for the presumptive treatment of chlamydia. Cefixime has an antimicrobial spectrum similar to that of ceftriaxone, but the 400 mg oral dose does not provide as high nor as sustained a bactericidal level as does 125 mg of ceftriaxone. Cefixime appears to be effective against pharyngeal gonococcal infection, but few patients with pharyngeal infection have been included in studies. No gonococcal strains resistant to cefixime have been reported. The advantage of cefixime is that it can be administered orally. It is not known if the 400 mg dose can cure incubating syphilis. Ciprofloxacin at a dose of 500 mg provides sustained bactericidal levels in the blood. Clinical trials have demonstrated that both 250 mg and 500 mg doses are safe and effective for the treatment of uncomplicated gonorrhea at all sites. Most clinical experience in the United States has been with the 500 mg dose. Ciprofloxacin can be administered orally and is less expensive than ceftriaxone. No resistance has been reported in the United States, but strains with decreased susceptibility to some quinolones are becoming common in Asia and have been reported in North America. The 500 mg dose is recommended, rather than the 250 mg dose, because of the trend toward decreasing susceptibility to quinolones and because of rare reports of treatment failure. Quinolones are contraindicated for pregnant or nursing women and for persons less than or equal to 17 years of age on the basis of information from animal studies. Quinolones are not active against T. pallidum. Ofloxacin is active against N. gonorrhoeae, has favorable pharmacokinetics, and the 400 mg dose has been effective for the treatment of uncomplicated anal and genital gonorrhea. In published studies a 400 mg dose cured 22 (88%) of 25 pharyngeal infections. Alternative Regimens - -- Spectinomycin 2 g IM in a single dose. Spectinomycin has the disadvantages of being injectable, expensive, inactive against T. pallidum, and relatively ineffective against pharyngeal gonorrhea. In addition, resistant strains have been reported in the United States. However, spectinomycin remains useful for the treatment of patients who can tolerate neither cephalosporins nor quinolones. -- Injectable cephalosporin regimens other than ceftriaxone 125 mg that have demonstrated efficacy against uncomplicated anal or genital gonococcal infections include these injectable cephalosporins: ceftizoxime 500 mg IM in a single dose; cefotaxime 500 mg IM in a single dose; cefotetan 1 g IM in a single dose; and cefoxitin 2 g IM in a single dose. None of these injectable cephalosporins offers any advantage compared with ceftriaxone, and there is less clinical experience with them for the treatment of uncomplicated gonorrhea. Of these four regimens, ceftizoxime 500 mg appears to be the most effective according to cumulative experience in published clinical trials. -- Oral cephalosporin regimens other than cefixime 400 mg include cefuroxime axetil 1 g orally in a single dose and cefpodoxime proxetil 200 mg orally in a single dose. These two regimens have anti-gonococcal activity and pharmacokinetics less favorable than the 400 mg cefixime regimen, and there is less clinical experience with them in the treatment of gonorrhea. They have not been very effective against pharyngeal infections among the few patients studied. -- Quinolone regimens other than ciprofloxacin 500 mg and ofloxacin 400 mg include enoxacin 400 mg orally in a single dose; lomefloxacin 400 mg orally in a single dose; and norfloxacin 800 mg orally in a single dose. They appear to be safe and effective for the treatment of uncomplicated gonorrhea, but none appears to offer any advantage over ciprofloxacin at a dose of 500 mg or ofloxacin at 400 mg. Enoxacin and norfloxacin are active against N. gonorrhoeae, have favorable pharmacokinetics, and have been effective in clinical trials, but there is minimal experience with their use in the United States. Lomefloxacin is effective against N. gonorrhoeae and has very favorable pharmacokinetics, but there are few published clinical studies to support its use for the treatment of gonorrhea, and there is little experience with its use in the United States. Many other antimicrobials are active against N. gonorrhoeae. These guidelines are not intended to be a comprehensive list of all effective treatment regimens. Other Management Considerations - Persons treated for gonorrhea should be screened for syphilis by serology when gonorrhea is first detected. Gonorrhea treatment regimens that include ceftriaxone or a 7-day course of either doxycycline or erythromycin may cure incubating syphilis, but few data relevant to this topic are available. Follow-Up - Persons who have uncomplicated gonorrhea and who are treated with any of the regimens in these guidelines need not return for a test-of-cure. Those persons with symptoms persisting after treatment should be evaluated by culture for N. gonorrhoeae, and any gonococci isolated should be tested for antimicrobial susceptibility. Infections detected after treatment with one of the recommended regimens more commonly occur because of reinfection rather than treatment failure, indicating a need for improved sex partner referral and patient education. Persistent urethritis, cervicitis, or proctitis also may be caused by C. trachomatis