Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder (PACHIU)
This study is not yet open for participant recruitment.
Verified July 2011 by University Hospital, Tours
Sponsor:
University Hospital, Tours
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01388413
First received: June 23, 2011
Last updated: July 7, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neurogenic Bladder Urinary Tract Infection |
Drug: Weekly Oral Cyclic Antibiotic programme |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital, Tours:
Primary Outcome Measures:
- Number of symptomatic UTIs [ Time Frame: During the 6-month follow-up ] [ Designated as safety issue: No ]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 Outcome Measures:
- The number of feverish UTIs [ Time Frame: During the 6-month follow-up ] [ Designated as safety issue: No ]The number of feverish UTIs
- The number of hospitalizations [ Time Frame: During the 6-month follow-up. ] [ Designated as safety issue: No ]The number of hospitalizations
- The duration of UTI-related hospitalizations [ Time Frame: During the 6-month follow-up ] [ Designated as safety issue: No ]The duration of UTI-related hospitalizations
- The tolerance level to the Weekly Oral Cyclic Antibiotic Programme, measured by any adverse effects to antibiotics [ Time Frame: During the 6-month follow-up. ] [ Designated as safety issue: Yes ]The tolerance level to the Weekly Oral Cyclic Antibiotic Programme, measured by any adverse effects to antibiotics
- The global antibiotic consumption. [ Time Frame: During the 6-month follow-up ] [ Designated as safety issue: No ]The global antibiotic consumption.
- The number of urine culture negative [ Time Frame: During the 6-month follow-up ] [ Designated as safety issue: No ]The number of urine culture negative
- 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. [ Time Frame: During the 6-month follow-up ] [ Designated as safety issue: No ]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 quality of life [ Time Frame: During the 6-month follow-up ] [ Designated as safety issue: No ]A scale to measure the quality of life.
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Weekly Oral Cyclic Antibiotic programme |
Drug: 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.
|
| No Intervention: Classic care |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- subject over 18 years of age
- having a neurogenic bladder with automatic catheter and pharmacologic disconnection of the detrusor muscle
- having more than 6 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 >400 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388413
Contacts
| Contact: Louis BERNARD, MD-PhD | +33(0)2.47.47.37.14 | louis.bernard@univ-tours.fr |
| Contact: Yoann DESVIGNES | +33(0)2.47.47.46.32 | yoann.desvignes@med.univ-tours.fr |
Locations
| France | |
| University Hospital, Raymond Poincaré / APHP | Not yet recruiting |
| Garches, France, 92380 | |
| Contact: Aurélien DINH, MD | |
| Principal Investigator: Aurélien DINH, MD | |
| University Hospital, St Jacques / NANTES | Not yet recruiting |
| Nantes, France, 44000 | |
| Contact: Brigitte PERROUIN-VERBE, MD-PhD | |
| Principal Investigator: Brigitte PERROUIN-VERBE, MD-PhD | |
| Kerpape Mutualistic Functional Reeducation and Rehabilitation Center | Not yet recruiting |
| Ploemeur, France, 56270 | |
| Contact: Jacques KERDRAON, MD | |
| Principal Investigator: Jacques KERDRAON, MD | |
| University Hospital, Pontchaillou / RENNES | Not yet recruiting |
| Rennes, France, 35000 | |
| Contact: Andrea MANUNTA, MD | |
| Principal Investigator: Andrea MANUNTA, MD | |
| University Hospital, Bretonneau / TOURS | Not yet recruiting |
| Tours, France, 37000 | |
| Contact: Louis BERNARD, MD-PhD | |
| Principal Investigator: Louis BERNARD, MD-PhD | |
Sponsors and Collaborators
University Hospital, Tours
Investigators
| Principal Investigator: | Louis BERNARD, MD-PhD | University Hospital, Tours |
More Information
No publications provided
| Responsible Party: | Directrice des Affaires Médicales et de la Recherche, University Hospital, TOURS |
| ClinicalTrials.gov Identifier: | NCT01388413 History of Changes |
| Other Study ID Numbers: | PHRI06-LB/PACHIU, 2010-021241-44, A101183-72, 2010-R31 |
| Study First Received: | June 23, 2011 |
| Last Updated: | July 7, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Tours:
|
neurogenic bladder urinary tract infection |
Additional relevant MeSH terms:
|
Urinary Bladder, Neurogenic Urinary Tract Infections Neurologic Manifestations Nervous System Diseases Urinary Bladder Diseases Urologic Diseases |
Signs and Symptoms Infection Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013