Antibiotic prophylaxis in prevention of urinary tract infections caused by removal of a bladder catheter in children
| ISRCTN | ISRCTN65525844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65525844 |
| Protocol serial number | NL899 (NTR923) |
| Sponsor | Onze Lieve Vrouwe Gasthuis (OLVG) (The Netherlands) |
| Funder | Onze Lieve Vrouwe Gasthuis (OLVG) (The Netherlands) |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 22/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A M Bouwman
Scientific
Scientific
Onze Lieve Vrouwe Gasthuis
Department of Pediatrics
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
| a.m.bouwman@olvg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blinded, placebo controlled, parallel group, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Antibiotic prophylaxis in prevention of urinary tract infections caused by removal of a bladder catheter in children |
| Study acronym | AUB study |
| Study objectives | A short course of amoxicillin/clavulanic acid will not reduce the number of urinary tract infections in children that have been catheterised during a short period. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urinary tract infections, bladder catheterisation in children |
| Intervention | Amoxicillin/clavulanic acid prophylaxis versus placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amoxicillin/clavulanic acid |
| Primary outcome measure(s) |
Urinary tract infection (positive urine culture) |
| Key secondary outcome measure(s) |
1. Bacteriuria |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 94 |
| Key inclusion criteria | 1. Children between zero and 18 years 2. Short term (greater than two hours, less than seven days) bladder catheterisation 3. Informed consent |
| Key exclusion criteria | 1. Use of antibiotics 2. Renal function disorders 3. Allergy to antibiotics |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Onze Lieve Vrouwe Gasthuis
Amsterdam
1090 HM
Netherlands
1090 HM
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
22/09/2021: Proactive update review. No publications found. Search options exhausted.
