CompletedPhase 4

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

France45 participantsStarted 2011-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of symptomatic UTIs

Timeframe: During the 6-month follow-up

Trial details

NCT IDNCT01388413

SponsorUniversity Hospital, Tours

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01