Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza

Completed · Phase 3

Conditions studied: Influenza

In brief

This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of 600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza infection and in subjects with acute uncomplicated influenza infection at higher risk for influenza complications. All subjects will receive IV peramivir.

Key facts

Study ID

NCT02635724

Run by

BioCryst Pharmaceuticals

People needed

74

Starts

2015-12-01

Expected to finish

2018-09-01

Last updated by the study team

2021-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A positive influenza Rapid Antigen Test (RAT) and/or a FDA-approved PCR test and at least one clinical sign or symptom consistent with acute influenza infection as listed below OR
• Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature ≥ 100°F (37.8°C) with at least one respiratory symptom of at least moderate severity (cough or rhinitis) and at least one constitutional symptom of at least moderate severity (myalgia [aches and pains], headache, feverishness, or fatigue)
• Influenza symptom onset < 48 hours. However, due to historically delayed presentation for medical care in the adult population, approximately 20% of the elderly population may be enrolled with symptoms starting > 48-hours but ≤ 72-hours

You may not qualify if…

• Women who plan to breast-feed for the first 48 hours after study drug administration
• Subjects requiring hospital admission to treat medical condition(s) which could represent complications of influenza.
• Recent worsening of any chronic medical condition consistent with complications of influenza
• Current evidence of a bacterial infection requiring antibiotic treatment

Where it is running

• Peramivir Investigational Site — Brooksville, Florida, United States
• Peramivir Investigational Site — Lakeland, Florida, United States
• Peramivir Investigational Site — Miami, Florida, United States
• Peramivir Investigational Site — St. Petersburg, Florida, United States
• Peramivir Investigational Site — Tampa, Florida, United States
• Peramivir investigative site — Indianapolis, Indiana, United States
• Peramivir investigative site — Detroit, Michigan, United States
• Peramivir Investigational Site — Dayton, Ohio, United States
• Peramivir investigative site — Smithfield, Pennsylvania, United States
• Peramivir Investigational Site — Houston, Texas, United States
• Peramivir Investigative Site — San Antonio, Texas, United States
• Peramivir investigative site — Splendora, Texas, United States
• Peramivir Investigational Site — Draper, Utah, United States
• Peramivir Investigational Site — Salt Lake City, Utah, United States
• Peramivir investigative site — South Jordan, Utah, United States

Full record on ClinicalTrials.gov

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