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

NCT01133782 | Completed

• 1 other identifier: luftvagsPCR-01
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• Antibiotic treatment prescriped at initial visit

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

  Within 2 days of initial visit

Secondary Outcomes (1)

• Antibiotic treatment prescribed or reported at follow-up visit

  10+/-2 days

Study Arms (2)

Rapid result

EXPERIMENTAL

Result of diagnostic PCR panel provided the following day

Procedure: Access to diagnostic test

Delayed result

NO INTERVENTION

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

Interventions

Access to diagnostic test PROCEDURE

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

Rapid result

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator
• Strama - the Swedish strategic programme against antibiotic resistance.: collaborator
• Capio Research Foundation: collaborator

Study Sites (1)

Department of Infectious Diseases, Sahlgrenska University Hospital

Gothenburg, se-41685, Sweden

Location

Related Publications (1)

• 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.

  PMID: 21521505 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: May 31, 2010
• Study Start: October 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 31, 2010

Record last verified: 2006-10

Locations

SE (1)