Neurogenic BladderPhase 4PACHIUNCT01388413
Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder
A Phase 4 study testing Weekly Oral Cyclic Antibiotic programme in people with Neurogenic Bladder and Urinary Tract Infection, run by University Hospital, Tours at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder, Urinary Tract Infection
- What is being tested?
- Weekly Oral Cyclic Antibiotic programme
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesFrance
- Study dates
- Aug 2011to Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- creatinine clearance <60 ml/min
- patient under guardianship
- women who are pregnant, nursing, or who may become pregnant
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital, Raymond Poincaré / APHP
Garches, 92380
University Hospital, St Jacques / NANTES
Nantes, 44000
University Hospital, Pontchaillou / RENNES
Rennes, 35000
University Hospital, Bretonneau / TOURS
Tours, 37000
About this study
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
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.
- Conditions
- Neurogenic Bladder, Urinary Tract Infection
- Being tested
- Weekly Oral Cyclic Antibiotic programme
- Keywords
- neurogenic bladder, urinary tract infection
- Medical subject headings
- Urinary Bladder, Neurogenic, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly Oral Cyclic Antibiotic programmeDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Weekly Oral Cyclic Antibiotic programme | Experimental | Not described Receives: Drug: Weekly Oral Cyclic Antibiotic programme |
| Classic care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the 6-month follow-up
Secondary outcomes (8)
The number of feverish UTIs
The number of feverish UTIs
Measured: During the 6-month follow-up
The number of hospitalizations
The number of hospitalizations
Measured: During the 6-month follow-up.
The duration of UTI-related hospitalizations
The duration of UTI-related hospitalizations
Measured: During the 6-month follow-up
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
Measured: During the 6-month follow-up.
The global antibiotic consumption.
The global antibiotic consumption.
Measured: During the 6-month follow-up
The number of urine culture negative
The number of urine culture negative
Measured: 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.
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.
Measured: During the 6-month follow-up
the quality of life
A scale to measure the quality of life.
Measured: During the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis BERNARD, MD-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388413
- Sponsor's protocol ID
- PHRI06-LB/PACHIU
- Other IDs
- 2010-021241-44, A101183-72, 2010-R31
- Acronym
- PACHIU
- Status last verified
- Feb 2017
- First submitted
- 23 Jun 2011
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31867616
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01388413
- Acronym / sponsor ID
- PACHIU / PHRI06-LB/PACHIU
- Conditions
- Neurogenic Bladder, Urinary Tract Infection
- Keywords
- neurogenic bladder, urinary tract infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Oral Cyclic Antibiotic programme | Experimental | Drug: Weekly Oral Cyclic Antibiotic programme |
| Classic care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weekly Oral Cyclic Antibiotic programmeThe 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. | Drug | Weekly Oral Cyclic Antibiotic programme |
Primary outcome
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).
8 secondary outcomes
The number of feverish UTIs
Time frame: During the 6-month follow-up
The number of hospitalizations
Time frame: During the 6-month follow-up.
The duration of UTI-related hospitalizations
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
Time frame: During the 6-month follow-up.
The global antibiotic consumption.
Time frame: During the 6-month follow-up
The number of urine culture negative
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.
Time frame: During the 6-month follow-up
the quality of life
Time frame: During the 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 31867616Dinh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis BERNARD, MD-PhD principal investigator
University Hospital, Tours
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Weekly Oral Cyclic Antibiotic programme in people with Neurogenic Bladder and Urinary Tract Infection, run by University Hospital, Tours at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of symptomatic UTIs (time frame: During the 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01388413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.