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

Sponsor

Göteborg University (Other)

Overall Status

Completed

CT.gov ID

NCT01133782

Collaborator

Vastra Gotaland Region (Other), Strama - the Swedish strategic programme against antibiotic resistance. (Other), Capio Research Foundation (Other)

406

Enrollment

Location

Arms

Duration (Months)

13.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Tract Infection	Procedure: Access to diagnostic test	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

406 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Antibiotic treatment prescriped at initial visit [Within 2 days of 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 [10+/-2 days]
Antibiotic prescriptions at follow visit are measured as an outcome of the diagnostic procedure tested.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01133782

Other Study ID Numbers:

luftvagsPCR-01

First Posted:

May 31, 2010

Last Update Posted:

May 31, 2010

Last Verified:

Oct 1, 2006

Additional relevant MeSH terms:

Infections

Respiratory Tract Infections

Study Results

No Results Posted as of May 31, 2010