Three Weeks Versus Six Weeks of Antibiotic Therapy for Diabetic Foot Osteomyelitis: A Prospective, Randomized, Noninferiority Pilot Trial
Three Weeks Versus Six Weeks of Antibiotic Therapy for Diabetic Foot Osteomyelitis: A Prospective, Randomized, Noninferiority Pilot Trial
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DOI：
10.1093/cid/ciaa1758
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发表时间：
2021-10-01
影响因子：
11.8
通讯作者：
Uckay, Ilker
中科院分区：
文献类型：
--
作者：
Gariani, Karim;Truong-Thanh Pham;Uckay, Ilker
背景在接受手术清创的糖尿病足骨髓炎（DFO）患者中，我们研究了短时间（3周）与长时间（6周）全身抗生素治疗是否与临床缓解和不良事件（AE）的非劣效结果相关。在这项前瞻性、随机、非劣效性初步试验中，我们将手术清创后的DFO患者随机（1：1分配）接受3周或6周的抗生素治疗。治疗结束后的最短随访时间为2个月。我们使用考克斯回归和非劣效性分析（25%界值，把握度80%）比较结果。在93例入组患者（18%为女性;中位年龄65岁）中，44例随机分配至3周组，49例随机分配至6周组。手术清创的中位次数为1次（范围：0-2次干预）。在意向治疗（ITT）人群中，3周组37例（84%）患者缓解，6周组36例（73%）患者缓解（P= 0.21）。两个研究组的AE数量相似（17/44 vs 16/49; P= 0.51），符合方案（PP）人群的缓解发生率也相似（33/39 vs 32/43; P= 0.26）。在多变量分析中，较短抗生素疗程与缓解无显著相关性（ITT人群：风险比[HR]，1.1 [95%可信区间{CI}，0.6 -1.7]; PP人群：HR，0.8 [95% CI：0.5 -1.4]）。在这项随机对照初步试验中，DFO的清创后全身抗生素治疗疗程为3周，缓解和AE发生率与6周疗程相似（且具有统计学非劣效性）。
Background. In patients with diabetic foot osteomyelitis (DFO) who underwent surgical debridement, we investigated whether a short (3 weeks) duration compared with a long (6 weeks) duration of systemic antibiotic treatment is associated with noninferior results for clinical remission and adverse events (AEs).Methods. In this prospective, randomized, noninferiority pilot trial, we randomized (allocation 1:1) patients with DFO after surgical debridement to either a 3-week or a 6-week course of antibiotic therapy. The minimal duration of follow-up after the end of therapy was 2 months. We compared outcomes using Cox regression and noninferiority analyses (25% margin, power 80%).Results. Among 93 enrolled patients (18% females; median age 65 years), 44 were randomized to the 3-week arm and 49 to the 6-week arm. The median number of surgical debridements was 1 (range, 0-2 interventions). In the intention-to-treat (ITT) population, remission occurred in 37 (84%) of the patients in the 3-week arm compared with 36 (73%) in the 6-week arm (P=.21). The number of AEs was similar in the 2 study arms (17/44 vs 16/49; P=.51), as were the remission incidences in the per-protocol (PP) population (33/39 vs 32/43; P=.26). In multivariate analysis, treatment with the shorter antibiotic course was not significantly associated with remission (ITT population: hazard ratio [HR], 1.1 [95% confidence interval {CI}, .6-1.7]; PP population: HR, 0.8 [95% CI: .5-1.4]).Conclusions. In this randomized controlled pilot trial, a postdebridement systemic antibiotic therapy course for DFO of 3 weeks gave similar (and statistically noninferior) incidences of remission and AE to a course of 6 weeks.