Influenza Clinical Trial
Official title:
A Phase 2, Pilot, Open-label, Randomized Study of the Antiviral Activity, Safety, and Tolerability of Intravenous Peramivir in Adult Hospitalized Subjects With Confirmed Influenza Infection
Peramivir is the first intravenous neuraminidase inhibitor (NAI) available for treatment of
uncomplicated influenza in adults. Data from placebo-controlled trials in outpatients have
shown antiviral efficacy, safety, and tolerability. Although the unmet need for intravenous
therapy lies mainly with patients hospitalized with complicated diseases, such data are
limited because of feasibility and ethical considerations for placebo-controlled studies.
In this study, the investigators aimed to examine more specifically treatment effects of
peramivir in adults hospitalized with influenza-associated lower respiratory tract
complications (LRTC). Such findings may have important implications on clinical management.
The primary objective was to assess the virologic response of peramivir in
influenza-associated lower respiratory tract complications (LRTC). The secondary objective
was to assess safety and tolerability. Adults confirmed with influenza by polymerase chain
reaction (PCR) and/or immunofluorescence assays during the seasonal peaks of 2011-2014 were
assessed for eligibility. Consented individuals were randomized to receive either peramivir
600mg every 24 hourly or 300mg every 12 hourly for 5 days. In subjects not achieving
clinical resolution by day 5, the same regimen could be continued until day 10 (virologic
results unknown to clinicians).Renal-dosage adjustment, if required, was performed according
to protocol.
The study's primary endpoint was change in influenza RNA load over time. The secondary
endpoints were viral shedding indicated by culture and RNA negativity at day 5, and drug
tolerability.
Additionally, a priori comparisons of these endpoints with historical controls treated with
standard courses of oral oseltamivir (75mg bid for 5 days) in the same clinical settings
were performed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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