Antibiotics with catheter withdrawal (a randomised double blind placebo controlled trial)
| ISRCTN | ISRCTN06126383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06126383 |
| Protocol serial number | N0277104938 |
| Sponsor | Department of Health |
| Funder | Whittington Hospital NHS Trust (UK) |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Null 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) studied | 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 / device / biological / vaccine name(s) | ciprofloxacin |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 150 |
| Key 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) |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 10/10/2001 |
| Date of final enrolment | 01/10/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Urology
London
N19 5NF
United Kingdom
N19 5NF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
