Prolonged 120-h meropenem antibiotic prophylaxis in radical cystectomy compared to 24h standard antibiotic prophylaxis: Final analysis of the randomized clinical trial

Abstract

Background Standard 24-h antibiotic prophylaxis (AP) is widely employed to minimize the risk of infection complications (ICs) within 30 days following a radical cystectomy (RC). However, a considerable variety of prophylaxis protocols do not prevent a high ICs rate after surgery (37–67%). Therefore, antibiotic’s type and its duration are still controversial for AP.( Objective To compare standard 24-h AP with a prolonged 120-h regimen in a multicenter randomized clinical trial. Methods Patients were randomized in a 1:1 ratio to standard 24-h AP regimen (Group A) versus the prolonged meropenem AP 120-h (Group B). The primary endpoint was an event rate defined as the frequency of ICs within 30 days. The secondary endpoint were biomarker’s analysis and antibiotic re-administration rate (ArAR). Results A total of 92 patients were enrolled. The Clavien-Dindo complications rate did not differ between the groups (p = 0.065), however the overall complication rate was higher in Group A (63.0% vs. 34.8%, p = 0.007). The infection complication rate was 2.75 times higher in the standard antibiotic prophylaxis group: 47.8% compared to 17.4% cases in Group B (p = 0.002). The new prolonged antibiotic regimen decreased the risk of ICs (OR 0.23; 95% CI 0.08–.598; p = 0.003). The event-free survival for ICs of clinical interest in group A was 7.00 days and in group B was 9.00 days (HR = 0.447; 0.191–1.050, p = 0.065). The ArAR was higher in Group A -47.8%, while in Group B it was only in 17.4% of the cases. The incidence of bacteriuria before RC was the same between groups (p = 0.666), however, after stent removal the risk of a positive culture was lower in group B (RR = 0.64; 95% CI 0.37–1.08; p = 0.05). Conclusions The administration AP over 120-h appears to be safe and feasible, demonstrating a reduction in the total number of complications and ArAR. Trial registration in Clinical Trials: NCT05392634. Trial registration in Clinical Trials: NCT05392634.