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

Göteborg University

Status: Completed

Conditions: Acute Respiratory Tract Infection

Treatments: Procedure: Access to diagnostic test

Study type: Interventional

Funder types: Other

Identifiers

NCT01133782

luftvagsPCR-01

Details and patient eligibility

About

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.

Enrollment: 406 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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406 participants in 2 patient groups

Rapid result

Experimental group

Description:

Result of diagnostic PCR panel provided the following day

Treatment:

Procedure: Access to diagnostic test

Delayed result

No Intervention group

Description:

Result of dagnostic PCR panel provided within 10+/-2 days at follow-up visit.