Orthopedic Infectious Diseases Online Library

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  • 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.

  • BACKGROUND The management of complex orthopedic infections usually includes a prolonged course of intravenous antibiotic agents. We investigated whether oral antibiotic therapy is noninferior to intravenous antibiotic therapy for this indication. METHODS We enrolled adults who were being treated for bone or joint infection at 26 U.K. centers. Within 7 days after surgery (or, if the infection was being managed without surgery, within 7 days after the start of antibiotic treatment), participants were randomly assigned to receive either intravenous or oral antibiotics to complete the first 6 weeks of therapy. Follow-on oral antibiotics were permitted in both groups. The primary end point was definitive treatment failure within 1 year after randomization. In the analysis of the risk of the primary end point, the noninferiority margin was 7.5 percentage points. RESULTS Among the 1054 participants (527 in each group), end-point data were available for 1015 (96.3%). Treatment failure occurred in 74 of 506 participants (14.6%) in the intravenous group and 67 of 509 participants (13.2%) in the oral group. Missing end-point data (39 participants, 3.7%) were imputed. The intention-to-treat analysis showed a difference in the risk of definitive treatment failure (oral group vs. intravenous group) of −1.4 percentage points (90% confidence interval [CI], −4.9 to 2.2; 95% CI, −5.6 to 2.9), indicating noninferiority. Complete-case, per-protocol, and sensitivity analyses supported this result. The between-group difference in the incidence of serious adverse events was not significant (146 of 527 participants [27.7%] in the intravenous group and 138 of 527 [26.2%] in the oral group; P=0.58). Catheter complications, analyzed as a secondary end point, were more common in the intravenous group (9.4% vs. 1.0%). CONCLUSIONS Oral antibiotic therapy was noninferior to intravenous antibiotic therapy when used during the first 6 weeks for complex orthopedic infection, as assessed by treatment failure at 1 year. (Funded by the National Institute for Health Research; OVIVA Current Controlled Trials number, ISRCTN91566927. opens in new tab.)

Last update from database: 11/10/24, 4:26 PM (UTC)