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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neurogenic Bladder, Urinary Tract Infection

Intervention / Treatment
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* Drug: Weekly Oral Cyclic Antibiotic programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly Oral Cyclic Antibiotic programme<br> | Drug: Weekly Oral Cyclic Antibiotic programme<br>* 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.<br>|
| No Intervention: Classic care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of feverish UTIs | The number of feverish UTIs | During the 6-month follow-up | 
| The number of hospitalizations | The number of hospitalizations | During the 6-month follow-up. | 
| The duration of UTI-related hospitalizations | 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 | 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. | The global antibiotic consumption. | During the 6-month follow-up | 
| The number of urine culture negative | The number of urine culture negative | 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. | 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 quality of life | A scale to measure the quality of life. | During the 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurogenic bladder, urinary tract infection