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

NCT ID: NCT01133782

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-04-30

Brief Summary

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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

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Conditions

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Acute Respiratory Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Rapid result

Result of diagnostic PCR panel provided the following day

Group Type EXPERIMENTAL

Access to diagnostic test

Intervention Type PROCEDURE

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

Delayed result

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Access to diagnostic test

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Strama - the Swedish strategic programme against antibiotic resistance.

UNKNOWN

Sponsor Role collaborator

Capio Research Foundation

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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University of Gothenburg, Dept of Infectious Diseases/Clinical Virology

Locations

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Department of Infectious Diseases, Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 21521505 (View on PubMed)

Other Identifiers

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luftvagsPCR-01

Identifier Type: -

Identifier Source: org_study_id