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OpenTrials
Completed

NCT Number: NCT01133782

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Infectious Diseases, Sahlgrenska University Hospital

Gothenburg, se-41685, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Access to diagnostic test

Procedure

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

Primary outcomes

  1. Antibiotic treatment prescriped at initial visit

    Time frame: Within 2 days of initial visit

    Antibiotic prescriptions are measured as an outcome of the diagnostic procedure tested.

Secondary outcomes

  1. Antibiotic treatment prescribed or reported at follow-up visit

    Time frame: 10+/-2 days

    Antibiotic prescriptions at follow visit are measured as an outcome of the diagnostic procedure tested.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Capio Research Foundation
  • Strama - the Swedish strategic programme against antibiotic resistance.
  • Vastra Gotaland Region

Registry information

Acronym: luftvagsPCR

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 31, 2010
Registry last updated
May 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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