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
Secondary identifying numbers NL899 (NTR923)
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

Onze Lieve Vrouwe Gasthuis
Department of Pediatrics
P.O. Box 95500
Amsterdam
1090 HM
Netherlands

Email a.m.bouwman@olvg.nl

Study information

Study designRandomised, double blinded, placebo controlled, parallel group, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleAntibiotic prophylaxis in prevention of urinary tract infections caused by removal of a bladder catheter in children
Study acronymAUB study
Study objectivesA 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) studiedUrinary tract infections, bladder catheterisation in children
InterventionAmoxicillin/clavulanic acid prophylaxis versus placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Amoxicillin/clavulanic acid
Primary outcome measureUrinary tract infection (positive urine culture)
Secondary outcome measures1. Bacteriuria
2. Side effects of antibiotics
Overall study start date01/06/2007
Completion date01/06/2009

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit18 Years
SexNot Specified
Target number of participants94
Key inclusion criteria1. Children between zero and 18 years
2. Short term (greater than two hours, less than seven days) bladder catheterisation
3. Informed consent
Key exclusion criteria1. Use of antibiotics
2. Renal function disorders
3. Allergy to antibiotics
Date of first enrolment01/06/2007
Date of final enrolment01/06/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Onze Lieve Vrouwe Gasthuis
Amsterdam
1090 HM
Netherlands

Sponsor information

Onze Lieve Vrouwe Gasthuis (OLVG) (The Netherlands)
Hospital/treatment centre

Department of Pediatrics
P.O. Box 95500
Amsterdam
1090 HM
Netherlands

Website http://www.olvg.nl/
ROR logo "ROR" https://ror.org/01d02sf11

Funders

Funder type

Hospital/treatment centre

Onze Lieve Vrouwe Gasthuis (OLVG) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

22/09/2021: Proactive update review. No publications found. Search options exhausted.