Point of Care Polymerase Chain Reaction (PCR) Diagnostics of Respiratory Tract Infections in General Practice
NCT ID: NCT06120153
Last Updated: 2025-07-31
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
5700 participants
INTERVENTIONAL
2023-10-30
2026-03-22
Brief Summary
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Detailed Description
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Re-contacts are costly for society, but they may also be unsatisfactory to the patient and the clinician, because many re-contacts may indicate that tentative diagnosis or treatment were not successful and that in some cases the patient needs to contact health services again to get a sufficient answer or to be reassured that nothing is dangerous.
The introduction of POC PCR in primary care settings has demonstrated significant improvements in appropriate antibiotic prescription patterns in high income countries. In Denmark around 88 pct. of all prescription drugs are issued by general practice, as is the vast majority of the total antibiotics consumption in the healthcare system.
Antibiotic overuse may lead to microbial resistance and if the overall consumption is not reduced, infections with resistant bacteria will be a major problem for both patients and healthcare systems. Due to diagnostic uncertainty, GPs may in some situations prescribe antibiotics also in cases where the patient's symptoms are caused by a viral infection.
Further, if antibiotics are not prescribed, the patient may reconsult their GP or the out-of-hours services due to feelings of uncertainty.
Aims: The aim of the study is to evaluate the effect of POC PCR availability in general practice on 1) the number of re-contacts for patients with symptoms of RTIs, 2) the number of hospital admission, 3) deaths, 4) the number of redeemed antibiotic prescriptions, 5) costs, 6) health-related quality-of-life, 7) cost-effectiveness compared to usual care and 8) GP satisfaction.
Furthermore, a qualitative process evaluation will be conducted throughout the trial.
Methods This study is a cluster-randomized crossover, non-blinded superiority trial with a 1:1 allocation ratio. The procedure for randomization takes outset in the clinics' identification numbers as units. The trial consists of two periods of seven weeks (intervention and control). Care-as-usual is used as a comparator. The study is approved by the local regional ethics committee.
The effectiveness study and the cost-effectiveness study will be based on questionnaire data and data from the unique Danish national registries. Information from the different registers will be linked by the patients' Danish Personal Identification Number. Outcomes based on questionnaire data will be collected at baseline, day 7, 14 and day 28 after the initial visit.
GP and patient recruitment:
General practices in 4 out of 5 Danish regions have been invited to participate. GPs have been invited through a written letter and regional newsletters sent to all GPs in Denmark in March 2023. The GPs has been assigned at random to start as intervention or control practice. Based on sample size calculation, the goal was to include 100 GP clinics.
Each practice is asked to register all patients with symptoms of respiratory tract infections consecutively. The GPs are informed that it is entirely up to them and their clinical judgement to make a decision about whether or not they deem it relevant to employ the POC PCR-test device in the consultation with the patient.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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POC PCR-test device
In the seven-week intervention, the Point-of-Care PCR-testing device will be made available for approximate 50 clinics. Besides the general instructions on how to include patients, clinics in the intervention arm will be instructed that it is entirely up to the GP whether or not to use the PCR-testing device on each individual patient. In addition, no specific instructions on medical treatments or follow up procedures are made.
POC PCR-test device
The analysis will follow an intention-to-treat principle, that is, contacts in the intervention period will be analyzed as randomized, regardless of whether the POC PCR test was actually performed for a given contact. As sensitivity analysis, the data will be analyzed in a "per-protocol" spirit, defining the intervention at the contact level as a POC PCR test performed.
Standard testing
In the seven-week control period, the Point-of-Care PCR-testing device will not be available in approximately 50 clinics. Patients attended by the GP during control periods will receive treatment as usual. Like GPs in the intervention arm, GPs in the control arm are not actively encouraged to change their prescription patterns, but they must record data from patients with respiratory tract infections parallel to the intervention group.
No interventions assigned to this group
Interventions
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POC PCR-test device
The analysis will follow an intention-to-treat principle, that is, contacts in the intervention period will be analyzed as randomized, regardless of whether the POC PCR test was actually performed for a given contact. As sensitivity analysis, the data will be analyzed in a "per-protocol" spirit, defining the intervention at the contact level as a POC PCR test performed.
Eligibility Criteria
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Inclusion Criteria
* Any patient with symptoms of RTI independent of age, gender, socioeconomic factors are eligible for POC PCR testing, if the GP finds it clinically relevant.
* Questionnaire data will be collected from patients ≥15 years old, parents/caregivers to patients ˂15 years and GPs.
* Qualitative data will be collected from consenting patients and/or parents/caregivers to patients \<15 years and healthcare staff
Exclusion Criteria
0 Years
ALL
Yes
Sponsors
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Roche Diagnostics GmbH
INDUSTRY
University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Jens Søndergaard, MD, PhD, GP
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
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Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark
Odense C, , Denmark
Countries
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References
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Jose BP, Camargos PA, Cruz Filho AA, Correa Rde A. Diagnostic accuracy of respiratory diseases in primary health units. Rev Assoc Med Bras (1992). 2014 Nov-Dec;60(6):599-612. doi: 10.1590/1806-9282.60.06.021.
Vedsted P OF. Almen praksis' funktion og roller. 1 ed. Ehrenreich B MR, Vedsted P, editor. København: Munksgaard; 2011.
Cohen JF, Pauchard JY, Hjelm N, Cohen R, Chalumeau M. Efficacy and safety of rapid tests to guide antibiotic prescriptions for sore throat. Cochrane Database Syst Rev. 2020 Jun 4;6(6):CD012431. doi: 10.1002/14651858.CD012431.pub2.
Pottegard A, Olesen M, Christensen B, Christensen MB, Hallas J, Rasmussen L. Who prescribes drugs to patients: A Danish register-based study. Br J Clin Pharmacol. 2021 Jul;87(7):2982-2987. doi: 10.1111/bcp.14691. Epub 2021 Jan 25.
Mendelson M, Matsoso MP. The World Health Organization Global Action Plan for antimicrobial resistance. S Afr Med J. 2015 Apr 6;105(5):325. doi: 10.7196/samj.9644. No abstract available.
AI RNM. Improving efficiency in cluster-randomized study design and implementation: taking advantage of a crossover. Open Access Journal of Clinical Trials. 2014;6:11-5.
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.
Foundation. ER. EQ-5D-Y User Guide. 2020.
Thygesen LC, Daasnes C, Thaulow I, Bronnum-Hansen H. Introduction to Danish (nationwide) registers on health and social issues: structure, access, legislation, and archiving. Scand J Public Health. 2011 Jul;39(7 Suppl):12-6. doi: 10.1177/1403494811399956.
Balasubramaniam K, Simonsen LM, Kongstad LP, Thilsing T, Wehberg S, Hallas J, Sopina L, Nielsen JB, Overbeck G, Hvidt EA, Jarbol DE, Rasmussen TL, Sondergaard J. Evaluating the Effect of a Molecular Point-of-Care Test on Acute Respiratory Infections in General Practice: Protocol for a Cluster Randomized Trial. JMIR Res Protoc. 2025 Sep 8;14:e72842. doi: 10.2196/72842.
Other Identifiers
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POCPCRdiagnosticsRCT
Identifier Type: -
Identifier Source: org_study_id
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