This trial is active, not recruiting.

Conditions neurogenic bladder, urinary tract infection
Treatment weekly oral cyclic antibiotic programme
Phase phase 4
Sponsor University Hospital, Tours
Start date August 2011
End date February 2016
Trial size 80 participants
Trial identifier NCT01388413, 2010-021241-44, 2010-R31, A101183-72, PHRI06-LB/PACHIU


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
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.
(No Intervention)

Primary Outcomes

Number of symptomatic UTIs
time frame: During the 6-month follow-up

Secondary Outcomes

The number of feverish UTIs
time frame: During the 6-month follow-up
The number of hospitalizations
time frame: During the 6-month follow-up.
The duration of UTI-related hospitalizations
time frame: During the 6-month follow-up
The tolerance level to the Weekly Oral Cyclic Antibiotic Programme, measured by any adverse effects to antibiotics
time frame: During the 6-month follow-up.
The global antibiotic consumption.
time frame: During the 6-month follow-up
The number of urine culture negative
time frame: During the 6-month follow-up
The emergence of multi-resistant bacteria in urine (cultures), digestive bacteria (anal swabs), oro-pharynx bacteria (nasal swabs), and semi-quantitative research of multi-resistant bacteria in the stool.
time frame: During the 6-month follow-up
the quality of life
time frame: During the 6-month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - subject over 18 years of age - having a neurogenic bladder with automatic catheter and pharmacologic disconnection of the detrusor muscle - having at least 4 symptomatic UTIs per year with bacterial sensitivity to the chosen antibiotics - having given full consent to participate in the study - being the recipient of social security benefits Exclusion Criteria: - known allergy or hypersensitivity to useful antibiotics (to which the bacterium or bacteria are sensitive) or to one of their components - other contraindication in the administering of useful antibiotics - urinary volume flow >500 ml during automatic catheter - different urinary drainage method than automatic catheter - occurrence of stones in the urinary tract - infection due to endo urinary material (urinary prosthesis, ureteral stent) - creatinine clearance <60 ml/min - patient under guardianship - women who are pregnant, nursing, or who may become pregnant

Additional Information

Official title A Randomized, Multicenter, Parallel Group Study to Evaluate Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder
Principal investigator Louis BERNARD, MD-PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University Hospital, Tours.