drugset / Trial / NCT01388413

Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder

NCT01388413

Phase 4 Completed 45 enrolled University Hospital, Tours
RandomizedParallel-groupOpen-labelPrevention

Summary

Symptomatic urinary tract infections (UTIs) are one of the main causes of morbidity and the main cause of re-hospitalization in subjects with neurogenic bladder. Long-term antibiotic therapy increases the risk of multi-resistant bacterial infections, without reducing the rate of symptomatic UTIs. Our non-comparative preliminary study has shown that Weekly Oral Cyclic Antibiotic Programme (single, weekly dose of antibiotic X on even weeks, and antibiotic Y on odd weeks) seem to drastically reduce both the number of symptomatic UTIs and the number of hospitalizations in patients with neurogenic bladder, without affecting bacterial ecology. The objective of this study is to validate this preliminary work with a large-scale randomized, parallel-group, multicenter study.

Timeline

Start
2011-08
Primary completion
2016-01
Completion
2017-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 6000 mg Oral
Subject Amoxicillin/clavulanic acid Unknown 3000 mg Oral
Subject Cefixime Other / unclassified 400 mg Oral
Subject Fosfomycin Small molecule 6000 mg Oral
Subject Trimethoprim/sulfamethoxazole Unknown 2400 mg Oral