Safety and Efficacy of Oseltamivir in Children Younger Than One Year of Age

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Currently, there is no standard treatment for influenza with related lower respiratory tract infection (LRTI) in children younger than one year of age, even though influenza related LRTI is a potentially fatal illness in these children. This study will test a medicine for influenza in children younger than one year of age to see if it is safe and effective.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• Informed consent signed by a parent or legal guardian

• Younger than 12 months of age when first seen with a lower respiratory tract infection (LRTI)

• LRTI must be moderate or severe and influenza must be virologically proven by a respiratory specimen

• History of fever within 14 days prior to presentation (although fever at presentation is not required) plus any two of the following: cough, difficulty breathing or shortness of breath, increased respiratory rate for current age, intercostal recession, use of accessory muscles, nasal flare or grunting, crepitations with or without wheezing, a consistent abnormal chest x-ray (e.g., new infiltrate, hyperinflation)

• Virological evidence of influenza on any one of the tests specified in the protocol

Exclusion Criteria for Children with Non-Avian Influenza:

• Known allergy to oseltamivir

Additional Exclusion Criteria for Children with Non-Avian Influenza:

• Illness duration greater than 14 days on the day of hospital admission

• Creatinine clearance less than 10 mL/min/1.73m2, including a requirement for dialysis or hemofiltration