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High-Dose vs Standard-Dose Oseltamivir for Severe Influenza
NCT00298233Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2006
- Primary completion
- Jan 2010
- Countries
- 3
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- Small Molecules
- Drugs
- oseltamivir
- Conditions
- influenzaAvian Influenza (AI)
01
Overview
Phase 2, randomised, double-blind trial of oseltamivir in influenza and Avian Influenza (AI) (4 arms), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoint: Proportion of All Participants Negative for Viral RNA on Day 5. Started Feb 2006; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Standard Dose Adult
Oseltamivir 75 mg BID
Double Dose Adult
Oseltamivir 150 mg BID
Standard Dose Child
Oseltamivir 75 mg equivalent BID
Double Dose Child
Oseltamivir 150 mg equivalent BID
03
Who it enrols
Hospitalized patients with severe influenza or avian influenza (H5N1), including adults and children. Requires respiratory symptoms and either radiographic infiltrate, severe tachypnea/dyspnea, or hypoxia. Excludes those with significant prior oseltamivir use or severe renal impairment.
04
Endpoints
Primary
Proportion of All Participants Negative for Viral RNA on Day 5
Secondary
Participants Meeting Criteria for Day 5 Clinical Failure
In-hospital Mortality Rates
Median Time (Days) Receipt of Oxygen
Median Time (Days) in ICU
Median Time (Days) on Ventilation
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