Condition category
Urological and Genital Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
26/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul S Little

ORCID ID

Contact details

Primary Medical Care Group
Community Clinical Sciences Division
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8024 1062
psl3@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 97/14/06

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

10/09/2001

Overall trial end date

09/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects presenting with suspected urinary tract infections (UTI)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

309 (added 09/02/10; see publication)

Participant exclusion criteria

Pregnant women and women over the age of 75

Recruitment start date

10/09/2001

Recruitment end date

09/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care Group
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16882379
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20139214
3. 2010 cost effectiveness analysis in http://www.ncbi.nlm.nih.gov/pubmed/20139218

Publication citations

  1. Results

    Little P, Moore MV, Turner S, Rumsby K, Warner G, Lowes JA, Smith H, Hawke C, Leydon G, Arscott A, Turner D, Mullee M, Effectiveness of five different approaches in management of urinary tract infection: randomised controlled trial., BMJ, 2010, 340, c199.

  2. Cost effectiveness analysis

    Turner D, Little P, Raftery J, Turner S, Smith H, Rumsby K, Mullee M, , Cost effectiveness of management strategies for urinary tract infections: results from randomised controlled trial., BMJ, 2010, 340, c346.

  3. Little P, Turner S, Rumsby K, Warner G, Moore M, Lowes JA, Smith H, Hawke C, Mullee M, Developing clinical rules to predict urinary tract infection in primary care settings: sensitivity and specificity of near patient tests (dipsticks) and clinical scores., Br J Gen Pract, 2006, 56, 529, 606-612.

Additional files

Editorial Notes