Influenza Clinical Trial
Official title:
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)
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.
Status | Completed |
Enrollment | 87 |
Est. completion date | April 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 23 Months |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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). |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta Hospital - Pediatrics | Edmonton | Alberta |
Canada | Centre Hospitalier de l'Universite Laval/ CHUQ | Quebec | |
Canada | The Hospital for Sick Children - Infectious Diseases | Toronto | Ontario |
United States | Emory Children's Center - Pediatric Infectious Diseases | Atlanta | Georgia |
United States | Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases | Atlanta | Georgia |
United States | Children's Hospital Colorado - Infectious Disease | Aurora | Colorado |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Cincinnati Children's Hospital Medical Center - Infectious Diseases | Cincinnati | Ohio |
United States | MetroHealth Medical Center - Pediatric Infectious Disease | Cleveland | Ohio |
United States | Parkland Memorial Hospital | Dallas | Texas |
United States | The University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Cook Children's Infectious Disease Services | Fort Worth | Texas |
United States | University of Florida - Shands Children's Hospital | Gainesville | Florida |
United States | University of Mississippi - Children's Infectious Diseases | Jackson | Mississippi |
United States | Arkansas Children's Hospital - Infectious Diseases | Little Rock | Arkansas |
United States | Miller Children's Hospital Long Beach - Bickerstaff Family Center | Long Beach | California |
United States | Cohen Children's Medical Center - Pediatric Infectious Diseases | Manhasset | New York |
United States | Vanderbilt University - Pediatric - Infectious Diseases | Nashville | Tennessee |
United States | University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases | Omaha | Nebraska |
United States | Children's Hospital of Orange County | Orange | California |
United States | Children's Hospital of Philadelphia - The Center for Pediatric Clinical Effectiveness | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh of UPMC - General Academic Pediatric | Pittsburgh | Pennsylvania |
United States | Rhode Island Hospital - Pediatrics | Providence | Rhode Island |
United States | University of Rochester | Rochester | New York |
United States | Washington University School of Medicine in St. Louis - Center for Clinical Studies | Saint Louis | Missouri |
United States | University of Utah - Pediatric Pharmacology Program | Salt Lake City | Utah |
United States | Rady Children's Hospital San Diego | San Diego | California |
United States | Seattle Children's Hospital - Infectious Diseases | Seattle | Washington |
United States | Louisiana State University Health Shreveport - Pediatrics | Shreveport | Louisiana |
United States | SUNY Upstate Medical University Hospital - Pediatrics | Syracuse | New York |
United States | University of South Florida - Tampa General Hospital - Pediatrics | Tampa | Florida |
United States | Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States, Canada,
Kimberlin DW, Acosta EP, Prichard MN, Sánchez 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 I — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Overall Reported Adverse Events (AEs) Thought to be Associated With Study Therapy. | Any event considered associated with drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately. | Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days. | Yes |
Secondary | Number and Characteristics of Adverse Events (AEs) Described as Neurological Events. | Any neurological event that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately. | Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days. | Yes |
Secondary | Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade | Any event considered to be related to the study drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately. The Division of AIDS Toxicity Tables (DIAIDS) were used to grade the 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 | Yes |
Secondary | Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort Leading to Discontinuation of Study Medication | Study drug was administered for 5 days; any event that occurred prior to the last dose of study medication that was considered related to an AE and that caused the subject to stop taking study drug. | Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 5 plus or minus 1 day | Yes |
Secondary | Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC) | Serious Adverse Event (SAE) were classified by MedDRA System Organ Class (SOC). An SAE was reported if it met the following criteria and occurred after the first dose of study medication through the end of the study: death throughout study participation; life threatening; requires inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance; results in congenital anomaly or birth defect; results in a persistent or significant disability; and an event considered serious by the PI. | Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days | Yes |
Secondary | Correlation of Clearance of Viral RNA by Culture With Pharmacokinetic Parameters by Cohort | The Spearman coefficient and the p-values were computed between the clearance of Viral RNA and Oseltamivir Carboxylate Area under the curve from 0 to 12 hours (AUC0-12) | Day to negative viral load for subjects positive at baseline | No |
Secondary | Correlation of Clearance of Viral RNA by Polymerase Chain Reaction (PCR) to Pharmacokinetic Parameters by Cohort. | The Spearman coefficient and the p-values were computed between the clearance of viral RNA and oseltamivir carboxylate Area Under the Curve from 0 to 12 hours (AUC 0-12) | From date of enrollment until the date of first documented absence of viral load by culture, assessed up to 10 days after enrollment. | No |
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