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

Urinary Tract Infection Clinical Trial

— PACHIU  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388413
• Other study ID #: PHRI06-LB/PACHIU
• Secondary ID: 2010-021241-44A1
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2011
• Last updated: February 23, 2017
• Start date: August 2011
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Neurogenic Bladder
• Urinary Bladder, Neurogenic
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

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