Oseltamivir Infant Influenza Safety Study

Influenza, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286142
• Other study ID #: NV25182
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: October 13, 2011
• Start date: December 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: September 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza, Human

Locations

Country	Name	City	State
Germany	Charite University Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

References & 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.

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. — View Citation

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.

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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.	Day 30 post baseline	Yes
Secondary	Number of subjects with drug-resistant virus	Data on oseltamivir resistance are collected (as reported only)	Day 30 post-baseline	No