Clinical trial NCT01388413: Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neurogenic Bladder
Urinary Tract Infection
Keywords: neurogenic bladder
urinary tract infection
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of symptomatic UTIs
timeFrame: During the 6-month follow-up
Secondary outcomes:
measure: The number of feverish UTIs
timeFrame: During the 6-month follow-up
measure: The number of hospitalizations
timeFrame: During the 6-month follow-up.
measure: The duration of UTI-related hospitalizations
timeFrame: During the 6-month follow-up
measure: The tolerance level to the Weekly Oral Cyclic Antibiotic Programme, measured by any adverse effects to antibiotics
timeFrame: During the 6-month follow-up.
measure: The global antibiotic consumption.
timeFrame: During the 6-month follow-up
measure: The number of urine culture negative
timeFrame: During the 6-month follow-up
measure: 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.
timeFrame: During the 6-month follow-up
measure: the quality of life
timeFrame: During the 6-month follow-up
Other outcomes:
Locations:
city: Garches
country: France
facility: University Hospital, Raymond Poincaré / APHP
city: Nantes
country: France
facility: University Hospital, St Jacques / NANTES
city: Rennes
country: France
facility: University Hospital, Pontchaillou / RENNES
city: Tours
country: France
facility: University Hospital, Bretonneau / TOURS
Study officials:
affiliation: University Hospital, Tours
name: Louis BERNARD, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.