Nasal Specimen Collection Study in Patients With ILI and/or ARI in an Outpatient Setting
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
Lieselot Houspie, Universitaire Ziekenhuizen Leuven
First received: September 6, 2012
Last updated: September 13, 2012
Last verified: September 2012
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.
Influenzal Acute Respiratory Infection
||Time Perspective: Prospective
||Prospective, Nasal Specimen Collection Study in Patients Presenting With Influenza Like Illness and/or Acute Respiratory Infection in an Outpatient Setting
Primary Outcome Measures:
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
Nasal swabs of left and right nostril
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
No interventions to be administered
Only a nasal swab is collected, no therapeutic interventions
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687816
|University of Leuven (KUL)
|Leuven, Belgium, 3000 |
||Marc Van Ranst, M.D., PhD
||Rega Institute, Clinical Virology, Minderbroedersstraat 10, 3000 Leuven
||Lieselot Houspie, PhD student Laboratory of Clinical Virology, Universitaire Ziekenhuizen Leuven
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 6, 2012
||September 13, 2012
||Belgium: Federal Agency for Medicinal Products and Health Products
Keywords provided by Universitaire Ziekenhuizen Leuven:
Detection of influenza
sensitivity of detection assays
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2014
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases