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

NCT01388413 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Weekly Oral Cyclic Antibiotic programme

The Weekly Oral Cyclic Antibiotic Programme consisted of the alternate administration of an antibiotic once per week. The antibiotics that were chosen (efficient for urinary tract infection, well tolerated, low selection pressure) included : Amoxicillin 6000 mg, Amoxicillin/clavulanic acid 3000 mg, Cefixime 400 mg, Fosfomycin trometamol 6000 mg, Trimethoprim/sulfamethoxazole 2400 mg. During week A,the patient received a single antibiotic (A), and the following week B the patient was given another antibiotic (B). For each patient, antibiotics were specifically chosen according to the results of urine cultures.

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Louis BERNARD, MD-PhD · University Hospital, Tours

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2016-01-31
Completion
2017-02-28

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01388413 on ClinicalTrials.gov