A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza

ClinicalTrials.gov ID: NCT01053663

Open the official record

This page only displays public information reproduced from the official ClinicalTrials.gov record NCT01053663. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Nov 15, 2026, 1:21 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir in the Treatment of Infants Less Than One Year of Age With Influenza Infection

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This open-label study will assess the pharmacokinetics and safety of oseltamivir \[Tamiflu\] in 3 cohorts of infants, aged 0-30 days, 31-90 days and 91-\<365 days with influenza infection. Patients will receive 10 doses of intravenous oseltamivir \[Tamiflu\] therapy over 5 or 6 days. Optional oral therapy with oseltamivir \[Tamiflu\] may be considered following the intravenous dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration. Anticipated time on study drug is 5-11 days. Target sample size is \<50 patients.

Study identification

NCT ID: NCT01053663
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 1
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 9 participants

Conditions and interventions

Conditions

Influenza

Interventions

Tamiflu Drug

Drug

Eligibility (public fields only)

Age range: Up to 365 Days
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 2011 (Type not available)
Primary completion: Jan 2013 (Actual)
Completion: Jan 2013 (Actual)
Last update posted: Jul 27, 2016

2011 – 2013

United States locations

U.S. sites: 38
U.S. states: 20
U.S. cities: 35

Facility	City	State	ZIP	Site status
Not listed	Little Rock	Arkansas	45229-3039	—
Not listed	Los Angeles	California	90095	—
Not listed	Oakland	California	94609-1809	—
Not listed	Orange	California	92868	—
Not listed	San Diego	California	92123	—
Not listed	Aurora	Colorado	80045	—
Not listed	Wilmington	Delaware	19803	—
Not listed	Jacksonville	Florida	32209	—
Not listed	Chicago	Illinois	60611	—
Not listed	South Bend	Indiana	46601	—
Not listed	Wichita	Kansas	67214	—
Not listed	Louisville	Kentucky	40202	—
Not listed	Boston	Massachusetts	02111	—
Not listed	Boston	Massachusetts	02115	—
Not listed	Boston	Massachusetts	02118	—
Not listed	Springfield	Massachusetts	01199	—
Not listed	Detroit	Michigan	48201	—
Not listed	Omaha	Nebraska	68131	—
Not listed	Morristown	New Jersey	07960	—
Not listed	New Brunswick	New Jersey	08901	—
Not listed	Brooklyn	New York	11203	—
Not listed	New York	New York	10016	—
Not listed	Stony Brook	New York	11794	—
Not listed	Syracuse	New York	13210	—
Not listed	The Bronx	New York	10461	—
Not listed	Durham	North Carolina	27705	—
Not listed	Raleigh	North Carolina	27610	—
Not listed	Akron	Ohio	44308	—
Not listed	Cleveland	Ohio	44106	—
Not listed	Dayton	Ohio	45404	—
Not listed	Toledo	Ohio	43606	—
Not listed	Toledo	Ohio	43608	—
Not listed	Providence	Rhode Island	02903	—
Not listed	Austin	Texas	78723	—
Not listed	Dallas	Texas	75390-9063	—
Not listed	Houston	Texas	77030	—
Not listed	Richmond	Virginia	23292	—
Not listed	Madison	Wisconsin	53792	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01053663, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 27, 2016 · Synced Nov 15, 2026