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
Overview
- Phase
- Phase 4
- Intervention
- Weekly Oral Cyclic Antibiotic programme
- Conditions
- Neurogenic Bladder
- Sponsor
- University Hospital, Tours
- Enrollment
- 45
- Locations
- 4
- Primary Endpoint
- Number of symptomatic UTIs
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
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
Arms & Interventions
Weekly Oral Cyclic Antibiotic programme
Intervention: Weekly Oral Cyclic Antibiotic programme
Outcomes
Primary Outcomes
Number of symptomatic UTIs
Time Frame: During the 6-month follow-up
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).
Secondary Outcomes
- The number of feverish UTIs(During the 6-month follow-up)
- 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)
- The duration of UTI-related hospitalizations(During the 6-month follow-up)
- The global antibiotic consumption.(During the 6-month follow-up)
- The number of urine culture negative(During the 6-month follow-up)
- the quality of life(During the 6-month follow-up)
- The number of 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.)