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

Regional University Hospital Center (CHRU)

Status and phase

Completed

Phase 4

Conditions

Urinary Tract Infection

Neurogenic Bladder

Treatments

Drug: Weekly Oral Cyclic Antibiotic programme

Study type

Interventional

Funder types

Other

Identifiers

NCT01388413

PHRI06-LB/PACHIU

2010-021241-44 (EudraCT Number)

A101183-72 (Other Identifier)

2010-R31 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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