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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01687816

Enrollment

300

Registered

2012-09-19

Start date

2012-02-29

Completion date

2013-12-31

Last updated

2012-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenzal Acute Respiratory Infection, Influenza-like Illness

Keywords

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

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Outcome results