Condition category
Urological and Genital Diseases
Date applied
10/09/2013
Date assigned
10/09/2013
Last edited
01/12/2016
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

Mr Nigel Kirby

ORCID ID

Contact details

South East Wales Trials Unit
Centre for Health Sciences Research
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
-
kirbyn@cardiff.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14828

Study information

Scientific title

Point of care testing for urinary tract infection in primary care: Stages 3 & 4 - a randomised controlled trial

Acronym

POETIC Stage 3 and 4

Study hypothesis

The randomised controlled trial (RCT) aims to quantify the costs and effects of an optimised POCT guided diagnostic and treatment regime for symptoms of uncomplicated UTI. 540 adult female patients from the 4 participating countries will be randomised to either the POCT arm or the standard care (SC) arm. Participants randomised to the intervention arm will have their treatment guided by the Flexicultâ„¢ POCT. This strategy will be based upon guidelines on the management of uncomplicated UTI in primary care in participating countries, and use of a POCT to guide antibiotic management. Urine and stool samples will be obtained at presentation (baseline) and two weeks later. The primary outcome will be appropriateness of antibiotic prescribing.

Ethics approval

12/WA/0394

Study design

Randomised interventional and observational trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

POCT arm or the standard care (SC) arm.

Flexicult Test, The Intervention is a Flexicult test.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Appropriate antibiotic use on day 3

Secondary outcome measures

Antibiotic choice in relation to presence of infection and organism susceptibility

Overall trial start date

01/06/2013

Overall trial end date

31/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Females age 18 years and above presenting with suspected uncomplicated urinary tract infection.
2. Presenting with at least one of three key urinary tract symptoms (dysuria, urgency including nocturia, and frequency)
3. Able to provide informed consent and willing to complete a patient diary.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 540; UK Sample Size: 270

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

23/07/2013

Recruitment end date

31/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South East Wales Trials Unit
Cardiff
CF14 4YS
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Heath Park
Cardiff
CF14 4XN
United Kingdom

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/

Funders

Funder type

Government

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25425162

Publication citations

Additional files

Editorial Notes

01/12/2016: The study was submitted for registration on 03/07/2013 before the recruitment of the first participant. Following this submission, there were no subsequent changes to the information as supplied in the study record. The recruitment started on 23/07/2013, after the trialist applied for registration.