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

NCT01388413 | Completed Phase 4 DMC

• 4 other identifiers: PHRI06-LB/PACHIU2010-021241-44A101183-722010-R31
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

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.

Conditions

Neurogenic Bladder; Urinary Tract Infection

Keywords

neurogenic bladder; urinary tract infection

Outcome Measures

Primary Outcomes (1)

• 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).

  During the 6-month follow-up

Secondary Outcomes (8)

• The number of feverish UTIs

  During the 6-month follow-up

• The number of hospitalizations

  During the 6-month follow-up.

• The duration of UTI-related hospitalizations

  During the 6-month follow-up

• The tolerance level to the Weekly Oral Cyclic Antibiotic Programme, measured by any adverse effects to antibiotics

  During the 6-month follow-up.

• The global antibiotic consumption.

  During the 6-month follow-up

Study Arms (2)

Weekly Oral Cyclic Antibiotic programme

EXPERIMENTAL

Drug: Weekly Oral Cyclic Antibiotic programme

Classic care

NO INTERVENTION

Interventions

Weekly Oral Cyclic Antibiotic programme DRUG

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.

Weekly Oral Cyclic Antibiotic programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (4)

University Hospital, Raymond Poincaré / APHP

Garches, 92380, France

Location

University Hospital, St Jacques / NANTES

Nantes, 44000, France

Location

University Hospital, Pontchaillou / RENNES

Rennes, 35000, France

Location

University Hospital, Bretonneau / TOURS

Tours, 37000, France

Location

Related Publications (1)

• Dinh A, Hallouin-Bernard MC, Davido B, Lemaignen A, Bouchand F, Duran C, Even A, Denys P, Perrouin-Verbe B, Sotto A, Lavigne JP, Bruyere F, Grall N, Tavernier E, Bernard L. Weekly Sequential Antibioprophylaxis for Recurrent Urinary Tract Infections Among Patients With Neurogenic Bladder: A Randomized Controlled Trial. Clin Infect Dis. 2020 Dec 15;71(12):3128-3135. doi: 10.1093/cid/ciz1207.

  PMID: 31867616 RESULT

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Louis BERNARD, MD-PhD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: July 6, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2017
• Last Updated: December 22, 2025

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)