Department of Internal Medicine, University of Michigan Medical School, University of Michigan, Ann Arbor, Michigan, USA.
Division of Infectious Diseases, University of Michigan Medical School, University of Michigan, Ann Arbor, Michigan, USA.
Clin Infect Dis. 2024 Feb 17;78(2):277-282. doi: 10.1093/cid/ciad606.
Recurrent Clostridioides difficile infection (rCDI) occurs frequently, and concomitant antibiotic (CA) during the initial episode for treatment of non-CDI is a major risk factor. We sought to address the comparative efficacy of fidaxomicin versus vancomycin in the setting of CA during the initial CDI episode.
We conducted a randomized, controlled, open-label trial at 2 hospitals in Ann Arbor, Michigan. We consecutively consented and enrolled hospitalized patients ≥18 years old with diarrhea, a positive test for C. difficile, and ≥1 qualifying CA. Complicated CDI, CDI treatment for >24 hours prior to enrollment, and planned long-term (>12 weeks) CA use were notable exclusions. Clinical cure was defined as resolution of diarrhea for 2 consecutive days maintained until 2 days after therapy, and rCDI as recurrent diarrhea with positive testing ≤30 days after initial treatment. Patients were randomized to fidaxomicin or vancomycin.
Baseline characteristics were similar in the 2 groups of 144 patients. Rates of clinical cure (73% vs 62.9%, P = .195) and rCDI (3.3% vs 4.0%; P > .99) were similar for fidaxomicin and vancomycin in the intention-to-treat and per-protocol cohorts, respectively. Only 4 patients developed rCDI.
In this study of patients with CDI receiving CA, a numerically higher proportion were cured with fidaxomicin versus vancomycin, but this result did not reach statistical significance. Overall recurrence was lower than anticipated in both arms compared with previous studies that did not extend duration of CDI treatment during CA.
www.clinicaltrials.gov (NCT02692651).
复发性艰难梭菌感染（rCDI）很常见，在治疗非 CDI 的初始发作期间同时使用抗生素（CA）是一个主要的危险因素。我们旨在探讨在初始 CDI 发作期间使用 CA 时，非达霉素与万古霉素的相对疗效。
我们在密歇根州安阿伯的 2 家医院进行了一项随机、对照、开放标签试验。我们连续同意并招募了≥18 岁的住院患者，这些患者有腹泻、艰难梭菌阳性检测结果和≥1 种符合条件的 CA。复杂的 CDI、在入组前 CDI 治疗>24 小时以及计划长期（>12 周）使用 CA 是显著的排除标准。临床治愈定义为连续 2 天腹泻缓解，直至治疗后 2 天，rCDI 定义为初始治疗后≤30 天复发腹泻和阳性检测结果。患者被随机分配到非达霉素或万古霉素组。
144 例患者的两组基线特征相似。意向治疗和方案治疗队列中，非达霉素组的临床治愈率（73% vs. 62.9%，P=0.195）和 rCDI 发生率（3.3% vs. 4.0%；P>0.99）与万古霉素组相似。只有 4 例患者发生 rCDI。
在这项接受 CA 的 CDI 患者研究中，与万古霉素相比，非达霉素治疗的患者治愈比例略高，但这一结果未达到统计学意义。与未延长 CA 期间 CDI 治疗持续时间的先前研究相比，两组的总体复发率均低于预期。
