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

NCT ID: NCT01687816

Last Updated: 2012-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Influenza-like Illness Influenzal Acute Respiratory Infection

Keywords

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

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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No interventions to be administered

Only a nasal swab is collected, no therapeutic interventions

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lieselot Houspie

OTHER

Sponsor Role lead

Responsible Party

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Lieselot Houspie

PhD student Laboratory of Clinical Virology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marc Van Ranst, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Rega Institute, Clinical Virology, Minderbroedersstraat 10, 3000 Leuven

Locations

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University of Leuven (KUL)

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 11576290 (View on PubMed)

Other Identifiers

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S53729

Identifier Type: -

Identifier Source: org_study_id