and other organisms. Management of Sex Partners - Patients should be instructed to refer sex partners for evaluation and treatment. Sex partners of symptomatic patients who have N. gonorrhoeae infection should be evaluated and treated for N. gonorrhoeae and C. trachomatis infections, if their last sexual contact with the patient was within 30 days of onset of the patient's symptoms. If the index patient is asymptomatic, sex partners whose last sexual contact with the patient was within 60 days of diagnosis should be evaluated and treated. Health-care providers should treat the most recent sex partner, if last sexual intercourse took place before those time periods. Patients should be instructed to avoid sexual intercourse until patient and partner(s) are cured. In the absence of microbiologic test-of-cure, this means until therapy is completed and patient and partner(s) are without symptoms. Special Considerations - Allergy, Intolerance, or Adverse Reactions Persons who cannot tolerate cephalosporins should, in general, be treated with quinolones. Those who can take neither cephalosporins nor quinolones should be treated with spectinomycin, except for those patients who are suspected or known to have pharyngeal infection. For pharyngeal infections among persons who can tolerate neither a cephalosporin nor quinolones, some studies suggest that trimethoprim/ sulfamethoxazole may be effective at a dose of 720 mg trimethoprim/3,600 mg sulfamethoxazole orally once a day for 5 days. Pregnancy - Pregnant women should not be treated with quinolones or tetracyclines. Those infected with N. gonorrhoeae should be treated with a recommended or alternate cephalosporin. Women who cannot tolerate a cephalosporin should be administered a single dose of 2 g of spectinomycin IM. Erythromycin is the recommended treatment for presumptive or diagnosed C. trachomatis infection during pregnancy (see Chlamydial Infections). HIV Infection - Persons with HIV infection and gonococcal infection should receive the same treatment as persons not infected with HIV. Gonococcal Conjunctivitis Only one North American study of the treatment of gonococcal conjunctivitis among adults has been published in recent years. In that study, 12 of 12 patients responded favorably to a single 1 g IM injection of ceftriaxone. The recommendations that follow reflect the opinions of expert consultants. Treatment - Recommended Regimen - A single, 1 g dose of ceftriaxone should be administered IM, and the infected eye should be lavaged with saline solution once. Management of Sex Partners - As for uncomplicated infections, patients should be instructed to refer sex partner(s) for evaluation and treatment (see Uncomplicated Gonococcal Infections, Management of Sex Partners). Disseminated Gonococcal Infection Disseminated gonococcal infection (DGI) results from gonococcal bacteremia, often resulting in petechial or pustular acral skin lesions, asymmetrical arthalgias, tenosynovitis or septic arthritis -- and is occasionally complicated by hepatitis and, rarely, by endocarditis or meningitis. Strains of N. gonorrhoeae that cause DGI tend to cause little genital inflammation. These strains have become uncommon in the United States during the past decade. No North American studies of the treatment of DGI have been published recently. The recommendations that follow reflect the opinions of expert consultants. Treatment - Hospitalization is recommended for initial therapy, especially for patients who cannot be relied on to comply with treatment, for those for whom the diagnosis is uncertain, and for those who have purulent synovial effusions or other complications. Patients should be examined for clinical evidence of endocarditis and meningitis. Patients treated for DGI should be treated presumptively for concurrent C. trachomatis infection. Recommended Initial Regimen - Ceftriaxone 1 g IM or IV every 24 hours. Alternative Initial Regimens Cefotaxime 1 g IV every 8 hours or Ceftizoxime 1 g IV every 8 hours or For persons allergic to B-lactam drugs: Spectinomycin 2 g IM every 12 hours. All regimens should be continued for 24-48 hours after improvement begins; then therapy may be switched to one of the following regimens to complete a full week of antimicrobial therapy: Cefixime 400 mg orally 2 times a day or Ciprofloxacin 500 mg orally 2 times a day. NOTE: Ciprofloxacin is contraindicated for children, adolescents less than or equal to 17 years of age, and pregnant and lactating women. Management of Sex Partners Gonococcal infection is often asymptomatic in sex partners of patients with DGI. As for uncomplicated infections, patients should be instructed to refer sex partner(s) for evaluation and treatment (see Uncomplicated Gonococcal Infections, Management of Sex Partners). Gonococcal Meningitis and Endocarditis Recommended Initial Regimen - 1-2 g of ceftriaxone IV every 12 hours. Therapy for meningitis should be continued for 10-14 days and for endocarditis for at least 4 weeks. Treatment of complicated DGI should be undertaken in consultation with an expert. Management of Sex Partners - As for uncomplicated infections, patients should be instructed to refer sex partners for evaluation and treatment (see Uncomplicated Gonococcal Infections, Management of Sex Partners). Gonococcal Infections Among Infants