Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an Emergency IND program in the United States.

ABSTRACT:

Background

Peramivir, an investigational intravenous neuraminidase inhibitor in Phase 3 trials for hospitalized patients, was made available during the 2009 H1N1 influenza pandemic under the Emergency Investigational New Drug (eIND) regulations. We describe the clinical characteristics and outcomes of all patients for whom peramivir was requested under the eIND.

Methods

After obtaining eIND approval from the Food and Drug Administration and local institutional review board approval, clinicians caring for hospitalized patients with influenza administered intravenous peramivir and collected information on demographic characteristics, clinical characteristics, and outcomes.

Results

From April through October 2009, peramivir was requested for 42 patients and administered

SUBMITTER: Hernandez JE 

PROVIDER: S-EPMC3049340 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature