A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza
NCT ID: NCT01053663
Last Updated: 2016-07-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2011-01-31
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza
NCT01033734
A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection
NCT00988325
Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza
NCT00391768
Safety and Efficacy of Oseltamivir in Children Younger Than One Year of Age
NCT01037634
A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.
NCT00412555
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Tamiflu
10 doses over 5 or 6 days of which the first 5 or 6 doses must be intravenous, up to 5 days (10 doses) of additional intravenously or oral treatment if virus shedding continues at day 6
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tamiflu
10 doses over 5 or 6 days of which the first 5 or 6 doses must be intravenous, up to 5 days (10 doses) of additional intravenously or oral treatment if virus shedding continues at day 6
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Date of birth to date of enrollment is \<1 year
* Diagnosis of influenza
* Duration of influenza symptoms \</=96 hours prior to first dose
* \- Parent/guardian willing to have patient receive intravenous therapy for 3 or 4 days (5 or 6 doses of study drug)
Exclusion Criteria
* Creatinine clearance \<30 mL/min/1.73m2
* Patients receiving any form of renal replacement therapy at baseline
* Clinical evidence of severe hepatic decompensation at the time of enrollment
* Patients taking probenecid medication within 1 week prior to study day 1 or during the study
365 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Little Rock, Arkansas, United States
Los Angeles, California, United States
Oakland, California, United States
Orange, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Wilmington, Delaware, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
South Bend, Indiana, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Omaha, Nebraska, United States
Morristown, New Jersey, United States
New Brunswick, New Jersey, United States
Brooklyn, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Providence, Rhode Island, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Madison, Wisconsin, United States
Petah Tikva, , Israel
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Munoz FM, Anderson EJ, Deville JG, Clinch B, Kamal MA. Pharmacokinetics and safety of intravenous oseltamivir in infants and children in open-label studies. Int J Clin Pharmacol Ther. 2015 Jul;53(7):531-40. doi: 10.5414/CP202307.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NP25138
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.