Clinical Application of PCR-based Diagnosis of Community-onset Viral Respiratory Infections. (luftvagsPCR)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
- Antibiotic treatment prescriped at initial visit [ Time Frame: Within 2 days of initial visit ] [ Designated as safety issue: No ]Antibiotic prescriptions are measured as an outcome of the diagnostic procedure tested.
- Antibiotic treatment prescribed or reported at follow-up visit [ Time Frame: 10+/-2 days ] [ Designated as safety issue: No ]Antibiotic prescriptions at follow visit are measured as an outcome of the diagnostic procedure tested.
|Study Start Date:||October 2006|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Experimental: Rapid result
Result of diagnostic PCR panel provided the following day
Procedure: Access to diagnostic test
Randomization to receive a result of diagostic procedure the following day.
No Intervention: Delayed result
Result of dagnostic PCR panel provided within 10+/-2 days at follow-up visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133782
|Department of Infectious Diseases, Sahlgrenska University Hospital|
|Gothenburg, Sweden, se-41685|