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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University Hospital, Tours.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01388413
First received: June 23, 2011
Last updated: July 7, 2011
Last verified: July 2011

June 23, 2011
July 7, 2011
July 2011
December 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01388413 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 antibiocycle, 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 antibiocycle, 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.
Not Provided
Not Provided
 
Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Neurogenic Bladder
  • Urinary Tract Infection
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.
  • Experimental: Weekly Oral Cyclic Antibiotic programme
    Intervention: Drug: Weekly Oral Cyclic Antibiotic programme
  • No Intervention: Classic care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
France
 
NCT01388413
PHRI06-LB/PACHIU, 2010-021241-44, A101183-72, 2010-R31
Yes
Directrice des Affaires Médicales et de la Recherche, University Hospital, TOURS
University Hospital, Tours
Not Provided
Principal Investigator: Louis BERNARD, MD-PhD University Hospital, Tours
University Hospital, Tours
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP