CClinicalTrials.gg
CompletedNCT01133782luftvagsPCRUpdated May 31, 2010

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

An interventional study of Access to diagnostic test in Acute Respiratory Tract Infection, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-05-31.

Sponsored by Göteborg University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
406
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Acute Respiratory Tract Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 406 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • >14 days of symptoms
  • confirmed bacterial infection
  • Hospital acquired infection (>3days in hospital)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
406 participants (actual)

Study arms

  • Experimental
    Rapid result

    Result of diagnostic PCR panel provided the following day

    Procedure: Access to diagnostic test

  • No intervention
    Delayed result

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

Interventions

  • ProcedureAccess to diagnostic test

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

06

What researchers measure

Primary outcomes

  1. Antibiotic treatment prescriped at initial visit

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

    Time frame: Within 2 days of initial visit

Secondary outcomes

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

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

    Time frame: 10+/-2 days

07

Study locations

1 site
  • Department of Infectious Diseases, Sahlgrenska University Hospital
    Gothenburg, se-41685, Sweden
08

References and documents

Publications

  • 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. PubMed 21521505 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01133782
Lead sponsor
Göteborg University
Collaborators
Vastra Gotaland Region, Strama - the Swedish strategic programme against antibiotic resistance., Capio Research Foundation
First posted
May 31, 2010
Start date
Oct 2006
Primary completion
Apr 2009
Completion
Apr 2009
Last update
May 31, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion