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

This study has been completed.

Sponsor:

Collaborators:

Region Västra Götaland

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

Tracking Information
First Received Date ^ICMJE	May 28, 2010
Last Updated Date	May 28, 2010
Start Date ^ICMJE	October 2006
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 28, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: May 28, 2010)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Application of PCR-based Diagnosis of Community-onset Viral Respiratory Infections.
Official Title ^ICMJE	Not Provided
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Acute Respiratory Tract Infection
Intervention ^ICMJE	Procedure: Access to diagnostic test Randomization to receive a result of diagostic procedure the following day.
Study Arm (s)	Experimental: Rapid result Result of diagnostic PCR panel provided the following day Intervention: Procedure: Access to diagnostic test No Intervention: Delayed result Result of dagnostic PCR panel provided within 10+/-2 days at follow-up visit.
Publications *	Brittain-Long R, Westin J, Olofsson S, Lindh M, Andersson LM. Access to a polymerase chain reaction assay method targeting 13 respiratory viruses can reduce antibiotics: a randomised, controlled trial. BMC Med. 2011 Apr 26;9:44.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	406
Completion Date	April 2009
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01133782
Other Study ID Numbers ^ICMJE	luftvagsPCR-01
Has Data Monitoring Committee	No
Responsible Party	Johan Westin, University of Gothenburg, Dept of Infectious Diseases/Clinical Virology
Study Sponsor ^ICMJE	Göteborg University
Collaborators ^ICMJE	Region Västra Götaland Strama - the Swedish strategic programme against antibiotic resistance. Capio Research Foundation
Investigators ^ICMJE	Not Provided
Information Provided By	Göteborg University
Verification Date	October 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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