Department of Medicine, University of Washington, Seattle, Washington, USA.
HIV/STD Program, Public Health-Seattle & King County, Seattle, Washington, USA.
Clin Infect Dis. 2021 Sep 7;73(5):824-831. doi: 10.1093/cid/ciab153.
Azithromycin and doxycycline are both recommended treatments for rectal Chlamydia trachomatis (CT) infection, but observational studies suggest that doxycycline may be more effective.
This randomized, double-blind, placebo-controlled trial compared azithromycin (single 1-g dose) versus doxycycline (100 mg twice daily for 7 days) for the treatment of rectal CT in men who have sex with men (MSM) in Seattle and Boston. Participants were enrolled after a diagnosis of rectal CT in clinical care and underwent repeated collection of rectal swabs for nucleic acid amplification testing (NAAT) at study enrollment and 2 weeks and 4 weeks postenrollment. The primary outcome was microbiologic cure (CT-negative NAAT) at 4 weeks. The complete case (CC) population included participants with a CT-positive NAAT at enrollment and a follow-up NAAT result; the intention-to-treat (ITT) population included all randomized participants.
Among 177 participants enrolled, 135 (76%) met CC population criteria for the 4-week follow-up visit. Thirty-three participants (19%) were excluded because the CT NAAT repeated at enrollment was negative. Microbiologic cure was higher with doxycycline than azithromycin in both the CC population (100% [70 of 70] vs 74% [48 of 65]; absolute difference, 26%; 95% confidence interval [CI], 16-36%; P < .001) and the ITT population (91% [80 of 88] vs 71% [63 of 89]; absolute difference, 20%; 95% CI, 9-31%; P < .001).
A 1-week course of doxycycline was significantly more effective than a single dose of azithromycin for the treatment of rectal CT in MSM.
NCT03608774.
阿奇霉素和强力霉素均被推荐用于治疗直肠沙眼衣原体（CT）感染，但观察性研究表明强力霉素可能更有效。
这项随机、双盲、安慰剂对照试验比较了阿奇霉素（单次 1 克剂量）与强力霉素（100 毫克，每日 2 次，共 7 天）治疗西雅图和波士顿男男性行为者（MSM）直肠 CT 的效果。参与者在临床护理中诊断为直肠 CT 后入组，并在研究入组时、入组后 2 周和 4 周时重复采集直肠拭子进行核酸扩增检测（NAAT）。主要结局是 4 周时的微生物学治愈率（CT-NAAT 阴性）。完整病例（CC）人群包括入组时 CT-NAAT 阳性且随访 NAAT 结果的参与者；意向治疗（ITT）人群包括所有随机分组的参与者。
在入组的 177 名参与者中，有 135 名（76%）符合 4 周随访的 CC 人群标准。33 名参与者（19%）因入组时重复的 CT NAAT 为阴性而被排除。在 CC 人群和 ITT 人群中，强力霉素的微生物学治愈率均高于阿奇霉素，分别为 100%（70/70）与 74%（48/65）（绝对差异，26%；95%置信区间[CI]，16-36%；P<0.001）和 91%（80/88）与 71%（63/89）（绝对差异，20%；95%CI，9-31%；P<0.001）。
1 周疗程的强力霉素治疗 MSM 直肠 CT 的疗效明显优于单次阿奇霉素治疗。
NCT03608774。
