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Influenza, HumanNCT01286142

Oseltamivir Infant Influenza Safety Study

An observational study of Influenza, Human, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In June 2009, the World Health Organization (WHO) declared a global pandemic of influenza A (H1N1). Although little is known about the pandemic influenza strain in children, during previous pandemics and influenza seasons children less than one year of age were shown to be at higher risk of influenza complications… Read more about this study

Who is it for?
Ages 1 day to 24 months
Conditions the study is for
Influenza, Human
How many people
900 participants
Where
1 siteGermany
Study dates
Dec 2009to Sep 2011
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 1 day to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: The study will be conducted in multiple sites in multiple countries within the European Union. Initially, five countries (United Kingdom, Austria, Finland, Poland, Germany) are selected for inclusion, but additional countries in Europe, are likely to be added. It is estimated that 3-12 sites per country will be enrolled, with a target of at least 900 patients. If additional countries are added, the number of sites/patients recruited per country will be adjusted accordingly.

Who may be able to join

  • 24 months of age or younger at time of enrollment
  • Diagnosis of influenza A or B (suspected* or confirmed by viral testing) either treated with oseltamivir or with no antivirals OR prescribed oseltamivir for post-exposure influenza prophylaxis
  • Parent/legal guardian willing to provide informed consent and be contacted by telephone as part of follow-up

Who cannot join

  • Patients will be excluded if treated with an influenza antiviral other than oseltamivir, including amantadine, rimantadine, or zanamivir.
  • Suspected influenza is defined as an acute febrile illness characterized by the presence of fever and 1 or more of the following symptoms: cough, coryza/nasal congestion or sore throat.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charite University Berlin

    Berlin

Other trials in Germany

About this study

Official title: A Prospective, Observational Safety Study in Children <= 24 Months of Age Receiving Oseltamivir for the Treatment or Prophylaxis of Influenza Infection

In June 2009, the World Health Organization (WHO) declared a global pandemic of influenza A (H1N1). Although little is known about the pandemic influenza strain in children, during previous pandemics and influenza seasons children less than one year of age were shown to be at higher risk of influenza complications than older children. In light of the 2009 H1N1 pandemic situation, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada issued emergency authorizations for oseltamivir to be used to treat and prevent influenza in infants under 1 year of age. It is anticipated that oseltamivir use in infants will dramatically increase due to the new authorizations for use in this population and high prevalence of H1N1 influenza circulating in the population. Ongoing safety surveillance is critical and this study will provide further data for evaluating the risk/benefit ratio of prescribing oseltamivir to this population in the current milieu of both seasonal and pandemic influenza viruses circulating in the population. The study will also provide useful information on the dose and duration of treatment used in clinical practice and their relationship to adverse events.

Read the detailed description

This study is a prospective, observational, multicenter short-term safety study of the use of oseltamivir (prophylaxis or treatment) in children 24 months of age or younger. An internal comparator group of children diagnosed with influenza and not treated with antiviral medications will be enrolled. The study includes a 30-day follow-up period and will be conducted in multiple sites in multiple countries within the European Union. The study will cover two consecutive influenza seasons: 01 October 2009 - 31 May 2010 and 01 October 2010 - 31 May 2011. Data collection may be interrupted in the interim period between influenza seasons (June 1, 2010 - September 30, 2010), depending on whether the influenza season follows the expected cycle.

Keywords
Prospective, Observational Safety Study
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01286142
Study groupRoleWhat they receive
Influenza treatment with oseltamivirPatients 24 months of age and younger initially presenting with confirmed or presumed influenza A or B infection treated with oseltamivir.
Influenza prophylaxis with oseltamivirPatients 24 months of age and younger prescribed oseltamivir for influenza prophylaxis
Influenza patients with no antiviral treatmentA comparator group of patients 24 months of age and younger presenting with confirmed or presumed influenza A or B and not treated with any influenza antiviral.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with Adverse Events

    Information on the number of subjects with AEs will be collected at 7 days post-baseline. AEs include influenza symptoms and associated complications solicited from parent/legal guardian; secondary complications of influenza reported by physician, including otitis media and bacterial infections; and any other non-serious and serious AEs.

