Testing for respiratory infections using quick PCR methods in general practice
A Cluster-randomized Trial of Point-of-care PCR Diagnostics of Respiratory Tract Infections in General Practice
This study is testing a quick testing method for respiratory infections in GP clinics to see if it helps doctors diagnose patients better and save on healthcare costs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5700 (estimated) |
| Ages | 0 Years and up |
| Sex | All |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 1 site (Odense C) |
| Trial ID | NCT06120153 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and cost-efficiency of point-of-care (POC) PCR testing for diagnosing respiratory tract infections (RTIs) in general practice compared to standard care. By implementing POC PCR testing, the study aims to improve diagnostic accuracy, reduce unnecessary re-contacts, and optimize antibiotic prescribing practices. The research will involve GP clinics that meet specific criteria and will collect data from patients and healthcare providers to assess the impact of this diagnostic approach on patient outcomes and healthcare costs.
Who should consider this trial
Good fit: Ideal candidates include any patients exhibiting symptoms of respiratory tract infections, regardless of age or background, as long as their GP deems the POC PCR testing clinically relevant.
Not a fit: Patients under 15 years old will not benefit from this study as their questionnaire data will not be collected.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and better management of respiratory infections, ultimately reducing unnecessary antibiotic use and improving patient care.
How similar studies have performed: Previous studies have shown that POC PCR testing in primary care can significantly improve antibiotic prescribing patterns, indicating a promising approach for this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria:
* 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
Exclusion criteria:
- Questionnaire data of participants below 15 years
Where this trial is running
Odense C
- Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark — Odense C, Denmark (Recruiting)
Study contacts
- Principal investigator: Jens Søndergaard, MD, PhD, GP — University of Southern Denmark
- Study coordinator: Line Maria Simonsen, PhD
- Email: lsimonsen@health.sdu.dk
- Phone: 65504213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.