HealthyNCT01022931
Epidemiology and Clinical Presentation of H1N1 Infection in Children in Geneva
An observational study of Healthy and Immunosuppressed, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
This study aims to identify clinical symptoms and outcomes, as well as response to anti-viral treatment in children living in Geneva, with influenza A/ H1N1 infection during the current pandemic. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Healthy, Immunosuppressed, Asthmatic
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2009to Jul 2012
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children seen at the emergency ward
Who may be able to join
- suspicion of H1N1 infection
Who cannot join
- Not available for a 30 days follow-up
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Children's Hospital of Geneva, HUG
Geneva, Canton of Geneva, 1211
About this study
Official title: Evaluation of a New Virus(Influenza A H1N1/09) in Children: Epidemiology, Clinical Presentation and Outcome, and Response to Treatment
This study aims to identify clinical symptoms and outcomes, as well as response to anti-viral treatment in children living in Geneva, with influenza A/ H1N1 infection during the current pandemic.
- Conditions
- Healthy, Immunosuppressed, Asthmatic, Neuromuscular Diseases
- Keywords
- Influenza A H1N1, Children, Epidemiology, Treatment, Oseltamivir, Genetics
- Medical subject headings
- Asthma, Neuromuscular Diseases, Orthomyxoviridae Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
ABCB1 polymorphisms
ABCB1 gene polymorphisms and neuropsychiatric adverse events in oseltamivir-treated children during influenza H1N1/09 pandemia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klara M. Pósfay Barbe, University Hospital, Geneva
- Investigators
- Klara M Posfay-Barbe, MD, MS, Principal investigator, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022931
- Sponsor's protocol ID
- H1N1epidemiology
- Status last verified
- Dec 2012
- First submitted
- 30 Nov 2009
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Virus(Influenza A H1N1/09) in Children: Epidemiology, Clinical Presentation and Outcome, and Response to Treatment
- ClinicalTrials.gov ID
- NCT01022931
- Acronym / sponsor ID
- H1N1epidemiology
- Conditions
- Healthy, Immunosuppressed, Asthmatic, Neuromuscular Diseases
- Keywords
- Influenza A H1N1, Children, Epidemiology, Treatment, Oseltamivir, Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Dec 2009 (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 study aims to identify clinical symptoms and outcomes, as well as response to anti-viral treatment in children living in Geneva, with influenza A/ H1N1 infection during the current pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children seen at the emergency ward
Key inclusion criteria (1 listed)
- suspicion of H1N1 infection
Key exclusion criteria (1 listed)
- Not available for a 30 days follow-up
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
ABCB1 polymorphisms
Time frame: 6 months
ABCB1 gene polymorphisms and neuropsychiatric adverse events in oseltamivir-treated children during influenza H1N1/09 pandemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
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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.
Klara M Posfay-Barbe, MD, MS principal investigator
University Hospitals of Geneva
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 Healthy and Immunosuppressed, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Dec 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ABCB1 polymorphisms (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2012.