Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder
NCT ID: NCT01388413
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
45 participants
INTERVENTIONAL
2011-08-31
2017-02-28
Brief Summary
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The objective of this study is to validate this preliminary work with a large-scale randomized, parallel-group, multicenter study.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Weekly Oral Cyclic Antibiotic programme
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.
Classic care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Louis BERNARD, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Tours
Locations
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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, , France
Countries
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References
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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.
Other Identifiers
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PHRI06-LB/PACHIU
Identifier Type: -
Identifier Source: org_study_id
2010-021241-44
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A101183-72
Identifier Type: OTHER
Identifier Source: secondary_id
2010-R31
Identifier Type: OTHER
Identifier Source: secondary_id