Panama and El Salvador Children's Oseltamivir Study (PECOS)

Centers for Disease Control and Prevention (CDC)

Status and phase: Terminated; Phase 4

Conditions: Human Influenza; Influenza

Treatments: Drug: Oseltamivir phosphate suspension; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01690637

CDC-NCIRD-6330

Details and patient eligibility

About

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.

Enrollment: 721 patients

Sex: All

Ages: Under 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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721 participants in 2 patient groups, including a placebo group

Oseltamivir phosphate suspension

Active Comparator group

Description:

Participants assigned to the oseltamivir phosphate treatment arm will receive the appropriate weight-based dose of oseltamivir phosphate every 12 hours for 10 doses. For children 0-11 months of age, oseltamivir phosphate will be dosed as 3mg/kg/dose every 12 hours. For children 12 months and older, oseltamivir phosphate will be dosed as follows: 30 mg every 12 hours for children up to 15kg, 45mg every 12 hours for children greater than 15kg up to 23 kg, 60mg every 12 hours for children greater than 23 up to 40kg, and 75mg every 12 hours for children greater than 40kg.

Treatment:

Drug: Oseltamivir phosphate suspension

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo