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Point of care testing for urinary tract infection in primary care (POETIC): protocol for a randomised controlled trial of the clinical and cost effectiveness of FLEXICULT (TM) informed management of uncomplicated UTI in primary care

Point of care testing for urinary tract infection in primary care (POETIC): protocol for a randomised controlled trial of the clinical and cost effectiveness of FLEXICULT (TM) informed management of uncomplicated UTI in primary care
Point of care testing for urinary tract infection in primary care (POETIC): protocol for a randomised controlled trial of the clinical and cost effectiveness of FLEXICULT (TM) informed management of uncomplicated UTI in primary care
Background

Urinary tract infections (UTI) are the most frequent bacterial infection affecting women and account for about 15% of antibiotics prescribed in primary care. However, some women with a UTI are not prescribed antibiotics or are prescribed the wrong antibiotics, while many women who do not have a microbiologically confirmed UTI are prescribed antibiotics. Inappropriate antibiotic prescribing unnecessarily increases the risk of side effects and the development of antibiotic resistance, and wastes resources.

POETIC is a randomised controlled trial of a Point Of Care Test (POCT) (Flexicult™) guided UTI management strategy for use in primary care, which may help General Practitioners more effectively decide both whether or not to prescribe antibiotics, and if so, to select the most appropriate antibiotic.
Methods/design

614 adult female patients will be recruited from four primary care research networks (Wales, England, Spain, the Netherlands) and individually randomised to either POCT guided care or the guideline-informed `standard care’ arm. Urine and stool samples (where possible) will be obtained at presentation (day 1) and two weeks later for microbiological analysis. All participants will be followed up on the course of their illness and their quality of life, using a 2 week self-completed symptom diary. At 3 months, a primary care notes review will be conducted for evidence of further evidence of treatment failures, recurrence, complications, hospitalisations and health service costs.

The primary objective is to compare appropriate antibiotic use on day 3 between the POCT and standard care arms using multi-level logistic regression to produce an odds ratio and associated 95% confidence interval. Costs of the two management approaches will be assessed in terms of the primary outcome.
Discussion

Although the Flexicult™ POCT is used in some countries in routine primary care, it’s clinical and cost effectiveness has never been evaluated in a randomised clinical trial. If shown to be effective, the use of this POCT could benefit individual sufferers and provide evidence for health care authorities to develop evidence based policies to combat the spread and impact of the unprecedented rise of infections caused by antibiotic resistant bacteria in Europe.
Trial registration number

ISRCTN65200697 (Registered 10 September 2013).
1471-2296
Bates, Janine
290a69e6-4f81-4dbe-b270-30e4155ca576
Thomas-Jones, Emma
ea15d5ac-8232-4823-ab40-17bec0968520
Pickles, Timothy
d6ba6e68-3426-407e-93b2-04b588365fe3
Kirby, Nigel
f096d265-c00e-42e0-8cd8-fb5ab470f513
Gal, Micaela
2d266726-f171-4a55-a381-29c5a2e42ec1
Bongard, Emily
498cda67-5b1a-4f3a-98f1-9c2b01c48410
Hood, Kerenza
af7cf839-ca85-4ea9-83c3-3dd31be88b32
Francis, Nicolas
9b610883-605c-4fee-871d-defaa86ccf8e
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Rumsby, Kate
2002ee8a-32ac-4119-869d-ed35164c3b51
Llor, Carlos
c2d9c72a-0a65-445f-9706-0413910f5449
Burgman, Curt
b514d3e8-ff22-4cfc-be58-90df032e9c43
Verheij, Theo
772e019f-486f-4a64-9260-bac6446a85d2
Cohen, David
8bd9a96d-519b-463a-a69f-8883fd3acbdb
Wootton, Mandy
4179ab83-aebf-4b01-9203-f067b2bd7d81
Howe, Robin
e02d3c72-421b-4396-bf99-392e8847247f
Butler, Christopher C.
8bf4cace-c34a-4b65-838f-29c2be91e434
Bates, Janine
290a69e6-4f81-4dbe-b270-30e4155ca576
Thomas-Jones, Emma
ea15d5ac-8232-4823-ab40-17bec0968520
Pickles, Timothy
d6ba6e68-3426-407e-93b2-04b588365fe3
Kirby, Nigel
f096d265-c00e-42e0-8cd8-fb5ab470f513
Gal, Micaela
2d266726-f171-4a55-a381-29c5a2e42ec1
Bongard, Emily
498cda67-5b1a-4f3a-98f1-9c2b01c48410
Hood, Kerenza
af7cf839-ca85-4ea9-83c3-3dd31be88b32
Francis, Nicolas
9b610883-605c-4fee-871d-defaa86ccf8e
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Rumsby, Kate
2002ee8a-32ac-4119-869d-ed35164c3b51
Llor, Carlos
c2d9c72a-0a65-445f-9706-0413910f5449
Burgman, Curt
b514d3e8-ff22-4cfc-be58-90df032e9c43
Verheij, Theo
772e019f-486f-4a64-9260-bac6446a85d2
Cohen, David
8bd9a96d-519b-463a-a69f-8883fd3acbdb
Wootton, Mandy
4179ab83-aebf-4b01-9203-f067b2bd7d81
Howe, Robin
e02d3c72-421b-4396-bf99-392e8847247f
Butler, Christopher C.
8bf4cace-c34a-4b65-838f-29c2be91e434

Bates, Janine, Thomas-Jones, Emma, Pickles, Timothy, Kirby, Nigel, Gal, Micaela, Bongard, Emily, Hood, Kerenza, Francis, Nicolas, Little, Paul, Moore, Michael, Rumsby, Kate, Llor, Carlos, Burgman, Curt, Verheij, Theo, Cohen, David, Wootton, Mandy, Howe, Robin and Butler, Christopher C. (2014) Point of care testing for urinary tract infection in primary care (POETIC): protocol for a randomised controlled trial of the clinical and cost effectiveness of FLEXICULT (TM) informed management of uncomplicated UTI in primary care. BMC Family Practice, 15, [187]. (doi:10.1186/s12875-014-0187-4).

Record type: Article

Abstract

Background

Urinary tract infections (UTI) are the most frequent bacterial infection affecting women and account for about 15% of antibiotics prescribed in primary care. However, some women with a UTI are not prescribed antibiotics or are prescribed the wrong antibiotics, while many women who do not have a microbiologically confirmed UTI are prescribed antibiotics. Inappropriate antibiotic prescribing unnecessarily increases the risk of side effects and the development of antibiotic resistance, and wastes resources.

POETIC is a randomised controlled trial of a Point Of Care Test (POCT) (Flexicult™) guided UTI management strategy for use in primary care, which may help General Practitioners more effectively decide both whether or not to prescribe antibiotics, and if so, to select the most appropriate antibiotic.
Methods/design

614 adult female patients will be recruited from four primary care research networks (Wales, England, Spain, the Netherlands) and individually randomised to either POCT guided care or the guideline-informed `standard care’ arm. Urine and stool samples (where possible) will be obtained at presentation (day 1) and two weeks later for microbiological analysis. All participants will be followed up on the course of their illness and their quality of life, using a 2 week self-completed symptom diary. At 3 months, a primary care notes review will be conducted for evidence of further evidence of treatment failures, recurrence, complications, hospitalisations and health service costs.

The primary objective is to compare appropriate antibiotic use on day 3 between the POCT and standard care arms using multi-level logistic regression to produce an odds ratio and associated 95% confidence interval. Costs of the two management approaches will be assessed in terms of the primary outcome.
Discussion

Although the Flexicult™ POCT is used in some countries in routine primary care, it’s clinical and cost effectiveness has never been evaluated in a randomised clinical trial. If shown to be effective, the use of this POCT could benefit individual sufferers and provide evidence for health care authorities to develop evidence based policies to combat the spread and impact of the unprecedented rise of infections caused by antibiotic resistant bacteria in Europe.
Trial registration number

ISRCTN65200697 (Registered 10 September 2013).

Full text not available from this repository.

More information

Accepted/In Press date: 4 November 2014
e-pub ahead of print date: 25 November 2014

Identifiers

Local EPrints ID: 436379
URI: http://eprints.soton.ac.uk/id/eprint/436379
ISSN: 1471-2296
PURE UUID: 5953fe7c-80dc-40c3-b7fa-daf316e65f4c
ORCID for Nicolas Francis: ORCID iD orcid.org/0000-0001-8939-7312
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509
ORCID for Kate Rumsby: ORCID iD orcid.org/0000-0002-8573-3718

Catalogue record

Date deposited: 09 Dec 2019 17:30
Last modified: 27 Jan 2020 13:59

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