Antibiotics with catheter withdrawal (a randomised double blind placebo controlled trial)

ISRCTN ISRCTN06126383
DOI https://doi.org/10.1186/ISRCTN06126383
Secondary identifying numbers N0277104938
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
09/07/2009
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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr H Wazait
Scientific

Department of Urology
2nd floor, Jenner Building
Whittington Hospital
Highgate Hill
London
N19 5NF
United Kingdom

Phone +44 (0)20 7288 5221

Study information

Study designRandomised double blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNull hypothesis: antibiotic use on catheter removal does significantly reduce the risk of developing a clinically significant urinary tract infection (UTI)
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrinary tract infection (UTI)
InterventionRemoving the catheter and collection of two urine samples (immediately and 7 days later). Antibiotic or placebo prescribed for 48 hours after catheter removal.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)ciprofloxacin
Primary outcome measureIf 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 measuresNot provided at time of registration
Overall study start date10/10/2001
Completion date01/10/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants150
Key inclusion criteria150 in-patients with in-dwelling catheters about to be removed will be blinded into two arms of the study (test and placebo)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment10/10/2001
Date of final enrolment01/10/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Urology
London
N19 5NF
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Hospital/treatment centre

Whittington Hospital NHS Trust (UK)

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2004 Yes No