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

Influenza-like Illness Clinical Trial

Official title:

Prospective, Nasal Specimen Collection Study in Patients Presenting With Influenza Like Illness and/or Acute Respiratory Infection in an Outpatient Setting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01687816
• Other study ID #: S53729
• Status: Active, not recruiting
• Phase: N/A
• First received: September 6, 2012
• Last updated: September 13, 2012
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2012
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza, Human
• Influenza-like Illness
• Influenzal Acute Respiratory Infection
• Respiratory Tract Infections

Locations

Country	Name	City	State
Belgium	University of Leuven (KUL)	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Lieselot Houspie

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Potter CW. A history of influenza. J Appl Microbiol. 2001 Oct;91(4):572-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Completion of questionnaire	Competion of a short questionnaire by the GP recording the clinical symptoms of the patient with ILI	1 day	No