Nasal Specimen Collection Study in Patients With ILI and/or ARI in an Outpatient Setting

• Conditions: Influenza-like Illness; Influenzal Acute Respiratory Infection

• Registration Number: NCT01687816
• Lead Sponsor: Lieselot Houspie

Brief Summary

This is a prospective specimen collection study targeting patients presenting with Influenza Like Illness (ILI) and/or Acute Respiratory Infection (ARI) in an out-patient setting. A non-invasive, user friendly sampling technique, using midturbinate flocked swabs will be used. These nasal swabs will be collected in different volumes of viral transport media (0.5mL and 3.0mL), for different dilution range of the viruses present in the collected biological specimen. The collection of nasal swabs samples will support the optimization of point of care detection methods for respiratory viruses responsible for ILI and/or ARI.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Status Verified: 2012-09
• Study First Submitted: 2012-09-06
• Study First Submitted QC: 2012-09-13
• Last Update Submitted: 2012-09-13
• Study First Posted: 2012-09-19
• Last Update Posted: 2012-09-19
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Male or Female
• All Ages
• Valid Informed Consent and/or Assent, where applicable
• Onset of ILI and/or ARI within the last 3 days (≤ 72h)
• Patient presented with ILI and/or ARI

Exclusion Criteria

• Invalid Informed Consent and/or Assent
• Onset of ILI and/or ARI was > 3 days (> 72 h)
• Patient did not presented with neither ILI or ARI
• Patient received intranasal attenuated influenza virus in last 3 weeks (example FluMist®, Fluenz®)
• Patient received treatment with influenza direct antivirals in the last 7 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nasal swab collection of left and right nostril	1 day	At the moment volunteer presents him/herself to the general practioner with influenza-like-illness

Secondary Outcome Measures

Name	Time	Method
Completion of questionnaire	1 day	Competion of a short questionnaire by the GP recording the clinical symptoms of the patient with ILI

Trial Locations

Locations (1)

University of Leuven (KUL); 🇧🇪 Leuven, Belgium