AI114373: A Phase III international, randomized, doubleblind, double-dummy study to evaluate the efficacy and safety of 300 mg or 600 mg of intravenous zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza (NAI114373)
- Conditions
- fluinfluenza10047438
- Registration Number
- NL-OMON36811
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 8
• Male or female aged >=16 years (in the Netherlands: 18 years and above).
• 3 or more of the following criteria at Baseline:
o Temperature >= 38,5oC rectal (alternative methods: see protocol) with 2 exceptions (see protocol for details).
o Arterial oxygen saturation <95%.
o Respiration rate >24 breaths per minute.
o HR >100 bpm.
o SBP <90 mmHg.
• Onset of influenza symptoms within 6 days prior to study enrolment.
• Confirmed influenza as determined by a positive RAT for influenza A or B, or a laboratory test for influenza. Subjects with a negative RAT or other test may be enrolled based on strong clinical suspicion of influenza.
• Safe contraception for women of childbearing potential.
• Breastfeeding, pregnancy.
• Subjects who have taken more than a total of 6 doses of approved anti-influenza therapy.
• Life expectancy less than 48 hours.
• Treatment with investigational parenteral anti-influenza drugs in the 4 weeks prior to Baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to clinical response in subjects with confirmed influenza.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Include a series of clinical efficacy, virologic, PK and safety endpoints.</p><br>