    Measured: Study Day 7 post-baseline

  2. Number of subjects with Adverse Events

    Information on the number of subjects with AEs will be collected at 30 days post-baseline. AEs include influenza symptoms and associated complications solicited from parent/legal guardian; secondary complications of influenza reported by physician, including otitis media and bacterial infections; and any other non-serious and serious AEs.

    Measured: Study Day 30 post-baseline

Secondary outcomes (2)

  1. Number of subjects treated with oseltamivir

    Data on dosage and duration of treatment with oseltamivir in real-world practice are collected. The aim is to examine the relationship of adverse events to the regimen of oseltamivir.

    Measured: Day 30 post baseline

  2. Number of subjects with drug-resistant virus

    Data on oseltamivir resistance are collected (as reported only)

    Measured: Day 30 post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2011 (estimated)
  2. Study startDec 2009
  3. Primary completionJul 2010
  4. Study completionSep 2011

Resources

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
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01286142
Sponsor's protocol ID
NV25182
Status last verified
Oct 2011
First submitted
24 Jan 2011
Last updated
17 Oct 2011
Results posted
No
Data monitoring committee
No

Publications

  • Centers for Disease Control and Prevention (CDC). Interim Guidance for Clinicians on the Prevention and Treatment of Novel Influenza A (H1N1) Influenza Virus Infection in Infants and Children. 13 May 2009. Available at http://cdc.gov/h1n1flu/childrentreatment.htm. Accessed 03 Aug 2009.

  • European Medicines Agency (EMA), Committee for Medicinal Products for Human Use. CHMP ASSESSMENT REPORT on Novel Influenza (H1N1) outbreak Tamiflu (oseltamivir) Relenza (zanamivir) [EMEA/CHMP/287662/2009]. 07 May 2009. Available at http://www.emea.europa.eu/humandocs/PDFs/EPAR/tamiflu/28766209en.pdf. Accessed 28 July 2009.

  • Food and Drug Administration (FDA). Emergency Use Authorization Letter - Tamiflu. 14 July 2009. Available at http://www.cdc.gov/h1n1flu/eua/pdf/fda_letter_tamiflu.pdf. Accessed 03 Aug 2009.

  • World Health Organization. 11 Jun 2009. Available at: http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html. Accessed 03 Aug 2009.

  • Centers for Disease Control and Prevention (CDC). Neurologic complications associated with novel influenza A (H1N1) virus infection in children - Dallas, Texas, May 2009. MMWR Morb Mortal Wkly Rep. 2009 Jul 24;58(28):773-8.

    PubMed 19629027

  • Tamura D, Miura T, Kikuchi Y. Oseltamivir phosphate in infants under 1 year of age with influenza infection. Pediatr Int. 2005 Aug;47(4):484. doi: 10.1111/j.1442-200x.2005.02088.x. No abstract available.

    PubMed 16091087

  • Okamoto S, Kamiya I, Kishida K, Shimakawa T, Fukui T, Morimoto T. Experience with oseltamivir for infants younger than 1 year old in Japan. Pediatr Infect Dis J. 2005 Jun;24(6):575-6. doi: 10.1097/01.inf.0000164799.33635.fe. No abstract available.

    PubMed 15933579

Questions about this trial

What is this clinical trial studying?

An observational study of Influenza, Human, run by Charite University, Berlin, Germany at 1 site in Germany.

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 3 inclusion and 2 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 17 Oct 2011. 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 Germany. 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?

Number of subjects with Adverse Events (time frame: Study Day 7 post-baseline). The study lists 2 primary outcomes in all. 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 NCT01286142, which also lists 7 linked publications.

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 17 Oct 2011.

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