Panama and El Salvador Children's Oseltamivir Study

Influenza Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01690637
• Other study ID #: CDC-NCIRD-6330
• Status: Terminated
• Phase: Phase 4
• First received: September 17, 2012
• Last updated: June 30, 2014
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: June 2014
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 721
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 9 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Human Influenza
• Influenza
• Influenza, Human

Intervention

Drug:
• Oseltamivir phosphate suspension

• Placebo

Locations

Country	Name	City	State
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
Panama	Hospital Jose Domingo de Obaldia	David
Panama	Hospital de Especialidades Pediátricas Omar Torrijos Herrera	Panama City
Panama	Hospital Del Nino	Panama City

Sponsors (7)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	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

Countries where clinical trial is conducted

El Salvador,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospitalization	Day 1 is defined as the day of arrival at the emergency department	Participants will be followed for the duration of hospital stay, an expected median of 7 days	No
Primary	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	Participants will be followed for the duration of hospital stay, an expected median of 7 days	No
Primary	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	Participants will be followed for the duration of hospital stay, an expected median of 7 days	No
Secondary	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	Participants will be followed for the duration of hospital stay, an expected median of 7 days	No
Secondary	Incidence of admission to intensive care unit 24 hours or more after first dose of study medication		Participants will be followed for the duration of hospital stay, an expected median of 7 days	No
Secondary	Incidence of death 24 hours or more after first dose of study medication		Participants will be followed up through 7 days after hospital discharge	No
Secondary	Time to non-detectable influenza virus by viral culture and non-detectable influenza viral RNA by RT-PCR		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	No
Secondary	Proportion of children with oseltamivir resistant virus detected during or after oseltamivir phosphate treatment who had oseltamivir susceptible virus infection at enrollment		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	No
Secondary	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.	Up through 7 days after hospital discharge	Yes