Three versus six weeks of antibiotic therapy for diabetic foot osteomyelitis: A prospective, randomized, non-inferiority pilot trial

BACKGROUND In patients with diabetic foot osteomyelitis (DFO) who underwent surgical debridement, we investigated whether a short (3 weeks), compared with a long (6 weeks) duration of systemic antibiotic treatment is associated with non-inferior results for clinical remission and adverse events (AE). METHODS In this prospective, randomized, non-inferiority, 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 end of therapy was two months. We compared outcomes using Cox regression and non-inferiority 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 debridement 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 to 36 (73%) in the 6-week arm (p=0.21). The number of AE was similar in the two study arms (17/44 vs. 16/49; p=0.51), as were the remission incidences in the per-protocol (PP) population (33/39 vs. 32/43; p=0.26). In multivariate analysis, treatment with the shorter antibiotic course was not significantly associated with remission (for the ITT population, hazard ratio 1.1, 95%CI 0.6-1.7; for the PP population hazard ratio 0.8, 95%CI 0.5-1.4). CONCLUSIONS In this randomized, controlled pilot trial, a post-debridement systemic antibiotic therapy course for DFO of 3-weeks gave similar (and statistically non-inferior) incidences of remission and AE to a course of 6 weeks.

PMID: 33242083