Effectiveness of Prolonged Antibiotic Prophylaxis in Radical Cystectomy: Preliminary Analysis of the MACS Randomized Clinical Trial.

Abstract

Standard 24-hour antibiotic prophylaxis is widely employed to minimize the risk of infection complications within 30 days following radical cystectomy. However, a considerable variety of protocols and drug combinations don't prevent a high complication rate, ranging from 37 to 67%. This paper presents the interim analysis of the MACS clinical trial, comparing antibiotic prophylaxis regimens by duration. To evaluate the rate of infection complications within 30 days following radical cystectomy by comparing standard 24-hour antibiotic prophylaxis (Group A) with a prolonged 120-hour regimen (Group B). Patients were randomized in a 1 : 1 ratio. The primary endpoint was the evaluation of the frequency of infection complications. The secondary endpoints were the rate of re-administrating antibiotics and the dynamics of the inflammation biomarker. A total of 78 patients (85.0% of the sample size) were enrolled (Group A: 40 and Group B: 38). The baseline and perioperative features were balanced between groups. The overall complication rate was higher in Group A (65.0% vs. 41.1%, p = 0.043). The infection complication rate was 2.7 times higher in the standard antibiotic prophylaxis group: 37.5% compared to 18.4% cases in Group B (p = 0.041), and upper urinary tract infection was more frequent in Group A (22.5% vs. 2.6%). The prolonged antibiotic prophylaxis reduced the overall frequency of infection complications compared with standard 24-hour prophylaxis (RR = 0.12; 95% CI 0.02-0.88; p = 0.037). In this interim analysis, the administration of prolonged antibiotic prophylaxis over 120 hours appears to be safe and feasible, demonstrating a reduction in the total number of complications, particularly infection complications.