California Gonorrhea Treatment Guidelines --- Suspected Cephalosporin Treatment Failure
Updated Gonorrhea Treatment Recommendations
In the August 10, 2012 Morbidity and Mortality Weekly Report (MMWR), the Centers for Disease Control and Prevention (CDC) updated its Sexually Transmitted Disease Treatment Guidelines for gonorrhea treatment:
1. Dual antibiotic treatment with ceftriaxone 250 mg by intramuscular (IM) injection plus azithromycin 1 g orally (or doxycyline 100 mg orally twice a day for 7 days) is now the only recommended treatment regimen for uncomplicated urogenital and pharyngeal gonorrhea.
2. Azithromycin is preferred over doxycycline for dual antibiotic treatment due to high rates of tetracycline resistance among gonococcal isolates.
3. The oral cephalosporin cefixime is no longer a recommended therapy. Cefixime 400 mg orally plus azithromycin or doxycycline may be used as an alternative regimen if ceftriaxone is not available.
4. Other oral cephalosporins, including cefuroxime and cefpodoxime, are no longer considered alternative treatment regimens.
5. For cephalosporin-allergic patients, azithromycin 2 grams orally may be used as an alternative regimen.
6. Dual antibiotic treatment should be given regardless of any chlamydia test result.
Recommendations for Performing Tests-of-Cure (TOC)
Although CDC recommends that patients treated with alternative regimens (i.e., cefixime plus azithromycin or doxycycline, or azithromycin monotherapy) receive a (TOC) in 7 days, implementing routine TOCs for these patients may be challenging. Further, there are no data on TOC positivity rates in the absence of persistent symptoms, and cost-effectiveness thresholds for TOC have not been established.
In California, routine TOC after treatment is recommended for (1) all pregnant women diagnosed with gonorrhea, (2) cases of suspected treatment failure, and (3) patients treated with antibiotic regimens that are not recommended (e.g., fluoroquinolones). If programmatic resources allow, health care providers should consider also performing TOCs for gay men and other men who have sex with men (MSM) who have been treated with alternative regimens (i.e., cefixime plus azithromycin or doxycycline, or azithromycin monotherapy) as MSM are at higher risk of infection with cephalosporin-resistant gonorrhea.
Ideally, TOC should be performed using culture. Nucleic acid amplification tests (NAATs) are acceptable as a second choice. If the NAAT is positive, a confirmatory culture is recommended. Antimicrobial susceptibility testing (AST) is recommended for all positive TOC cultures.
Note: Clinicians using NAATs with combined results for chlamydia and gonorrhea should be aware that chalmydia results may remain positive for up to 3 weeks after successful treatment. Positive chlamydia test results before 3 weeks do not constitute treatment failure and do not require follow up TOC.
For assistance or clinical consultation regarding TOC, please call the STD Warm Line at (510) 620-3400, 8 am-5 pm, Monday-Friday and ask to speak with the clinician on call.
Suspected Cephalosporin Treatment Failure
Treatment failure should be suspected if (1) symptoms persist or recur following initial antibiotic therapy or (2) a TOC performed 7 days or more after treatment is positive. If symptoms are present, they may include:
• Persistent urethral discharge, dysuria, and/or pyuria (positive leukocyte esterase on urine dipstick)
• Persistent pharyngitis or odynophagia
• Persistent rectal discharge, pain, bleeding, pruritis, tenesmus, or painful defecation
• Persistent vaginal discharge, dysuria, or post-coital spotting
For patients with suspected treatment failure after dual therapy that included ceftriaxone or cefixime plus azithromycin or doxycycline, the following steps should be taken to ensure adequate testing, treatment, partner management, and follow up:
1. Obtain specimens for NAAT and culture at sites of sexual exposure (i.e., genital, rectal, pharyngeal). If gonorrhea culture is not available at your local laboratory, contact the California STD Control Branch clinician warm line at (510) 620-3400, M-F 8am-5pm for assistance.
2. Re-treat the patient with ceftriaxone 500 mg IM plus azithromycin 2 g orally in a single dose.
3. Inform your local health department of the case within 24 hours. Please also call the California STD Control Branch clinician warm line at (510) 620-3400.
4. Ensure that all of the patient’s partners in the last 60 days are notified and referred for testing and empiric treatment with ceftriaxone 500 mg IM plus azithromycin 2 g orally in a single dose. Your local health department may be able to provide assistance with partner notification.
5. Instruct the patient to abstain from oral, vaginal, or anal sex until one week after the patient and all of his/her partners are treated and all symptoms have resolved.
6. Ask the patient to return for a TOC one week after treatment with NAAT and culture.
The above recommendations are meant for patients with treatment failure after dual therapy with ceftriaxone or cefixime. Patients with persistent symptoms or a positive TOC after treatment with azithromycin monotherapy or a non-recommended regimen (e.g. fluoroquinolones) should be treated with ceftriaxone 250 mg IM plus azithromycin 1g orally.
Patients with persistent or recurrent symptoms who report interim sexual exposure to untreated or new partners have likely been reinfected. Patients with reinfection should be treated with ceftriaxone 250 mg IM plus azithromycin 1 g orally.
For assistance or clinical consultation regarding patients with ongoing treatment failure, patients with severe allergies, or other challenging cases, please call the STD Warm Line at (510) 620-3400, 8 am-5 pm, Monday-Friday and ask to speak with the clinician on call. For more information about STDs, please visit the STD Control Branch website.
Date Last Revised: 09/17/2012