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NCT Number: NCT01388413

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.

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Key information

Conditions

Neurogenic Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Tract Infection Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Raymond Poincaré / APHP, Garches, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weekly Oral Cyclic Antibiotic programme

Drug

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 outcomes

  1. Number of symptomatic UTIs

    Time frame: During the 6-month follow-up

    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 outcomes

  1. The number of feverish UTIs

    Time frame: During the 6-month follow-up

    The number of feverish UTIs

  2. The number of hospitalizations

    Time frame: During the 6-month follow-up.

    The number of hospitalizations

  3. The duration of UTI-related hospitalizations

    Time frame: During the 6-month follow-up

    The duration of UTI-related hospitalizations

  4. 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.

    The tolerance level to the Weekly Oral Cyclic Antibiotic Programme, measured by any adverse effects to antibiotics

  5. The global antibiotic consumption.

    Time frame: During the 6-month follow-up

    The global antibiotic consumption.

  6. The number of urine culture negative

    Time frame: During the 6-month follow-up

    The number of urine culture negative

  7. 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

    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.

  8. the quality of life

    Time frame: During the 6-month follow-up

    A scale to measure the quality of life.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Acronym: PACHIU

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Jul 6, 2011
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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