Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
09/07/2009
Prospective/Retrospective
Retrospectively 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 H Wazait

ORCID ID

Contact details

Department of Urology
2nd floor
Jenner Building
Whittington Hospital
Highgate Hill
London
N19 5NF
United Kingdom
+44 (0)20 7288 5221

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0277104938

Study information

Scientific title

Acronym

Study hypothesis

Null hypothesis: antibiotic use on catheter removal does significantly reduce the risk of developing a clinically significant urinary tract infection (UTI)

Ethics approval

Not provided at time of registration

Study design

Randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Urinary tract infection (UTI)

Intervention

Removing the catheter and collection of two urine samples (immediately and 7 days later). Antibiotic or placebo prescribed for 48 hours after catheter removal.

Intervention type

Drug

Phase

Not Specified

Drug names

ciprofloxacin

Primary outcome measures

If antibiotics are advocated, this will become a guideline for all health professionals using catheters. If antibiotics are unnecessary, this will help to decrease the incidence of antimicrobial resistance and reduce the financial burden of antibiotic use in this group.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/10/2001

Overall trial end date

01/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

150 in-patients with in-dwelling catheters about to be removed will be blinded into two arms of the study (test and placebo)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

10/10/2001

Recruitment end date

01/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Urology
London
N19 5NF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Whittington Hospital NHS Trust (UK)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/15541126

Publication citations

  1. Results

    Wazait HD, Patel HR, van der Meulen JH, Ghei M, Al-Buheissi S, Kelsey M, Miller RA, Emberton M, A pilot randomized double-blind placebo-controlled trial on the use of antibiotics on urinary catheter removal to reduce the rate of urinary tract infection: the pitfalls of ciprofloxacin., BJU Int., 2004, 94, 7, 1048-1050, doi: 10.1111/j.1464-410X.2004.05102.x.

Additional files

Editorial Notes