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

NCT01133782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2010-05-31

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Tract Infection

Interventions

PROCEDURE

Access to diagnostic test

Randomization to receive a result of diagostic procedure the following day.

Sponsors & Collaborators

  • Vastra Gotaland Region

    collaborator OTHER_GOV

  • Strama - the Swedish strategic programme against antibiotic resistance.

    collaborator UNKNOWN

  • Capio Research Foundation

    collaborator OTHER

  • Göteborg University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01133782 on ClinicalTrials.gov