Development and randomised controlled trial of dipsticks and diagnostic algorithms for the management of urinary tract infection
| ISRCTN | ISRCTN03525333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03525333 |
| Secondary identifying numbers | HTA 97/14/06 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 26/02/2010
- 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 Paul S Little
Scientific
Scientific
Primary Medical Care Group
Community Clinical Sciences Division
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| Phone | +44 (0)23 8024 1062 |
|---|---|
| psl3@soton.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 1. To develop and test the use of different algorithms/symptom scores in the diagnosis of urinary tract infection (UTI) 2. To develop and test the use of different dipstick strategies in the diagnosis of UTI 3. To assess the cost effectiveness of common management strategies in the diagnosis and treatment of UTI 4. To assess the effect of the different strategies on patient satisfaction, beliefs and behaviour Two phases: 1. Dipstick and score validation 2. Block randomised open trial of management strategies More details can be found at: http://www.hta.ac.uk/1205 Protocol can be found at: http://www.hta.ac.uk/protocols/199700140006.pdf |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urinary tract infection |
| Intervention | Phase 1. Different symptom scores (naive Bayesian, adjusted Bayesian, symptom counts) and combinations of dipstick results will be developed to predict 'standard' monosodium urate (MSU) diagnosis in half the subjects (randomly chosen). The optimal strategies will be determined - from sensitivity, specificity, predictive values, likelihood ratios, and workload implications from the R.O. curves and tested with previous scores in the other half of the data. Phase 2. This will be preceded by a development phase to determine the feasibility of trial procedures and exact strategy for each group derived from the results of phase 1. Patients will be block randomised to five groups: 1. Empiric antibiotic treatment (3 day course of trimethoprim) 2. Treatment based on algorithm/score (from phase 1) 3. Treatment based on dipstick (based on phase 1) 4. Treatment based on positive MSU examination and culture 5. Control group (symptomatic treatment based on alkalinization of urine and other symptomatic measures) |
| Intervention type | Other |
| Primary outcome measure | 1. Symptom diary 2. Satisfaction 3. Belief in antibiotics 4. Notes review for 4.1. reattendance 4.2. complications 4.3. referral 5. Costs 5.1. manual timing for GP and other staff costs 5.2. marginal costs in processing the MSUs |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 10/09/2001 |
| Completion date | 09/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 309 (added 09/02/10; see publication) |
| Key inclusion criteria | Subjects presenting with suspected urinary tract infections (UTI) |
| Key exclusion criteria | Pregnant women and women over the age of 75 |
| Date of first enrolment | 10/09/2001 |
| Date of final enrolment | 09/09/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Primary Medical Care Group
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/08/2006 | Yes | No | |
| Other publications | cost effectiveness analysis | 05/02/2010 | Yes | No | |
| Results article | results | 05/02/2010 | Yes | No |
