Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza
A Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu®) for the Treatment of Children Less Than 24 Months of Age With Confirmed Influenza Infection (CASG 114)
4 other identifiers
interventional
87
2 countries
32
Brief Summary
The purpose of this study is to learn how to treat influenza in children less than 2 years of age. Tamiflu®, the drug being studied, is approved for treatment of children 1 year of age and older with influenza. Researchers want to learn more about the activity of Tamiflu® in the body to determine a dose of that is safe, well-tolerated, and effective in young children with influenza. Children less than 24 months of age with confirmed influenza will receive Tamiflu® 2 times a day for 5 days. Older participants will be enrolled first and younger children will be enrolled after the safety data is reviewed for older participants. Study procedures include blood samples, swabs from inside the nose, and body and nervous system evaluations. Participants may be involved in study related procedures for up to 37 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2007
Typical duration for phase_1
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2006
CompletedFirst Posted
Study publicly available on registry
October 24, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
June 20, 2011
CompletedMay 1, 2013
February 1, 2010
3.2 years
October 20, 2006
March 17, 2011
April 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oseltamivir Carboxylate AUC12 (Area Under the Curve).
The oseltamivir carboxylate AUC12 was derived from a series of five blood draws over 10 to 12 hours.
Day 3 of drug administration
Secondary Outcomes (7)
Overall Reported Adverse Events (AEs) Thought to be Associated With Study Therapy.
Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.
Number and Characteristics of Adverse Events (AEs) Described as Neurological Events.
Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.
Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade
Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days
Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort Leading to Discontinuation of Study Medication
Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 5 plus or minus 1 day
Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)
Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days
- +2 more secondary outcomes
Study Arms (1)
oseltamivir (Tamiflu®)
EXPERIMENTALInterventions
Oseltamivir is supplied as a white powder blend for constitution to a suspension. It is supplied in 100 ml amber glass bottles with 30 grams of powder for oral suspension, a plastic adapter, a plastic oral dispenser and a plastic measuring cup. Initially subjects in Cohort I received oseltamivir 30 mg orally twice daily for 5 days. The DSMB recommended on 05-Aug-2009 that weight based dosing of oseltamivir for subjects subsequently enrolled in Cohort I. Based on pharmacokinetic data available as of that date, the initial weight-based dose to be evaluated for Cohort I is 3.5 mg/kg twice a day. Cohort II and Cohort III will receive oseltamivir at 3.0 mg/kg/dose orally twice daily for 5 days. Cohorts IV and V will receive 3.0 mg/kg/dose orally twice daily for 5 days, this dose may be adjusted.
Eligibility Criteria
You may qualify if:
- Signed informed consent from parent(s) or legal guardian(s).
- Age:
- Cohort I: 12 - 23 mo. Cohort II: 9 - 11 mo. Cohort III: 6 - 8 mo. Cohort IV: 3 - 5 mo. Cohort V: 0 - 2 mo.
- Confirmed laboratory diagnosis of influenza by viral culture or rapid influenza diagnostic test within 96 hours prior to study enrollment.
- Duration of influenza symptoms less than or equal to 96 hours.
You may not qualify if:
- Concomitant vomiting illness that would preclude ability to take drug.
- Immunocompromised subject (e.g., malignancy, congenital agammaglobulinemia, HIV).
- Documented renal impairment (e.g., polycystic renal disease, nephrectomy, renal transplantation, renal agenesis, dialysis requirement, renal failure, nephrotic syndrome at any time prior to enrollment, current receipt of diuretic therapy).
- Documented hepatic impairment (e.g., congenital hepatitis, biliary atresia, cholelithiasis).
- Gastrointestinal abnormality which might hinder absorption of an oral medication.
- Current receipt of inotropic drugs (e.g., epinephrine, norepinephrine, dopamine, dobutamine).
- History of seizures.
- Documented congenital malformations of the central nervous system defined at birth (e.g., hydranencephaly, prosencephaly, spina bifida).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
University of Alabama at Birmingham
Birmingham, Alabama, 35117, United States
Arkansas Children's Hospital - Infectious Diseases
Little Rock, Arkansas, 72202-3500, United States
Miller Children's Hospital Long Beach - Bickerstaff Family Center
Long Beach, California, 90806-1701, United States
Children's Hospital of Orange County
Orange, California, 92868-3835, United States
Rady Children's Hospital San Diego
San Diego, California, 92123-4223, United States
Children's Hospital Colorado - Infectious Disease
Aurora, Colorado, 80045-7106, United States
Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease
Washington D.C., District of Columbia, 20010-2916, United States
University of Florida - Shands Children's Hospital
Gainesville, Florida, 32610-0296, United States
University of South Florida - Tampa General Hospital - Pediatrics
Tampa, Florida, 33606-3438, United States
Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, 30322-1014, United States
Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, 30322, United States
Louisiana State University Health Shreveport - Pediatrics
Shreveport, Louisiana, 71103-4228, United States
University of Mississippi - Children's Infectious Diseases
Jackson, Mississippi, 39216-4505, United States
Washington University School of Medicine in St. Louis - Center for Clinical Studies
St Louis, Missouri, 63110-1010, United States
University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases
Omaha, Nebraska, 68114-4108, United States
Cohen Children's Medical Center - Pediatric Infectious Diseases
Manhasset, New York, 11030-3816, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY Upstate Medical University Hospital - Pediatrics
Syracuse, New York, 13210-2342, United States
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, 45229-3026, United States
MetroHealth Medical Center - Pediatric Infectious Disease
Cleveland, Ohio, 44109-1998, United States
Children's Hospital of Philadelphia - The Center for Pediatric Clinical Effectiveness
Philadelphia, Pennsylvania, 19104-3309, United States
Children's Hospital of Pittsburgh of UPMC - General Academic Pediatric
Pittsburgh, Pennsylvania, 15213-3205, United States
Rhode Island Hospital - Pediatrics
Providence, Rhode Island, 02903-4923, United States
Vanderbilt University - Pediatric - Infectious Diseases
Nashville, Tennessee, 37232-0011, United States
Parkland Memorial Hospital
Dallas, Texas, 75235-7708, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9063, United States
Cook Children's Infectious Disease Services
Fort Worth, Texas, 76104-2710, United States
University of Utah - Pediatric Pharmacology Program
Salt Lake City, Utah, 84108-1457, United States
Seattle Children's Hospital - Infectious Diseases
Seattle, Washington, 98105-3901, United States
University of Alberta Hospital - Pediatrics
Edmonton, Alberta, T6G 2B7, Canada
The Hospital for Sick Children - Infectious Diseases
Toronto, Ontario, M5G 1X8, Canada
Centre Hospitalier de l'Universite Laval/ CHUQ
Québec, Quebec, G1V 4G2, Canada
Related Publications (1)
Kimberlin DW, Acosta EP, Prichard MN, Sanchez PJ, Ampofo K, Lang D, Ashouri N, Vanchiere JA, Abzug MJ, Abughali N, Caserta MT, Englund JA, Sood SK, Spigarelli MG, Bradley JS, Lew J, Michaels MG, Wan W, Cloud G, Jester P, Lakeman FD, Whitley RJ; National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. Oseltamivir pharmacokinetics, dosing, and resistance among children aged <2 years with influenza. J Infect Dis. 2013 Mar 1;207(5):709-20. doi: 10.1093/infdis/jis765. Epub 2012 Dec 10.
PMID: 23230059RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Penelope Jester
- Organization
- Collaborative Antiviral Study Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2006
First Posted
October 24, 2006
Study Start
January 1, 2007
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
May 1, 2013
Results First Posted
June 20, 2011
Record last verified: 2010-02