Clinical Application of PCR-based Diagnosis of Community-onset Viral Respiratory Infections.

Study Overview
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Brief Summary
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Viral respiratory infections are common worldwide. It has been suggested that nucleic acid amplification tests, enabling a rapid etiologic diagnosis, may be useful in reducing antibiotic prescriptions rates. The objective of this study was to evaluate if access to a multiplex real-time PCR method would have an impact on antibiotic prescriptions for acute respiratory tract infections (ARTIs), in primary care. Adult patients with respiratory tract infections will be prospectively included. Nasopharyngeal and throat swabs will be analyzed with a multiplex real-time PCR method, targeting 13 viruses and two bacteria. Samples will be collected during the winter season (October-April). Patients will be open-label randomised to receive a rapid result (the following day) or a delayed result (after 10+/-2 days). The investigators are planning to include approximately 400 patients. Prescription of antibiotics will be measured at initial visit as well as at a follow-up visit 10+/-2 days later. Primary endpoint is antibiotic prescription in the acute phase (initial visit) and secondary endpoint antibiotic treatment (ongoing or initiated) at follow-up visit. The hypohesis is that access to a method with the ability of providing a rapid etiologic diagnosis of respiratory infections will affect the use of antibiotics in outpatient care of adult patients with ARTI.

Conditions
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Acute Respiratory Tract Infection

Intervention / Treatment
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* Procedure: Access to diagnostic test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older At least two of the following symptoms: coryza, congestion, sneezing, sore throat, odynophagi, cough, chest pain, shortness of breath or fever for which teh physician found no other explanation. Symptom duration of less than 14 days Exclusion Criteria: >14 days of symptoms confirmed bacterial infection Hospital acquired infection (>3days in hospital)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid result<br>Result of diagnostic PCR panel provided the following day | Procedure: Access to diagnostic test<br>* Randomization to receive a result of diagostic procedure the following day.<br>|
| No Intervention: Delayed result<br>Result of dagnostic PCR panel provided within 10+/-2 days at follow-up visit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic treatment prescriped at initial visit | Antibiotic prescriptions are measured as an outcome of the diagnostic procedure tested. | Within 2 days of initial visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic treatment prescribed or reported at follow-up visit | Antibiotic prescriptions at follow visit are measured as an outcome of the diagnostic procedure tested. | 10+/-2 days |