Gonococcal infection among neonates usually results from peripartum exposure to infected cervical exudate of the mother. Gonococcal infection among neonates is usually an acute illness beginning 2-5 days after birth. The incidence of N. gonorrhoeae among neonates varies in U.S. communities, depends on the prevalence of infection among pregnant women, on whether pregnant women are screened for gonorrhea, and on whether newborns receive ophthalmia prophylaxis. The prevalence of infection is less than 1% in most prenatal patient populations, but may be higher in some settings. Of greatest concern are complications of ophthalmia neonatorum and sepsis, including arthritis and meningitis. Less serious manifestations at sites of infection include rhinitis, vaginitis, urethritis, and inflammation at sites of intrauterine fetal monitoring. Ophthalmia Neonatorum Caused by N. gonorrhoeae In most patient populations in the United States, C. trachomatis and nonsexually transmitted agents are more common causes of neonatal conjunctivitis than N. gonorrhoeae. However, N. gonorrhoeae is especially important because gonococcal ophthalmia may result in perforation of the globe and in blindness. Diagnostic Considerations Infants at high risk for gonococcal ophthalmia in the United States are those who do not receive ophthalmia prophylaxis, whose mothers have had no prenatal care, or whose mothers have a history of STDs or substance abuse. The presence of typical Gram-negative diplococci in a Gram-stained smear of conjunctival exudate suggests a diagnosis of N. gonorrhoeae conjunctivitis. Such patients should be treated presumptively for gonorrhea after obtaining appropriate cultures for N. gonorrhoeae; appropriate chlamydial testing should be done simultaneously. The decision not to treat presumptively for N. gonorrhoeae among patients without evidence of gonococci on a Gram-stained smear of conjunctival exudate, or among patients for whom a Gram-stained smear cannot be performed, must be made on a case-by-case basis after considering the previously described risk factors. A specimen of conjunctival exudate also should be cultured for isolation of N. gonorrhoeae, since culture is needed for definitive microbiologic identification and for antibiotic susceptibility testing. Such definitive testing is required because of the public health and social consequences for the infant and mother that may result from the diagnosis of gonococcal ophthalmia. Moraxella catarrhalis and other Neisseria species are uncommon causes of neonatal conjunctivitis that can mimic N. gonorrhoeae on Gram-stained smear. To differentiate N. gonorrhoeae from M. catarrhalis and other Neisseria species, the laboratory should be instructed to perform confirmatory tests on any colonies that meet presumptive criteria for N. gonorrhoeae. Recommended Regimen - Ceftriaxone 25-50 mg/kg IV or IM in a single dose, not to exceed 125 mg. NOTE: Topical antibiotic therapy alone is inadequate and is unnecessary if systemic treatment is administered. Other Management Considerations - Simultaneous infection with C. trachomatis has been reported and should be considered for patients who do not respond satisfactorily. The mother and infant should be tested for chlamydial infection at the same time that gonorrhea testing is done (see Ophthalmia Neonatorum Caused by C. trachomatis). Ceftriaxone should be administered cautiously among infants with elevated bilirubin levels, especially premature infants. Follow-Up - Infants should be admitted to the hospital and evaluated for signs of disseminated infection (e.g., sepsis, arthritis, and meningitis). One dose of ceftriaxone is adequate for gonococcal conjunctivitis, but many pediatricians prefer to maintain infants on antibiotics until cultures are negative at 48-72 hours. The decision on duration of therapy should be made with input from experienced physicians. Management of Mothers and Their Sex Partners - The mothers of infants with gonococcal infection and their sex partners should be evaluated and treated following the recommendations for treatment of gonococcal infections in adults (see Gonococcal Infections Among Adolescents and Adults). Disseminated Gonococcal Infection Among Infants Sepsis, arthritis, meningitis, or any combination thereof are rare complications of neonatal gonococcal infection. Gonococcal scalp abscesses also may develop as a result of fetal monitoring. Detection of gonococcal infection among neonates who have sepsis, arthritis, meningitis, or scalp abscesses requires cultures of blood, CSF, and joint aspirate on chocolate agar. Cultures of specimens from the conjunctiva, vagina, oropharynx, and rectum onto gonococcal selective medium are useful to identify sites of primary infection, especially if inflammation is present. Positive Gram-stained smears of exudate, CSF, or joint aspirate provide a presumptive basis for initiating treatment for N. gonorrhoeae. Diagnoses based on positive Gram-stained smears or presumptive isolation by cultures should be confirmed with definitive tests on culture isolates. Recommended Regimen - Ceftriaxone 25-50 mg/kg/day IV or IM in a single daily dose for 7 days, with a duration of 10-14 days, if meningitis is documented; or Cefotaxime 25 mg/kg IV or IM every 12 hours for 7 days, with a duration of 10-14 days, if meningitis