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

Primary Purpose

Influenza, Human Influenza

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Oseltamivir phosphate suspension
Placebo
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza focused on measuring Oseltamivir, Tamiflu

Eligibility Criteria

undefined - 9 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Hospital Nacional San Juan de Dios de San Miguel
  • Hospital Nacional San Juan de Dios de Santa Ana
  • Hospital Jose Domingo de Obaldia
  • Hospital de Especialidades Pediátricas Omar Torrijos Herrera
  • Hospital Del Nino

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oseltamivir phosphate suspension

Placebo

Arm 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.

Outcomes

Primary Outcome Measures

Length of hospitalization
Day 1 is defined as the day of arrival at the emergency department
Time to resolution of increased work of breathing
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
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
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
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)
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.

Full Information

First Posted
September 17, 2012
Last Updated
June 30, 2014
Sponsor
Centers for Disease Control and Prevention
Collaborators
Universidad del Valle, Guatemala, 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
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1. Study Identification

Unique Protocol Identification Number
NCT01690637
Brief Title
Panama and El Salvador Children's Oseltamivir Study
Acronym
PECOS
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 Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
Slower than anticipated participant accrual
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Universidad del Valle, Guatemala, 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human Influenza
Keywords
Oseltamivir, Tamiflu

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
721 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oseltamivir phosphate suspension
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oseltamivir phosphate suspension
Other Intervention Name(s)
Tamiflu
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Length of hospitalization
Description
Day 1 is defined as the day of arrival at the emergency department
Time Frame
Participants will be followed for the duration of hospital stay, an expected median of 7 days
Title
Time to resolution of increased work of breathing
Description
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 Frame
Participants will be followed for the duration of hospital stay, an expected median of 7 days
Title
Time to resolution of hypoxia
Description
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
Time Frame
Participants will be followed for the duration of hospital stay, an expected median of 7 days
Secondary Outcome Measure Information:
Title
Incidence of new onset respiratory failure 24 hours or more after first dose of study medication
Description
Respiratory failure is defined by need for noninvasive or invasive mechanical ventilation
Time Frame
Participants will be followed for the duration of hospital stay, an expected median of 7 days
Title
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
Title
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
Title
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
Title
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
Title
Proportion of participants experiencing adverse events (including severe and non-severe)
Description
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.
Time Frame
Up through 7 days after hospital discharge

10. Eligibility

Sex
All
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatimah S Dawood, MD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorge Jara, MD
Organizational Affiliation
Universidad del Valle, Guatemala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nacional San Juan de Dios de San Miguel
City
San Miguel
Country
El Salvador
Facility Name
Hospital Nacional San Juan de Dios de Santa Ana
City
Santa Ana
Country
El Salvador
Facility Name
Hospital Jose Domingo de Obaldia
City
David
Country
Panama
Facility Name
Hospital de Especialidades Pediátricas Omar Torrijos Herrera
City
Panama City
Country
Panama
Facility Name
Hospital Del Nino
City
Panama City
Country
Panama

12. IPD Sharing Statement

Citations:
PubMed Identifier
31153920
Citation
Jara JH, Azziz-Baumgartner E, De Leon T, Luciani K, Brizuela YS, Estripeaut D, Castillo JM, Barahona A, Corro M, Cazares R, Vergara O, Rauda R, Gonzalez R, Franco D, Widdowson MA, Clara W, Alvis-Estrada JP, Murray CT, Ortega-Sanchez IR, Dawood FS. Costs associated with acute respiratory illness and select virus infections in hospitalized children, El Salvador and Panama, 2012-2013. J Infect. 2019 Aug;79(2):108-114. doi: 10.1016/j.jinf.2019.05.021. Epub 2019 May 31.
Results Reference
derived

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Panama and El Salvador Children's Oseltamivir Study

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