Oseltamivir Infant Influenza Safety Study

NCT01286142 | Completed

• 1 other identifier: NV25182
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Influenza, Human

Keywords

Prospective, Observational Safety Study

Outcome Measures

Primary Outcomes (2)

• 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.

  Study Day 7 post-baseline

• 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.

  Study Day 30 post-baseline

Secondary Outcomes (2)

• Number of subjects treated with oseltamivir

  Day 30 post baseline

• Number of subjects with drug-resistant virus

  Day 30 post-baseline

Study Arms (3)

Influenza treatment with oseltamivir

Patients 24 months of age and younger initially presenting with confirmed or presumed influenza A or B infection treated with oseltamivir.

Influenza prophylaxis with oseltamivir

Patients 24 months of age and younger prescribed oseltamivir for influenza prophylaxis

Influenza patients with no antiviral treatment

A 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.

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Charite University Berlin

Berlin, Germany

Location

Related Publications (7)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19629027 BACKGROUND

• 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.

  PMID: 16091087 BACKGROUND

• 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.

  PMID: 15933579 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Barbara Rath, MD

  Charite University Berlin, Department of Pediatrics (Div. of Pneumonology and Immunology)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Pediatric Infectious Diseases & Vaccines

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 31, 2011
• Study Start: December 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2011
• Last Updated: October 17, 2011

Record last verified: 2011-10

Locations

DE (1)