Peramivir Treatment Response in Adults Hospitalized for Influenza-associated Lower Respiratory Tract Infections

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014

Detailed Description

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.

Interventions

  • Drug: Peramivir
    • The two regimens of Peramivir were compared

Arms, Groups and Cohorts

  • Active Comparator: Peramivir 300mg Q12H
    • Peramivir 300 mg, administered intravenously, twice daily (every 12 hours)
  • Active Comparator: Peramivir 600mg Q24H
    • Peramivir 600 mg, administered intravenously, once daily (every 24 hrs)

Clinical Trial Outcome Measures

Primary Measures

  • change in influenza RNA load
    • Time Frame: 5 days
    • 5-10 days

Secondary Measures

  • viral shedding indicated by PCR and culture negativity
    • Time Frame: 5 days

Participating in This Clinical Trial

Inclusion Criteria

  • symptoms/signs of influenza, and – confirmation of lower respiratory tract infection (e.g. radiographic pneumonia, dyspnea caused by acute exacerbation of underlying airway diseases, bronchitis, or combinations). Exclusion Criteria:

  • late presentation >1 week from onset, – hemodynamic instability, – hepatic/renal failure, – dialysis, – immunosuppression (e.g. transplant, chemotherapy), and – pregnancy.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese University of Hong Kong
  • Collaborator
    • BioCryst Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof David Shu Cheong Hui, Professor – Chinese University of Hong Kong
  • Overall Official(s)
    • Nelson Lee, Principal Investigator, Chinese University of Hong Kong

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.