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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021241-44 | EudraCT Number | ||
| A101183-72 | Other Identifier | Afssaps | |
| 2010-R31 | Other Identifier | CPP |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly Oral Cyclic Antibiotic programme | Experimental |
| |
| Classic care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During the 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| The number of feverish UTIs | The number of feverish UTIs | During the 6-month follow-up |
| The number of hospitalizations | The number of hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis BERNARD, MD-PhD | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Raymond Poincaré / APHP | Garches | 92380 | France | |||
| University Hospital, St Jacques / NANTES |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31867616 | Result | 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. |
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|
| During the 6-month follow-up. |
| The duration of UTI-related hospitalizations | The duration of UTI-related hospitalizations | 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 | During the 6-month follow-up. |
| The global antibiotic consumption. | The global antibiotic consumption. | During the 6-month follow-up |
| The number of urine culture negative | The number of urine culture negative | 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. | During the 6-month follow-up |
| the quality of life | A scale to measure the quality of life. | During the 6-month follow-up |
| Nantes |
| 44000 |
| France |
| University Hospital, Pontchaillou / RENNES | Rennes | 35000 | France |
| University Hospital, Bretonneau / TOURS | Tours | 37000 | France |
| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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