NCT01133782

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Göteborg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Acute Respiratory Tract Infection

Interventions

Type	Name	Description
PROCEDURE	Access to diagnostic test	Randomization to receive a result of diagostic procedure the following day.

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2010-05-31
• Last updated: 2010-05-31

Locations

1 site across 1 country: Sweden