Contact information
Type
Scientific
Primary contact
Dr A M Bouwman
ORCID ID
Contact details
Onze Lieve Vrouwe Gasthuis
Department of Pediatrics
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
a.m.bouwman@olvg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
AUB study
Study hypothesis
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
Not provided at time of registration
Study design
Randomised, double blinded, placebo controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Urinary tract infections, bladder catheterisation in children
Intervention
Amoxicillin/clavulanic acid prophylaxis versus placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Amoxicillin/clavulanic acid
Primary outcome measures
Urinary tract infection (positive urine culture)
Secondary outcome measures
1. Bacteriuria
2. Side effects of antibiotics
Overall trial start date
01/06/2007
Overall trial end date
01/06/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
94
Participant exclusion criteria
1. Use of antibiotics
2. Renal function disorders
3. Allergy to antibiotics
Recruitment start date
01/06/2007
Recruitment end date
01/06/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Onze Lieve Vrouwe Gasthuis
Amsterdam
1090 HM
Netherlands
Sponsor information
Organisation
Onze Lieve Vrouwe Gasthuis (OLVG) (The Netherlands)
Sponsor details
Department of Pediatrics
P.O. Box 95500
Amsterdam
1090 HM
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Onze Lieve Vrouwe Gasthuis (OLVG) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary