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Not Yet RecruitingPhase 2ACTRN12607000282482

To evaluate the effects on time to clinical stability associated with treatment with peramivir administered intravenously compared to oral oseltamivir in adults hospitalized with acute serious or potentially life-threatening influenza

A Phase II, Multicenter, Randomized, Double-Mask, Double-Dummy Study Comparing the Efficacy and Safety of Peramivir Administered Intravenously Once Daily versus Oseltamivir Administered Orally Twice Daily in Adults with Acute Serious or Potentially Life-Threatening Influenza. To evaluate the effects on time to clinical stability associated with treatment with peramivir administered intravenously compared to oral oseltamivir in adults hospitalized with acute serious or potentially life-threatening influenza

Sponsor

BioCryst Pharmaceuticals Inc.

Enrollment

120 participants

Start Date

Jun 10, 2007

Study Type

Interventional

Conditions

Life threatening comorbidities suchs as COPD, congestive heart failure and diabetes.Influenza

Summary

The primary purpose of this study is to evaluate how effective intra-venously administered Peramivir will be at reducing the symptoms assoicated with complicated Influenza. The success of the medication will be assessed through discussing outcomes with each patient and reviewing the blood samples provided. The Sponsor's of this study hypothesize that Peramivir intra-venously administered for 5 days will be effective at reducing the duration of influenza symptoms from about 100 hours to 80 hours from illness onset.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two antiviral treatments for influenza (the flu) in hospitalised adults. If you are 18 or older, have a fever and flu-like symptoms such as cough or sore throat, you may be eligible. Participants receive either an intravenous antiviral (peramivir) or an oral antiviral (oseltamivir) to see which helps you recover faster.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Subjects with signs and symptoms compatible with acute influenza infection will be evaluated for participation. Enrolled subjects will be randomized to receive one of three treatments: Treatment Gro

Subjects with signs and symptoms compatible with acute influenza infection will be evaluated for participation. Enrolled subjects will be randomized to receive one of three treatments: Treatment Group 1: Peramivir (BCX-1812) 200 mg, administered intravenously, once daily (q 24 hrs) for 5 days (5 doses) Treatment Group 2: Peramivir BCX-1812) 400 mg, administered intravenously, once daily (q 24 hrs) for 5 days (5 doses) Treatment Group 3: Oseltamivir 75 mg, ( oral suspension) administered per-oral, twice daily for 5 days (10 doses)

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