Panama and El Salvador Children's Oseltamivir Study
Status:
Terminated
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborators:
Hospital de Especialidades Pediátricas Omar Torrijos Herrera, Panama Hospital Del Nino, Panama Hospital Jose Domingo de Obaldia, Panama Hospital Nacional San Juan de Dios de San Miguel, El Salvador Hospital Nacional San Juan de Dios de Santa Ana, El Salvador Universidad del Valle, Guatemala