Influenza-like IllnessNCT01687816
Nasal Specimen Collection Study in Patients With ILI and/or ARI in an Outpatient Setting
An observational study of Influenza-like Illness and Influenzal Acute Respiratory Infection, run by Lieselot Houspie at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza-like Illness, Influenzal Acute Respiratory Infection
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Influenza-Like-Illness, nasal swabs, Detection of influenza, sensitivity of detection assays
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No interventions to be administered | Only a nasal swab is collected, no therapeutic interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal swab collection of left and right nostril
At the moment volunteer presents him/herself to the general practioner with influenza-like-illness
Measured: 1 day
Secondary outcomes (1)
Completion of questionnaire
Competion of a short questionnaire by the GP recording the clinical symptoms of the patient with ILI
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza-like IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lieselot Houspie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lieselot Houspie, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Marc Van Ranst, M.D., PhD, Principal investigator, Rega Institute, Clinical Virology, Minderbroedersstraat 10, 3000 Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687816
- Sponsor's protocol ID
- S53729
- Status last verified
- Sep 2012
- First submitted
- 6 Sep 2012
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11576290
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Nasal Specimen Collection Study in Patients Presenting With Influenza Like Illness and/or Acute Respiratory Infection in an Outpatient Setting
- ClinicalTrials.gov ID
- NCT01687816
- Acronym / sponsor ID
- S53729
- Keywords
- Influenza-Like-Illness, nasal swabs, Detection of influenza, sensitivity of detection assays
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Lieselot HouspieUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No interventions to be administered | – | –Only a nasal swab is collected, no therapeutic interventions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Completion of questionnaire
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
- Background: PubMed 11576290Potter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Van Ranst, M.D., PhD principal investigator
Rega Institute, Clinical Virology, Minderbroedersstraat 10, 3000 Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza-like Illness and Influenzal Acute Respiratory Infection, run by Lieselot Houspie at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal swab collection of left and right nostril (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01687816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.