Point of Care Polymerase Chain Reaction (PCR) Diagnostics of Respiratory Tract Infections in General Practice

NCT06120153 | Active Not Recruiting

• 1 other identifier: POCPCRdiagnosticsRCT
• Study Type: interventional
• Target: 5,700
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will assess the effect and cost-effectiveness of the availability of point-of-care (POC) PCR testing, in respiratory tract infections (RTIs) in general practice, compared with usual care.

Conditions

Respiratory Tract Infections

Keywords

Point of care PCR; General Practice

Outcome Measures

Primary Outcomes (1)

• Reduction of respiratory tract infections (RTI) patients' re-contacts to General Practitioners

  The primary outcome measure is change in the number of re-contacts within a time period of 7 days from initial contact for each patient consulting with a clinic for a RTI in the intervention period compared to the control period. The re-contacts include any daytime contacts to general practice and are based on data from the national Danish registries. RTI patients may present themselves with symptoms often associated with RTI, e.g., fever, cough, sore throat etc., but it is up to the treating clinician to categorize patients as having a RTI. Each time period (i.e., intervention and control) consists of 7 weeks.

  2 x 7 weeks of trial = 14 weeks in total (exclusive crossover)

Secondary Outcomes (10)

• Change in number of hospital admission and deaths

  Within a time period of 14 days from initial contact for a respiratory tract infection

• Change in number of redeemed antibiotic prescriptions

  Within a time period of 7 days from initial contact for a respiratory tract infection

• Effect of POC PCR in general practice on patient satisfaction based on patient satisfaction questionnaires.

  On the initial contact for RTI (baseline)

• Effect of POC PCR in general practice on GP satisfaction based on GP satisfaction questionnaires

  At the end of trial (through study completion, an average of 23 weeks)

• Total treatment costs 28 days from the initial contact for RTIs based on data from Danish national registers

  28 days from the initial contact for RTI

Study Arms (2)

POC PCR-test device

ACTIVE COMPARATOR

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.

Diagnostic Test: POC PCR-test device

Standard testing

NO INTERVENTION

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.

Interventions

POC PCR-test device DIAGNOSTIC_TEST

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.

POC PCR-test device

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• GP clinics are eligible for participation when they have a clinic provider number ("ydernummer").
• 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

You may not qualify if:

• \- Questionnaire data of participants below 15 years

Sponsors & Collaborators

• University of Southern Denmark: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark

Odense C, 5000, Denmark

Location

Related Publications (10)

• 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.

  PMID: 25650863 BACKGROUND

• Vedsted P OF. Almen praksis' funktion og roller. 1 ed. Ehrenreich B MR, Vedsted P, editor. København: Munksgaard; 2011.

  BACKGROUND

• 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.

  PMID: 32497279 BACKGROUND

• 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.

  PMID: 33496033 BACKGROUND

• Organization. WH. Global action plan on antimicrobial resistance. Geneva:. World Health Organization; 2015.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25791983 BACKGROUND

• Foundation. ER. EQ-5D-Y User Guide. 2020.

  BACKGROUND

• 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.

  PMID: 21898916 BACKGROUND

• 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.

  PMID: 40921063 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Jens Søndergaard, MD, PhD, GP

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-blinded cluster randomized cross-over trial

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: November 7, 2023
• Study Start: October 30, 2023
• Primary Completion: March 22, 2026
• Study Completion: March 22, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)