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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lieselot Houspie, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01687816
First received: September 6, 2012
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Influenza-like Illness
Influenzal Acute Respiratory Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective, Nasal Specimen Collection Study in Patients Presenting With Influenza Like Illness and/or Acute Respiratory Infection in an Outpatient Setting

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Nasal swab collection of left and right nostril [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    At the moment volunteer presents him/herself to the general practioner with influenza-like-illness


Secondary Outcome Measures:
  • Completion of questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Competion of a short questionnaire by the GP recording the clinical symptoms of the patient with ILI


Biospecimen Retention:   Samples With DNA

Nasal swabs of left and right nostril


Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
No interventions to be administered
Only a nasal swab is collected, no therapeutic interventions

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687816

Locations
Belgium
University of Leuven (KUL)
Leuven, Belgium, 3000
Sponsors and Collaborators
Lieselot Houspie
Investigators
Principal Investigator: Marc Van Ranst, M.D., PhD Rega Institute, Clinical Virology, Minderbroedersstraat 10, 3000 Leuven
  More Information

Publications:

Responsible Party: Lieselot Houspie, PhD student Laboratory of Clinical Virology, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01687816     History of Changes
Other Study ID Numbers: S53729
Study First Received: September 6, 2012
Last Updated: September 13, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
Influenza-Like-Illness
nasal swabs
Detection of influenza
sensitivity of detection assays

Additional relevant MeSH terms:
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Infection

ClinicalTrials.gov processed this record on May 23, 2013