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

Phase 4

Completed

• Conditions: Neurogenic Bladder; Urinary Tract Infection
• Interventions: Drug: Weekly Oral Cyclic Antibiotic programme

• Registration Number: NCT01388413
• Lead Sponsor: University Hospital, Tours

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-07-01
• Study First Posted: 2011-07-06
• Study Start: 2011-08
• Primary Completion: 2016-01
• Status Verified: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weekly Oral Cyclic Antibiotic programme	Weekly Oral Cyclic Antibiotic programme	-

Primary Outcome Measures

Name	Time	Method
Number of symptomatic UTIs	During the 6-month follow-up	Symptomatic UTIs are defined by the presence of infection or reinfection by the same bacteria, in combination with the presence of definite clinical signs of infection (autonomous hyper-reflexivity, spasticity, leakage, contractures, pyuria, fever, shivers).

Secondary Outcome Measures

Name	Time	Method
The number of feverish UTIs	During the 6-month follow-up	The number of feverish UTIs
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.	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.
The duration of UTI-related hospitalizations	During the 6-month follow-up	The duration of UTI-related hospitalizations
The global antibiotic consumption.	During the 6-month follow-up	The global antibiotic consumption.
The number of urine culture negative	During the 6-month follow-up	The number of urine culture negative
the quality of life	During the 6-month follow-up	A scale to measure the quality of life.
The number of hospitalizations	During the 6-month follow-up.	The number of hospitalizations
The tolerance level to the Weekly Oral Cyclic Antibiotic Programme, measured by any adverse effects to antibiotics	During the 6-month follow-up.	The tolerance level to the Weekly Oral Cyclic Antibiotic Programme, measured by any adverse effects to antibiotics

Trial Locations

Locations (4)

University Hospital, Bretonneau / TOURS; 🇫🇷 Tours, France

University Hospital, St Jacques / NANTES; 🇫🇷 Nantes, France

University Hospital, Pontchaillou / RENNES; 🇫🇷 Rennes, France

University Hospital, Raymond Poincaré / APHP; 🇫🇷 Garches, France