is documented. Prophylactic Treatment for Infants Whose Mothers Have Gonococcal Infection Infants born to mothers who have untreated gonorrhea are at high risk for infection. Recommended Regimen in the Absence of Signs of Gonococcal Infection - Ceftriaxone 25-50 mg/kg IV or IM, not to exceed 125 mg, in a single dose. Other Management Considerations - If simultaneous infection with C. trachomatis has been reported, mother and infant should be tested for chlamydial infection. Follow-Up - Follow-up examination is not required. Management of Mothers and Their Sex Partners - The mothers of infants with gonococcal infection and the mother's sex partners should be evaluated and treated following the recommendations for treatment of gonococcal infections among adults (see Gonococcal Infections). Gonococcal Infections Among Children After the neonatal period, sexual abuse is the most common cause of gonococcal infection among preadolescent children (see Sexual Assault or Abuse of Children). Vaginitis is the most common manifestation of gonococcal infection among preadolescent children. PID following vaginal infection appears to be less common than among adults. Among sexually-abused children, anorectal and pharyngeal infections with N. gonorrhoeae are common and are frequently asymptomatic. Diagnostic Considerations - Because of the potential medical/legal use of the test results for N. gonorrhoeae among children, only standard culture systems for the isolation of N. gonorrhoeae should be used to diagnose N. gonorrhoeae for these children. Nonculture gonococcal tests, including Gram-stained smear, DNA probes, or EIA tests should not be used; none of these tests have been approved by the FDA for use in the oropharynx, rectum, or genital tract of children. Specimens from the vagina, urethra, pharynx, or rectum should be streaked onto selective media for isolation of N. gonorrhoeae. All presumptive isolates of N. gonorrhoeae should be confirmed by at least two tests that involve different principles, e.g., biochemical, enzyme substrate, or serologic. Isolates should be preserved to permit additional or repeated analysis. Recommended Regimen for Children - Children Who Weigh greater than 45 kg Children who weigh greater than or equal to 45 kg should be administered the same treatment regimens as those recommended for adults (see Gonococcal Infections). Children Who Weigh less than 45 kg The following treatment recommendations are for children with uncomplicated gonococcal vulvovaginitis, cervicitis, urethritis, pharyngitis, or proctitis. Ceftriaxone 125 mg IM in a single dose. Alternative Regimen - Spectinomycin 40 mg/kg (maximum 2 g) IM in a single dose. Children Who Weigh less than 45 kg and Who Have Bacteremia, Arthritis, or Meningitis Recommended Regimen - Ceftriaxone 50 mg/kg (maximum 1 g) IM or IV in a single dose daily for 7 days. NOTE: For meningitis, increase the duration of treatment to 10-14 days and the maximum dose to 2 g. Follow-Up - Follow-up cultures of specimens from infected sites are necessary to ensure that treatment has been effective. Other Management Considerations - Only parenteral cephalosporins are recommended for use among children. Ceftriaxone is approved for all gonococcal indications among children; cefotaxime is approved for gonococcal ophthalmia only. Oral cephalosporins (cefixime, cefuroxime axetil, cefpodoxime) have not received adequate evaluation in the treatment of gonococcal infections among pediatric patients to recommend their use. The pharmacokinetic activity of these drugs among adults cannot be extrapolated to children. All children with gonococcal infections should be evaluated for coinfection with syphilis and C. trachomatis. For a discussion of issues regarding sexual assault, refer to Sexual Assault or Abuse of Children. Ophthalmia Neonatorum Prophylaxis Instillation of a prophylactic agent into the eyes of all newborn infants is recommended to prevent gonococcal ophthalmia neonatorum and is required by law in most states. Although all the regimens that follow effectively prevent gonococcal eye disease, their efficacy in preventing chlamydial eye disease is not clear. Furthermore, they do not eliminate nasopharyngeal colonization with C. trachomatis. Treatment of gonococcal and chlamydial infections among pregnant women is the best method for preventing neonatal gonococcal and chlamydial disease. However, ocular prophylaxis should continue because it can prevent gonococcal ophthalmia and, in some populations, greater than 10% of pregnant women may receive no prenatal care. Prophylaxis - Recommended Preparations - Silver nitrate (1%) aqueous solution in a single application or Erythromycin (0.5%) ophthalmic ointment in a single application or Tetracycline ophthalmic ointment (1%) in a single application. One of the above preparations should be instilled into the eyes of every neonate as soon as possible after delivery. If prophylaxis is delayed (i.e., not administered in the delivery room), hospitals should establish a monitoring system to see that all infants receive prophylaxis. All infants should be administered ocular prophylaxis, whether delivery is vaginal or caesarian. Single-use tubes or ampules are preferable to multiple-use tubes. Bacitracin is not effective.
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