Influenza Clinical Trial
Official title:
Efficacy of Early Oseltamivir Phosphate Treatment at Hospital Admission to Reduce Severity of Illness Among Children Aged Less Than 10 Years Hospitalized With Influenza in El Salvador and Panama
This is a prospective, randomized, double-blind, placebo-controlled trial that will be
conducted in tertiary care pediatric hospitals in El Salvador and Panama. The primary
purpose of this study is to determine whether empiric oseltamivir phosphate treatment given
at the time of hospital admission to children less than 10 years of age hospitalized with
influenza can effectively reduce their illness severity. Additional objectives are to: 1)
evaluate the tolerability of oseltamivir phosphate treatment, 2) evaluate the effect of
oseltamivir treatment on viral clearance and development of oseltamivir-resistant influenza
virus during and after treatment in children hospitalized with influenza, 3) estimate the
direct and indirect costs of all-cause respiratory illness and influenza-associated
respiratory illness requiring hospitalization, and 4) evaluate the effect of empiric
oseltamivir treatment during the influenza season on these costs.
The primary study hypothesis is that children with laboratory-confirmed influenza receiving
empiric oseltamivir phosphate treatment initiated at the time of hospital admission will
have a shorter duration of hospitalization and a shorter time to resolution of signs of
severe respiratory illness compared to children receiving placebo. The secondary study
hypotheses are that children with laboratory-confirmed influenza receiving oseltamivir
phosphate treatment will have a reduction in the time to non-detectable influenza virus and
influenza viral RNA and children with all-cause respiratory illness receiving oseltamivir
phosphate will not be more likely to experience severe adverse events than children
receiving placebo.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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