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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/15541126
Publication citations
-
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.