Condition category
Urological and Genital Diseases
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
11/04/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.olvg.nl/

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

Publication citations

Additional files

Editorial Notes