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. 2024 Jul 3;22(4):235-242.
doi: 10.1080/20905998.2024.2373399. eCollection 2024.

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

Mariya Vladimirovna Berkut  1 , Aleksey Mikhailovich Belyaev  1 , Tatyana Yurievna Galunova  1 , Nikolay Ivanovich Tyapkin  2 , Sergey Aleksandrovich Reva  3 , Alexander Konstantinovich Nosov  1
Affiliations

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

Mariya Vladimirovna Berkut et al. Arab J Urol. .

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.

Keywords: Radical cystectomy; antibiotic prophylaxis; carbapenemase; infection complications; surgical site infection.

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Conflict of interest statement

No potential conflict of interest was reported by the author(s).

Figures

Figure 1.
Figure 1.
Consolidated standards of reporting trials (CONSORT) flowchart.
Figure 2.
Figure 2.
Time to the development of events of clinical interest (event-free survival) within 30 days following radical cystectomy with urinary diversion (HR = 0.447; 0.191–1.050, p = 0.065).
Figure 3.
Figure 3.
Forest plot of risk factors for infectious complications of clinical interest.
See this image and copyright information in PMC

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