Effect of point-of-care C-reactive protein testing on antibiotic prescription in febrile patients attending primary care in Thailand and Myanmar: an open-label, randomised, controlled trial

IntroductionC-reactive protein (CRP), a biomarker of infection, has been used widely in high-income settings to guide antibiotic treatment in patients presenting with respiratory illnesses in primary care. Recent trials in low- and middle-income countries showed that CRP testing could safely reduce antibiotic use in patients with non-severe acute respiratory infections (ARIs) and fever in primary care. The studies, however, were conducted in a research-oriented context, with research staff closely monitoring healthcare behaviour thus potentially influencing healthcare workers’ prescribing practices. For policy-makers to consider wide-scale roll-out, a pragmatic implementation study of the impact of CRP point of care (POC) testing in routine care is needed.Methods and analysisA pragmatic, cluster-randomised controlled trial, with two study arms, consisting of 24 commune health centres (CHC) in the intervention arm (provision of CRP tests with additional healthcare worker guidance) and 24 facilities acting as controls (routine care). Comparison between the treatment arms will be through logistic regression, with the treatment assignment as a fixed effect, and the CHC as a random effect. With 48 clusters, an average of 10 consultations per facility per week will result in approximately 520 over 1 year, and 24 960 in total (12 480 per arm). We will be able to detect a reduction of 12% to 23% or more in immediate antibiotic prescription as a result of the CRP POC intervention. The primary endpoint is the proportion of patient consultations for ARI resulting in immediate antibiotic prescription. Secondary endpoints include the proportion of all patients receiving an antibiotic prescription regardless of ARI diagnosis, frequency of re-consultation, subsequent antibiotic use when antibiotics are not prescribed, referral and hospitalisation.Ethics and disseminationThe study protocol was approved by the Oxford University Tropical Research Ethics Committee (OxTREC, Reference: 53–18), and the ethical committee of the National Hospital for Tropical Diseases in Vietnam (Reference:07/HDDD-NDTW/2019). Results from this study will be disseminated via meetings with stakeholders, conferences and publications in peer-reviewed journals. Authorship and reporting of this work will follow international guidelines.Trial registration detailsNCT03855215; Pre-results.

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Point-of-care C-reactive protein to assist in primary care management of children with suspected non-serious lower respiratory tract infection: a randomised controlled trial

BJGP Open ◽

10.3399/bjgpopen18x101600 ◽

2018 ◽

Vol 2 (3) ◽

pp. bjgpopen18X101600 ◽

Cited By ~ 4

Author(s):

Marjolein JC Schot ◽

Ann Van den Bruel ◽

Berna DL Broekhuizen ◽

Jochen WL Cals ◽

Eveline A Noteboom ◽

...

Keyword(s):

General Practice ◽

Randomised Controlled Trial ◽

Respiratory Tract ◽

Lower Respiratory Tract ◽

Antibiotic Prescription ◽

Point Of Care ◽

Controlled Trial ◽

C Reactive Protein ◽

Reactive Protein ◽

Randomised Controlled

BackgroundOverprescription of antibiotics for lower respiratory tract infections (LRTIs) in children is common, partly due to diagnostic uncertainty, in which case the addition of point-of-care (POC) C-reactive protein (CRP) testing can be of aid.AimTo assess whether use of POC CRP by the GP reduces antibiotic prescriptions in children with suspected non-serious LRTI.Design & settingAn open, pragmatic, randomised controlled trial in daytime general practice and out-of-hours services.MethodChildren between 3 months and 12 years of age with acute cough and fever were included and randomised to either use of POC CRP or usual care. Antibiotic prescription rates were measured and compared between groups using generalising estimating equations.ResultsThere was no statistically significant reduction in antibiotic prescriptions in the GP use of CRP group (30.9% versus 39.4%; odds ratio [OR] 0.6; 95% confidence interval [CI] = 0.29 to 1.23). Only the estimated severity of illness was related to antibiotic prescription. Forty-six per cent of children had POC CRP levels <10mg/L.ConclusionIt is still uncertain whether POC CRP measurement in children with non-serious respiratory tract infection presenting to general practice can reduce the prescription of antibiotics. Until new research provides further evidence, POC CRP measurement in these children is not recommended.

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Faculty Opinions recommendation of Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.737097923.793569009 ◽

2019 ◽

Author(s):

Allen Cheng

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Open Label ◽

Influenza Like Illness ◽

Randomised Controlled ◽

Pragmatic Randomised Controlled Trial

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Cost-Effectiveness Analysis of the Use of Point-of-Care C-Reactive Protein Testing to Reduce Antibiotic Prescribing in Primary Care

Antibiotics ◽

10.3390/antibiotics7040106 ◽

2018 ◽

Vol 7 (4) ◽

pp. 106 ◽

Cited By ~ 6

Author(s):

Emily Holmes ◽

Sharman Harris ◽

Alison Hughes ◽

Noel Craine ◽

Dyfrig Hughes

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Respiratory Tract ◽

Clinical Guidelines ◽

Antibiotic Prescription ◽

Point Of Care ◽

Cost Effective ◽

Routine Practice ◽

C Reactive Protein ◽

Reactive Protein

More appropriate and measured use of antibiotics may be achieved using point-of-care (POC) C-reactive protein (CRP) testing, but there is limited evidence of cost-effectiveness in routine practice. A decision analytic model was developed to estimate the cost-effectiveness of testing, compared with standard care, in adults presenting in primary care with symptoms of acute respiratory tract infection (ARTI). Analyses considered (1) pragmatic use of testing, reflective of routine clinical practice, and (2) testing according to clinical guidelines. Threshold and scenario analysis were performed to identify cost-effective scenarios. In patients with symptoms of ARTI and based on routine practice, the incremental cost-effectiveness ratios of CRP testing were £19,705 per quality-adjusted-life-year (QALY) gained and £16.07 per antibiotic prescription avoided. Following clinical guideline, CRP testing in patients with lower respiratory tract infections (LRTIs) cost £4390 per QALY gained and £9.31 per antibiotic prescription avoided. At a threshold of £20,000 per QALY, the probabilities of POC CRP testing being cost-effective were 0.49 (ARTI) and 0.84 (LRTI). POC CRP testing as implemented in routine practice is appreciably less cost-effective than when adhering to clinical guidelines. The implications for antibiotic resistance and Clostridium difficile infection warrant further investigation.

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