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

NCT01687816 | Unknown DMC

• 1 other identifier: S53729
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza-like Illness; Influenzal Acute Respiratory Infection

Keywords

Influenza-Like-Illness; nasal swabs; Detection of influenza; sensitivity of detection assays

Outcome Measures

Primary Outcomes (1)

• Nasal swab collection of left and right nostril

  At the moment volunteer presents him/herself to the general practioner with influenza-like-illness

  1 day

Secondary Outcomes (1)

• Completion of questionnaire

  1 day

Study Arms (1)

No interventions to be administered

Only a nasal swab is collected, no therapeutic interventions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with ILI will present with a sudden onset of symptoms and at least one of the following four symptoms: fever or feverishness, malaise, headache, myalgia and at least one of the following three respiratory symptoms: cough, sore throat, shortness of breath. Patients with ARI will present with a sudden onset of symptoms and at least one of the following four respiratory symptoms: cough, sore throat, shortness of breath, coryza and the GP's judgment that the illness is due to an infection.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lieselot Houspie: lead

Study Sites (1)

University of Leuven (KUL)

Leuven, 3000, Belgium

Location

Related Publications (1)

• Potter CW. A history of influenza. J Appl Microbiol. 2001 Oct;91(4):572-9. doi: 10.1046/j.1365-2672.2001.01492.x. No abstract available.

  PMID: 11576290 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swabs of left and right nostril

Study Officials

• Marc Van Ranst, M.D., PhD

  Rega Institute, Clinical Virology, Minderbroedersstraat 10, 3000 Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student Laboratory of Clinical Virology

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 19, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 19, 2012

Record last verified: 2012-09

Locations

BE (1)