Respiratory Tract InfectionsNCT06120153
Point of Care Polymerase Chain Reaction (PCR) Diagnostics of Respiratory Tract Infections in General Practice
A study testing POC PCR-test device in people with Respiratory Tract Infections, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- POC PCR-test device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,700 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Oct 2023to 22 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Questionnaire data of participants below 15 years
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit of General Practice, Dept. of Public Health, University of Southern Denmark
Odense C, 5000
About this study
Official title: A Cluster-randomized Trial of Point-of-care PCR Diagnostics of Respiratory Tract Infections in General Practice
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.
Read the detailed description
Background: Respiratory tract infections (RTIs) are frequent reasons for medical consultations and diagnostic accuracy is important to ensure appropriate treatment. It is important for the quality of the healthcare system that patients are diagnosed as fast as possible and that the GP and the patient are reassured about the diagnostic accuracy. If not, the patient may be unnecessarily concerned and contact health services again.
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
- Respiratory Tract Infections
- Being tested
- POC PCR-test device
- Keywords
- Point of care PCR, General Practice
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC PCR-test deviceDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 x 7 weeks of trial = 14 weeks in total (exclusive crossover)
Secondary outcomes (10)
Change in number of hospital admission and deaths
Change in number of hospital admission and deaths in the intervention period compared to the control period. Hospital admission and deaths are based on data from the national Danish registries.
Measured: Within a time period of 14 days from initial contact for a respiratory tract infection
Change in number of redeemed antibiotic prescriptions
Change in number of redeemed antibiotic prescriptions in the intervention period compared to the control period. The number of prescriptions are based on data from the national Danish registries.
Measured: 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.
Effect of POC PCR in general practice on patient satisfaction based on patient satisfaction questionnaires. Satisfaction is measured on a five-point likert scale, ranging from "strongly disagree" to "strongly agree".
Measured: On the initial contact for RTI (baseline)
Effect of POC PCR in general practice on GP satisfaction based on GP satisfaction questionnaires
Effect of POC PCR in general practice on GP satisfaction based on GP satisfaction questionnaires aimed to be on five point likert scales, but adapted on basis of interviews with participating healthcare personnel. The scales will be ranging from "Strongly disagree" to "Strongly agree".
Measured: 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
The Effect of POC PCR in general practice on healthcare costs based on data from Danish national registers.
Measured: 28 days from the initial contact for RTI
Productivity costs based on WPAI-GH-questionnaires
The effect of POC PCR in general practice on productivity loss. Measured by (an adjusted version of) Work Productivity and Activity Impairment General Health(WPAI-GH). The WPAI-GH consist of six questions: 1=currently employed; 2=hour missed due to health problems, 3=hours missed other reasons, 4= hours actually worked; 5=degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6= degree health affected productivity in regular unpaid activity (0-10 VAS). Answers from the six questions will be combined to estimate the value of productivity loss.
Measured: Productivity loss will be measured at baseline (day of the initial visit to the GP for RTI), as well as at day 7, 14 and day 28 after the initial visit.
Health-related quality of life (EQ-5D-5L)
The effect of POC PCR in general practice on Health-related-Quality-of-Life (HRQoL) Health-related-Quality-of-life is assessed with the "EuroQol, 5 Dimensions with 5 Levels" instrument (EQ-5D-5L) with range 5-25 and higher values indicating higher quality of life. The Danish version of the EQ-5D-5L will be used to assess health status in five dimensions (mobility, self-care, daily activities, pain/unease, and anxiety/depression) with five levels of severity (no problems, slight problems, moderate problems, severe problems, and either extreme problems or unable to perform activity).
Measured: HRQoL will be measured at baseline (day of the initial visit to the GP for RTI), as well as at day 7, 14 and day 28 after the initial visit.
Cost-effectiveness
Cost-effectiveness of POC PCR in general practice Cost effectiveness will be measured according to Incremental cost-effectiveness ratio (ICER).
Change in cost-effectiveness will be calculated as differences in mean costs divided by the difference in mean number of recontacts.
For costing, a limited societal perspective will be assumed. Healthcare costs and travel costs will be collected from Danish national registries and productivity loss will assess based on questionnaire data.
Measured: Within 28 days
Cost-utility
Cost-utility of POC PCR in general practice. Cost-utility will be measured according to Incremental cost-effectiveness ratio (ICER).
Change in cost-utility Cost-utility will be measured by the EuroQol, 5 Dimensions with 5 Levels instrument (EQ-5D-5L) and Danish value sets will be used to calculate Quality-adjusted-life-years (QALYs). QALYs range from 0 to 1, where 0 means dead and 1 means perfect health. The ICER will be calculated as the differences in mean cost divided by the difference in mean QALYs.
