A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza
Public ClinicalTrials.gov record NCT01053663. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. 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
- Enrollment
- 9 participants
Conditions and interventions
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
- Dec 31, 2010
- Primary completion
- Dec 31, 2012
- Completion
- Dec 31, 2012
- Last update posted
- Jul 26, 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 26, 2016 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01053663 live on ClinicalTrials.gov.