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Panama and El Salvador Children's Oseltamivir Study

Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza; Human Influenza

Intervention: Oseltamivir phosphate suspension (Drug); Placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Centers for Disease Control and Prevention

Official(s) and/or principal investigator(s):
Fatimah S Dawood, MD, Principal Investigator, Affiliation: Centers for Disease Control and Prevention
Jorge Jara, MD, Principal Investigator, Affiliation: Universidad del Valle, Guatemala

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Length of hospitalization

Time to resolution of increased work of breathing

Time to resolution of hypoxia

Secondary outcome:

Incidence of new onset respiratory failure 24 hours or more after first dose of study medication

Incidence of admission to intensive care unit 24 hours or more after first dose of study medication

Incidence of death 24 hours or more after first dose of study medication

Time to non-detectable influenza virus by viral culture and non-detectable influenza viral RNA by RT-PCR

Proportion of children with oseltamivir resistant virus detected during or after oseltamivir phosphate treatment who had oseltamivir susceptible virus infection at enrollment

Proportion of participants experiencing adverse events (including severe and non-severe)

Eligibility

Minimum age: N/A. Maximum age: 9 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age <10 years

- Accompanied by a parent or guardian who has the capacity to grant and sign the

written informed consent and who has consented to enrollment

- Has respiratory illness as defined by modified IMCI criteria for pneumonia:

- Cough or sore throat AND Fast breathing, defined as respiratory rate 60 breaths per

minutes or greater for children 0 to <2 months, OR respiratory rate 50 breaths per minute or greater for children 2 to <12 months, OR respiratory rate 40 breaths per minute or greater for children 12 to <60 months, OR respiratory rate 30 breaths per minute or greater for children 5-9 years

- Planned for hospital admission

Exclusion Criteria:

- Symptom onset 7 days or more at the time of study screening where day 1 is the day of

symptom onset

- Concomitant severe vomiting illness prior to enrollment that would preclude ability

to take medication orally defined as more than 3 vomiting episodes in the preceding 24 hours

- Prematurity (birth at less than 37 weeks gestation) for children aged less than 3

months

- Birth weight less than 2500 grams for children aged less than 3 months

- Chronic supplemental oxygen requirement at home

- Known history of renal dysfunction

- History of gastrointestinal resection resulting in gastrointestinal abnormality that

might hinder absorption of oral medication (such as short-gut syndrome)

- History of previous serious adverse reaction to oseltamivir phosphate

- Receipt of oseltamivir phosphate during the 5 days prior to presentation at the

admitting hospital

- Previous enrollment in this study during a hospitalization that ended less than 14

days prior to the current admission

Locations and Contacts

Hospital Nacional San Juan de Dios de San Miguel, San Miguel, El Salvador

Hospital Nacional San Juan de Dios de Santa Ana, Santa Ana, El Salvador

Hospital Jose Domingo de Obaldia, David, Panama

Hospital de Especialidades Pediátricas Omar Torrijos Herrera, Panama City, Panama

Hospital Del Nino, Panama City, Panama

Additional Information

Starting date: September 2012
Last updated: June 30, 2014

Page last updated: August 23, 2015

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