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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01133782
Acronym
luftvagsPCR
Enrollment
406
Registered
2010-05-31
Start date
2006-10-31
Completion date
2009-04-30
Last updated
2010-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Tract Infection

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.

Interventions

PROCEDUREAccess to diagnostic test

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

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Strama - the Swedish strategic programme against antibiotic resistance.
CollaboratorUNKNOWN
Capio Research Foundation
CollaboratorOTHER
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Antibiotic treatment prescriped at initial visitWithin 2 days of initial visitAntibiotic prescriptions are measured as an outcome of the diagnostic procedure tested.

Secondary

MeasureTime frameDescription
Antibiotic treatment prescribed or reported at follow-up visit10+/-2 daysAntibiotic prescriptions at follow visit are measured as an outcome of the diagnostic procedure tested.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026