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

September 13, 2012 updated by: Lieselot Houspie

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University of Leuven (KUL)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No interventions to be administered
Only a nasal swab is collected, no therapeutic interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal swab collection of left and right nostril
Time Frame: 1 day
At the moment volunteer presents him/herself to the general practioner with influenza-like-illness
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of questionnaire
Time Frame: 1 day
Competion of a short questionnaire by the GP recording the clinical symptoms of the patient with ILI
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lieselot Houspie

Investigators

  • Principal Investigator: Marc Van Ranst, M.D., PhD, Rega Institute, Clinical Virology, Minderbroedersstraat 10, 3000 Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

September 6, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 13, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S53729

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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