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

Primary Purpose

Acute Respiratory Tract Infection

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Access to diagnostic test
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Infectious Diseases, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rapid result

Delayed result

Arm Description

Result of diagnostic PCR panel provided the following day

Result of dagnostic PCR panel provided within 10+/-2 days at follow-up visit.

Outcomes

Primary Outcome Measures

Antibiotic treatment prescriped at initial visit
Antibiotic prescriptions are measured as an outcome of the diagnostic procedure tested.

Secondary Outcome Measures

Antibiotic treatment prescribed or reported at follow-up visit
Antibiotic prescriptions at follow visit are measured as an outcome of the diagnostic procedure tested.

Full Information

First Posted
May 28, 2010
Last Updated
May 28, 2010
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region, Strama - the Swedish strategic programme against antibiotic resistance., Capio Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01133782
Brief Title
Clinical Application of PCR-based Diagnosis of Community-onset Viral Respiratory Infections.
Acronym
luftvagsPCR
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Tract Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid result
Arm Type
Experimental
Arm Description
Result of diagnostic PCR panel provided the following day
Arm Title
Delayed result
Arm Type
No Intervention
Arm Description
Result of dagnostic PCR panel provided within 10+/-2 days at follow-up visit.
Intervention Type
Procedure
Intervention Name(s)
Access to diagnostic test
Intervention Description
Randomization to receive a result of diagostic procedure the following day.
Primary Outcome Measure Information:
Title
Antibiotic treatment prescriped at initial visit
Description
Antibiotic prescriptions are measured as an outcome of the diagnostic procedure tested.
Time Frame
Within 2 days of initial visit
Secondary Outcome Measure Information:
Title
Antibiotic treatment prescribed or reported at follow-up visit
Description
Antibiotic prescriptions at follow visit are measured as an outcome of the diagnostic procedure tested.
Time Frame
10+/-2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Department of Infectious Diseases, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
se-41685
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21521505
Citation
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. doi: 10.1186/1741-7015-9-44.
Results Reference
derived

Learn more about this trial

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

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