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

Primary Purpose

Neurogenic Bladder, Urinary Tract Infection

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Weekly Oral Cyclic Antibiotic programme
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neurogenic Bladder focused on measuring neurogenic bladder, urinary tract infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Raymond Poincaré / APHP
  • University Hospital, St Jacques / NANTES
  • University Hospital, Pontchaillou / RENNES
  • University Hospital, Bretonneau / TOURS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Weekly Oral Cyclic Antibiotic programme

Classic care

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

The number of feverish UTIs
The number of feverish UTIs
The number of hospitalizations
The number of hospitalizations
The duration of UTI-related hospitalizations
The duration of UTI-related hospitalizations
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
The global antibiotic consumption.
The global antibiotic consumption.
The number of urine culture negative
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.
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
A scale to measure the quality of life.

Full Information

First Posted
June 23, 2011
Last Updated
February 23, 2017
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT01388413
Brief Title
Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder
Acronym
PACHIU
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder, Urinary Tract Infection
Keywords
neurogenic bladder, urinary tract infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weekly Oral Cyclic Antibiotic programme
Arm Type
Experimental
Arm Title
Classic care
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Weekly Oral Cyclic Antibiotic programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of symptomatic UTIs
Description
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).
Time Frame
During the 6-month follow-up
Secondary Outcome Measure Information:
Title
The number of feverish UTIs
Description
The number of feverish UTIs
Time Frame
During the 6-month follow-up
Title
The number of hospitalizations
Description
The number of hospitalizations
Time Frame
During the 6-month follow-up.
Title
The duration of UTI-related hospitalizations
Description
The duration of UTI-related hospitalizations
Time Frame
During the 6-month follow-up
Title
The tolerance level to the Weekly Oral Cyclic Antibiotic Programme, measured by any adverse effects to antibiotics
Description
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.
Title
The global antibiotic consumption.
Description
The global antibiotic consumption.
Time Frame
During the 6-month follow-up
Title
The number of urine culture negative
Description
The number of urine culture negative
Time Frame
During the 6-month follow-up
Title
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.
Description
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
Title
the quality of life
Description
A scale to measure the quality of life.
Time Frame
During the 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis BERNARD, MD-PhD
Organizational Affiliation
University Hospital, Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Raymond Poincaré / APHP
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
University Hospital, St Jacques / NANTES
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
University Hospital, Pontchaillou / RENNES
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
University Hospital, Bretonneau / TOURS
City
Tours
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31867616
Citation
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.
Results Reference
derived

Learn more about this trial

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

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