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

University Hospital, Tours45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Neurogenic Bladder Urinary Tract Infection

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

University Hospital, Raymond Poincaré / APHP

Garches, France

University Hospital, St Jacques / NANTES

Nantes, France

University Hospital, Pontchaillou / RENNES

Rennes, France

University Hospital, Bretonneau / TOURS

Tours, France

Outcomes

Primary Outcomes

Number of symptomatic UTIs

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).