Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00391768 · ClinicalTrials.gov registry record · Phase 1
Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
- 20
- Study locations
NCT00391768 is a Phase 1 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 87 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT00391768, a Phase 1 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG oseltamivir (Tamiflu®)
Study Locations (20)
California
- Miller Children's Hospital Long Beach - Bickerstaff Family Center - Long Beach
- Children's Hospital of Orange County - Orange
- Rady Children's Hospital San Diego - San Diego
New York
- Cohen Children's Medical Center - Pediatric Infectious Diseases - Manhasset
- University of Rochester - Rochester
- SUNY Upstate Medical University Hospital - Pediatrics - Syracuse
Florida
- University of Florida - Shands Children's Hospital - Gainesville
- University of South Florida - Tampa General Hospital - Pediatrics - Tampa
Georgia
- Emory Children's Center - Pediatric Infectious Diseases - Atlanta
- Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases - Atlanta
Ohio
- Cincinnati Children's Hospital Medical Center - Infectious Diseases - Cincinnati
- MetroHealth Medical Center - Pediatric Infectious Disease - Cleveland
Alabama
- University of Alabama at Birmingham - Birmingham
Arkansas
- Arkansas Children's Hospital - Infectious Diseases - Little Rock
Colorado
- Children's Hospital Colorado - Infectious Disease - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2007-01 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00391768
The ClinicalTrials.gov registry entry for NCT00391768 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which oseltamivir (Tamiflu®) is the first listed.
NCT00391768 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT00391768 about?
NCT00391768 is a clinical study titled "Oseltamivir Treatment for Children Less Than 24 Months of Age With Influenza". 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 ...
What is the current status of trial NCT00391768?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2007-01. Estimated completion is 2010-04.
What conditions does trial NCT00391768 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00391768?
The interventions under investigation include: oseltamivir (Tamiflu®) (DRUG).
Who is sponsoring clinical trial NCT00391768?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00391768 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
pH1N1 Blinded Challenge Study
RECRUITING · Phase 1
-
A/Texas Flu Challenge
RECRUITING · Phase 1
-
First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics
RECRUITING · Phase 1
-
Influenza Human Challenge Model
RECRUITING · Phase 1
-
A Study to Evaluate the Safety and Immunogenicity of Two Doses of DCVC H1 HA mRNA-LNP in Healthy Adults
ACTIVE NOT RECRUITING · Phase 1
-
Pilot Influenza Challenge Study
ACTIVE NOT RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.