| - candidate number | 2502 |
| - NTR Number | NTR923 |
| - ISRCTN | ISRCTN65525844 |
| - Date ISRCTN created | 11-apr-2007 |
| - date ISRCTN requested | 24-mrt-2007 |
| - Date Registered NTR | 6-mrt-2007 |
| - Secondary IDs | |
| - Public Title | Antibiotic prophylaxis in prevention of urinary tract infections caused by removal of a bladder catheter in children |
| - Scientific Title | Antibiotic prophylaxis in prevention of urinary tract infections caused by removal of a bladder catheter in children |
| - ACRONYM | AUB study |
| - hypothesis | A short course of amoxicillin/clavulanic acid will not reduce the number of urinary tract infections in children that have been catheterized during a short period. |
| - Healt Condition(s) or Problem(s) studied | Children, Antibiotic prophylaxis, Bladder catheterization |
| - Inclusion criteria | 1. Children between 0 and 18 years; 2. Short term (> 2hours, less than 7 days) bladder catheterisation; 3. Informed consent |
| - Exclusion criteria | 1. Use of antibiotics; 2. Renal function disorders; 3. Allergy to antibiotics |
| - mec approval received | no |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-jun-2007 |
| - planned closingdate | 1-jun-2009 |
| - Target number of participants | 94 |
| - Interventions | Amoxicillin/clavulanic acid prophylaxis versus placebo |
| - Primary outcome | Urinary tract infection (positive urine culture) |
| - Secondary outcome | 1. Bacteriuria 2. Side effects of antibiotics |
| - Timepoints | |
| - Trial web site | |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | A.M. Bouwman |
| - CONTACT for SCIENTIFIC QUERIES | A.M. Bouwman |
| - Sponsor/Initiator | Onze Lieve Vrouwe Gasthuis, Department of Pediatrics |
| - Funding (Source(s) of Monetary or Material Support) | Onze Lieve Vrouwe Gasthuis, Department of Pediatrics |
| - Publications | |
| - Brief summary | Randomised double blind placebo controlled study in order to determine wheter a short course of antibiotics during the removal of a bladder catheter in children will reduce the number of urinary tract infections. |
| - Main changes (audit trail) | |
| - RECORD | 6-mrt-2007 - 12-apr-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl