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AuthorBates, Janine
AuthorFrancis, Nick A
AuthorWhite, Patrick
AuthorGillespie, David
AuthorThomas-Jones, Emma
AuthorBreen, Rachel
AuthorKirby, Nigel
AuthorHood, Kerry
AuthorGal, Micaela
AuthorPhillips, Rhiannon
AuthorNaik, Gurudutt
AuthorCals, Jochen
AuthorLlor, Carl
AuthorMelbye, Hasse
AuthorWootton, Mandy
AuthorRiga, Evgenia
AuthorCochrane, Ann
AuthorHowe, Robin
AuthorFitzsimmons, Deborah
AuthorSewell, Bernadette
AuthorAlam, Mohammed Fasihul
AuthorButler, Christopher C
Available date2017-11-28T08:34:37Z
Publication Date2017-09-01
Publication NameTrials
Identifierhttp://dx.doi.org/10.1186/s13063-017-2144-8
CitationBates et al. (2017). General practitioner use of a C-reactive protein point-of-care test to help target antibiotic prescribing in patients with acute exacerbations of chronic obstructive pulmonary disease (the PACE study): study protocol for a randomised controlled trial. Trials. 8:442
URIhttp://hdl.handle.net/10576/5809
AbstractMost patients presenting with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in primary care are prescribed an antibiotic, which may not always be appropriate and may cause harm. C-reactive protein (CRP) is an acute-phase biomarker that can be rapidly measured at the point of care and may predict benefit from antibiotic treatment in AECOPD. It is not clear whether the addition of a CRP point-of-care test (POCT) to clinical assessment leads to a reduction in antibiotic consumption without having a negative impact on COPD health status. This is a multicentre, individually randomised controlled trial (RCT) aiming to include 650 participants with a diagnosis of AECOPD in primary care. Participants will be randomised to be managed according to usual care (control) or with the addition of a CRP POCT to guide antibiotic prescribing. Antibiotic consumption for AECOPD within 4 weeks post randomisation and COPD health status (total score) measured by the Clinical COPD Questionnaire (CCQ) at 2 weeks post randomisation will be co-primary outcomes. Primary analysis (by intention-to-treat) will determine differences in antibiotic consumption for superiority and COPD health status for non-inferiority. Secondary outcomes include: COPD health status, CCQ domain scores, use of other COPD treatments (weeks 1, 2 and 4), EQ-5D utility scores (weeks 1, 2 and 4 and month 6), disease-specific, health-related quality of life (HRQoL) at 6 months, all-cause antibiotic consumption (antibiotic use for any condition) during first 4 weeks post randomisation, total antibiotic consumption (number of days during first 4 weeks of antibiotic consumed for AECOPD/any reason), antibiotic prescribing at the index consultation and during following 4 weeks, adverse effects over the first 4 weeks, incidence of pneumonia (weeks 4 and 6 months), health care resource use and cost comparison over the 6 months following randomisation. Prevalence and resistance profiles of bacteria will be assessed using throat and sputum samples collected at baseline and 4-week follow-up. A health economic evaluation and qualitative process evaluation will be carried out. If shown to be effective (i.e. leads to a reduction in antibiotic use with no worse COPD health status), the use of the CRP POCT could lead to better outcomes for patients with AECOPD and help reduce selective pressures driving the development of antimicrobial resistance. PACE will be one of the first studies to evaluate the cost-effectiveness of a POCT biomarker to guide clinical decision-making in primary care on patient-reported outcomes, antibiotic prescribing and antibiotic resistance for AECOPD. ISRCTN registry, ID: ISRCTN24346473 . Registered on 20 August 2014.
Languageen
PublisherBioMed Central
SubjectAcute exacerbation
Antibiotic resistance
C-reactive protein (CRP)
Chronic obstructive pulmonary disease
Cost-effectiveness
Near-patient testing
Point-of-care test
Primary care
Rationalising antibiotic prescribing
Resistance
TitleGeneral practitioner use of a C-reactive protein point-of-care test to help target antibiotic prescribing in patients with acute exacerbations of chronic obstructive pulmonary disease (the PACE study): study protocol for a randomised controlled trial.
TypeArticle
Issue Number442
Volume Number18
ESSN1745-6215
dc.accessType Open Access


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