For costing, a limited societal perspective will be assumed. Healthcare costs and travel costs will be collected from Danish national registries and productivity loss will assess based on questionnaire data.
Measured: Within 28 days
Qualitative process evaluation
In line with MRC-guidelines, a qualitative assessment and explanation of the factors that could promote or inhibit the uptake of the intervention among health professionals involved in the trial.
The evaluation focuses on the experience and use of the POC PCR-test in the clinics.
Methods: 10 pre-intervention interviews with GPs and practice members and 10 post-intervention interviews with GPs and practice members are conducted. Observation studies in 5 clinics before and during trial is conducted. Approximately 15 interviews with patients are conducted.
Measured: Prior and during the 14 weeks study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start30 Oct 2023
- Primary completion22 Mar 2026 (estimated)
- Study completion22 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Non-blinded cluster randomized cross-over trial
- Masking
- None (open label)
- Enrolment
- 5,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Jens Søndergaard, MD, PhD, GP, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120153
- Sponsor's protocol ID
- POCPCRdiagnosticsRCT
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25650863Vedsted 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.
PubMed 32497279Pottegard 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.
PubMed 33496033Organization. WH. Global action plan on antimicrobial resistance. Geneva:. World Health Organization; 2015.
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.
PubMed 25791983Foundation. 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.
PubMed 21898916Balasubramaniam 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.
PubMed 40921063
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomized Trial of Point-of-care PCR Diagnostics of Respiratory Tract Infections in General Practice
- ClinicalTrials.gov ID
- NCT06120153
- Acronym / sponsor ID
- POCPCRdiagnosticsRCT
- Conditions
- Respiratory Tract Infections
- Keywords
- Point of care PCR, General Practice
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,700 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 22 Mar 2026 (estimated)
- Study completion
- 22 Mar 2026 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Respiratory tract infections (RTIs) are frequent reasons for medical consultations and diagnostic accuracy is important to ensure appropriate treatment. It is important for the quality of the healthcare system that patients are diagnosed as fast as possible and that the GP and the patient are reassured about the diagnostic accuracy. If not, the patient may be unnecessarily concerned and contact health services again.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded cluster randomized cross-over trial
| Arm | Type | Receives |
|---|---|---|
| POC PCR-test device | Active comparator | Diagnostic Test: POC PCR-test deviceIn 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. |
| 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. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Questionnaire data of participants below 15 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POC PCR-test deviceThe 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. | Diagnostic test | POC PCR-test device |
Primary outcome
Reduction of respiratory tract infections (RTI) patients' re-contacts to General Practitioners
Time frame: 2 x 7 weeks of trial = 14 weeks in total (exclusive crossover)
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.
10 secondary outcomes
Change in number of hospital admission and deaths
Time frame: Within a time period of 14 days from initial contact for a respiratory tract infection
Change in number of redeemed antibiotic prescriptions
Time frame: 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.
Time frame: On the initial contact for RTI (baseline)
Effect of POC PCR in general practice on GP satisfaction based on GP satisfaction questionnaires
Time frame: 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
Time frame: 28 days from the initial contact for RTI
Productivity costs based on WPAI-GH-questionnaires
Time frame: Productivity loss will be measured at baseline (day of the initial visit to the GP for RTI), as well as at day 7, 14 and day 28 after the initial visit.
Health-related quality of life (EQ-5D-5L)
Time frame: HRQoL will be measured at baseline (day of the initial visit to the GP for RTI), as well as at day 7, 14 and day 28 after the initial visit.
Cost-effectiveness
Time frame: Within 28 days
Cost-utility
Time frame: Within 28 days
Qualitative process evaluation
Time frame: Prior and during the 14 weeks study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 25650863Jose 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.
- BackgroundVedsted P OF. Almen praksis' funktion og roller. 1 ed. Ehrenreich B MR, Vedsted P, editor. København: Munksgaard; 2011.
- Background: PubMed 32497279Cohen 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.
- Background: PubMed 33496033Pottegard 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.
- BackgroundOrganization. WH. Global action plan on antimicrobial resistance. Geneva:. World Health Organization; 2015.
- BackgroundAI 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: PubMed 25791983Moore 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.
- BackgroundFoundation. ER. EQ-5D-Y User Guide. 2020.
- Background: PubMed 21898916Thygesen 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.
- Derived from this study: PubMed 40921063Balasubramaniam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Søndergaard, MD, PhD, GP principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POC PCR-test device in people with Respiratory Tract Infections, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of respiratory tract infections (RTI) patients' re-contacts to General Practitioners (time frame: 2 x 7 weeks of trial = 14 weeks in total (exclusive crossover)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06120153, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.