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

Acute Respiratory Tract Infection Clinical Trial

— luftvagsPCR  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133782
• Other study ID #: luftvagsPCR-01
• Status: Completed
• Phase: N/A
• First received: May 28, 2010
• Last updated: May 28, 2010
• Start date: October 2006
• Est. completion date: April 2009

Study information

• Verified date: October 2006
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Procedure:
• Access to diagnostic test
Randomization to receive a result of diagostic procedure the following day.

Locations

Country	Name	City	State
Sweden	Department of Infectious Diseases, Sahlgrenska University Hospital	Gothenburg

Sponsors (4)

Lead Sponsor	Collaborator
Göteborg University	Capio Research Foundation, Strama - the Swedish strategic programme against antibiotic resistance., Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic treatment prescriped at initial visit	Antibiotic prescriptions are measured as an outcome of the diagnostic procedure tested.	Within 2 days of initial visit	No
Secondary	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	No