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

This study has been terminated.
(Slower than anticipated participant accrual)
Sponsor:
Collaborators:
Universidad del Valle de Guatemala, Centro de Estudios en Salud
Hospital Nacional San Juan de Dios de Santa Ana, El Salvador
Hospital Nacional San Juan de Dios de San Miguel, El Salvador
Hospital Del Nino, Panama
Hospital de Especialidades Pediátricas Omar Torrijos Herrera, Panama
Hospital Jose Domingo de Obaldia, Panama
Information provided by (Responsible Party):
Fatimah Dawood, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01690637
First received: September 17, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Influenza
Human Influenza
Drug: Oseltamivir phosphate suspension
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Length of hospitalization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected median of 7 days ] [ Designated as safety issue: No ]
    Day 1 is defined as the day of arrival at the emergency department

  • Time to resolution of increased work of breathing [ Time Frame: Participants will be followed for the duration of hospital stay, an expected median of 7 days ] [ Designated as safety issue: No ]
    Increased work of breathing is defined as presence of 1 or more of the following: supraclavicular retractions, subcostal or intercostal retractions, nasal flaring, grunting, or need for noninvasive or invasive mechanical ventilation, and resolution is defined as 12 hours or more without increased work of breathing in a child with increased work of breathing at enrollment

  • Time to resolution of hypoxia [ Time Frame: Participants will be followed for the duration of hospital stay, an expected median of 7 days ] [ Designated as safety issue: No ]
    Hypoxia is defined as O2 saturation less than 92% measured by pulse oximetry while breathing room air or need for noninvasive or invasive mechanical ventilation and resolution is defined as 12 hours or more without hypoxia in a child with hypoxia at enrollment


Secondary Outcome Measures:
  • Incidence of new onset respiratory failure 24 hours or more after first dose of study medication [ Time Frame: Participants will be followed for the duration of hospital stay, an expected median of 7 days ] [ Designated as safety issue: No ]
    Respiratory failure is defined by need for noninvasive or invasive mechanical ventilation

  • Incidence of admission to intensive care unit 24 hours or more after first dose of study medication [ Time Frame: Participants will be followed for the duration of hospital stay, an expected median of 7 days ] [ Designated as safety issue: No ]
  • Incidence of death 24 hours or more after first dose of study medication [ Time Frame: Participants will be followed up through 7 days after hospital discharge ] [ Designated as safety issue: No ]
  • Time to non-detectable influenza virus by viral culture and non-detectable influenza viral RNA by RT-PCR [ Time Frame: Participants will be followed for the duration of hospital stay (an expected median of 7 days) or up through 21 days of hospitalization, whichever is shorter ] [ Designated as safety issue: No ]
  • Proportion of children with oseltamivir resistant virus detected during or after oseltamivir phosphate treatment who had oseltamivir susceptible virus infection at enrollment [ Time Frame: Participants will be followed for the duration of hospital stay (an expected median of 7 days) or up through 21 days of hospitalization, whichever is shorter ] [ Designated as safety issue: No ]
  • Proportion of participants experiencing adverse events (including severe and non-severe) [ Time Frame: Up through 7 days after hospital discharge ] [ Designated as safety issue: Yes ]
    An adverse event is defined as any unfavorable or undesirable effect (sign, symptom, abnormality, or condition), regardless of causal relationship to study procedures or participation that occurs in participants while enrolled in this clinical trial. Any medical condition or sign/symptom that is present at the time the participant is screened is considered as baseline and not reported as an adverse event.


Enrollment: 721
Study Start Date: September 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oseltamivir phosphate suspension
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.
Drug: Oseltamivir phosphate suspension
Other Name: Tamiflu
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   up to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690637

Locations
El Salvador
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
Panama
Hospital Jose Domingo de Obaldia
David, Panama
Hospital Del Nino
Panama City, Panama
Hospital de Especialidades Pediátricas Omar Torrijos Herrera
Panama City, Panama
Sponsors and Collaborators
Universidad del Valle de Guatemala, Centro de Estudios en Salud
Hospital Nacional San Juan de Dios de Santa Ana, El Salvador
Hospital Nacional San Juan de Dios de San Miguel, El Salvador
Hospital Del Nino, Panama
Hospital de Especialidades Pediátricas Omar Torrijos Herrera, Panama
Hospital Jose Domingo de Obaldia, Panama
Investigators
Principal Investigator: Fatimah S Dawood, MD Centers for Disease Control and Prevention
Principal Investigator: Jorge Jara, MD Universidad del Valle, Guatemala
  More Information

No publications provided

Responsible Party: Fatimah Dawood, Medical Epidemiologist, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01690637     History of Changes
Other Study ID Numbers: CDC-NCIRD-6330
Study First Received: September 17, 2012
Last Updated: June 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Oseltamivir
Tamiflu

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014