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

This study has been completed.
Sponsor:
Collaborators:
Vastra Gotaland Region
Strama - the Swedish strategic programme against antibiotic resistance.
Capio Research Foundation
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT01133782
First received: May 28, 2010
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Acute Respiratory Tract Infection
Procedure: Access to diagnostic test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 406
Study Start Date: October 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133782

Locations
Sweden
Department of Infectious Diseases, Sahlgrenska University Hospital
Gothenburg, Sweden, se-41685
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Strama - the Swedish strategic programme against antibiotic resistance.
Capio Research Foundation
  More Information

No publications provided by Göteborg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johan Westin, University of Gothenburg, Dept of Infectious Diseases/Clinical Virology
ClinicalTrials.gov Identifier: NCT01133782     History of Changes
Other Study ID Numbers: luftvagsPCR-01
Study First Received: May 28, 2010
Last Updated: May 28, 2010
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014