InfluenzaPhase 4PECOSNCT01690637
Panama and El Salvador Children's Oseltamivir Study
A Phase 4 study testing Oseltamivir phosphate suspension in people with Influenza and Human Influenza, run by Centers for Disease Control and Prevention at 5 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages Up to 9 years
- Conditions the study is for
- Influenza, Human Influenza
- What is being tested?
- Oseltamivir phosphate suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 721 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2012to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Panama3 sites
Hospital Jose Domingo de Obaldia
David
Hospital de Especialidades Pediátricas Omar Torrijos Herrera
Panama City
Hospital Del Nino
Panama City
El Salvador2 sites
Hospital Nacional San Juan de Dios de San Miguel
San Miguel
Hospital Nacional San Juan de Dios de Santa Ana
Santa Ana
About this study
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
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.
- Conditions
- Influenza, Human Influenza
- Being tested
- Oseltamivir phosphate suspension, Placebo
- Keywords
- Oseltamivir, Tamiflu
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oseltamivir phosphate suspensionDrug
Also called Tamiflu
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir phosphate suspension | Active comparator | 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. Receives: Drug: Oseltamivir phosphate suspension |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospitalization
Day 1 is defined as the day of arrival at the emergency department
Measured: Participants will be followed for the duration of hospital stay, an expected median of 7 days
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
Measured: Participants will be followed for the duration of hospital stay, an expected median of 7 days
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
Measured: Participants will be followed for the duration of hospital stay, an expected median of 7 days
Secondary outcomes (6)
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
Measured: Participants will be followed for the duration of hospital stay, an expected median of 7 days
Incidence of admission to intensive care unit 24 hours or more after first dose of study medication
Measured: Participants will be followed for the duration of hospital stay, an expected median of 7 days
Incidence of death 24 hours or more after first dose of study medication
Measured: Participants will be followed up through 7 days after hospital discharge
Time to non-detectable influenza virus by viral culture and non-detectable influenza viral RNA by RT-PCR
Measured: 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
Proportion of children with oseltamivir resistant virus detected during or after oseltamivir phosphate treatment who had oseltamivir susceptible virus infection at enrollment
Measured: 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
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.
Measured: Up through 7 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Slower than anticipated participant accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- 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
- Responsible party
- Principal investigator, Fatimah Dawood, Centers for Disease Control and Prevention
- Investigators
- Fatimah S Dawood, MD, Principal investigator, Centers for Disease Control and PreventionJorge Jara, MD, Principal investigator, Universidad del Valle, Guatemala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690637
- Sponsor's protocol ID
- CDC-NCIRD-6330
- Acronym
- PECOS
- Status last verified
- Jun 2014
- First submitted
- 17 Sep 2012
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31153920
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01690637
- Acronym / sponsor ID
- PECOS / CDC-NCIRD-6330
- Conditions
- Influenza, Human Influenza
- Keywords
- Oseltamivir, Tamiflu
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slower than anticipated participant accrual
- Enrolment
- 721 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- 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
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir phosphate suspension | Active comparator | Drug: Oseltamivir phosphate suspensionParticipants 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. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- Up to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oseltamivir phosphate suspensionAlso: Tamiflu | Drug | Oseltamivir phosphate suspension |
| Placebo | Drug | Placebo |
Primary outcome
Length of hospitalization
Time frame: Participants will be followed for the duration of hospital stay, an expected median of 7 days
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
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
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
6 secondary outcomes
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
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
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
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
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
Proportion of participants experiencing adverse events (including severe and non-severe)
Time frame: Up through 7 days after hospital discharge
Results and safety
The study was stopped early (reason given: Slower than anticipated participant accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Derived from this study: PubMed 31153920Jara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatimah S Dawood, MD principal investigator
Centers for Disease Control and Prevention
Jorge Jara, MD principal investigator
Universidad del Valle, Guatemala
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oseltamivir phosphate suspension in people with Influenza and Human Influenza, run by Centers for Disease Control and Prevention at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Panama, El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slower than anticipated participant accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospitalization (time frame: Participants will be followed for the duration of hospital stay, an expected median of 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.