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
Protocol serial number	HTA 97/14/06
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

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
Email	psl3@soton.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	09/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	309
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

United Kingdom
England

Study participating centre

Primary Medical Care Group

Southampton
SO16 5ST
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	Peer reviewed?	Patient-facing?
Results article	results	01/08/2006	Yes	No
Results article	results	05/02/2010	Yes	No
Other publications	cost effectiveness analysis	05/02/2010	Yes	No