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

NCT06120153 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5700

Last updated 2025-07-31

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Roche Diagnostics GmbH

    collaborator INDUSTRY
  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Jens Søndergaard, MD, PhD, GP · University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2026-03-22
Completion
2026-03-22

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06120153 on ClinicalTrials.gov