Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.

Summary

This is a study for patients with flu who also have a fever as well as other flu symptoms. Patients must have had symptoms for less than 48 hours in order to participate. Patients will have two out of three chances of getting an active study treatment and the other third will receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to be seen 5 more times after they are enrolled in the study.

Conditions

• Influenza

Interventions

DRUG

Peramivir 150 mg

Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).

DRUG

Peramivir 300 mg

Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).

DRUG

Placebo

Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).

Sponsors & Collaborators

• BioCryst Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Stanley Block, MD · Kentucky Pediatric/Adult Research

• James Borders, MD · Central Kentucky Research Assoc, Inc

• Robert Broker, MD · Hillcrest Family Practice

• Paul Browstone, MD · Alpine Clinical Research Center

• Jeffry Jacqmein, MD · Jacksonville Center For Clinical Research

• Isaac Marcadis, MD · Palm Beach Research Center

• Mark Stich, MD · Jacksonville Center For Clinical Research

• George Atiee, MD · GSA Research

• Joe Blumenau, MD · Research Across America

• John Champlin, MD · Medical Center

• Shane Christensen, MD · J. Lewis Research, Inc. Foothill Family Clinic South

• Steven Duckor, MD · Advanced Clinical Research Institute

• Lewis Eirinberg, MD · Midwest Family Physicians

• Milton K. Erman, MD · Pacific Sleep Medicine Services

• Stanley Cohen, MD · Radiant Research

• David L. Fried, MD · Omega Medical Research

• Yury Furman, MD · Pacific Sleep Medicine Services, Inc.

• Wayne Harper, MD · Wake Research Associates, LLC

• Dan C Henry, MD · J. Lewis Research, Inc. Foothill Family Clinic

• John M. Hill, MD · University Clinical Research-Deland, LLC

• Veryl Hodges, DO · Clopton Clinic

• Reuben Holland, III, MD · Clinical Research Center

• William Jennings, MD · Radiant Research San Antonio

• James Edmond Kelaher, MD,MPH · Baylor Clinic-Baylor College of Medicine

• Allan Kelly, MD · Hermitage Medicentres

• Ben Lasko, MD · Manna Research

• Mark Leber, MD · The Brooklyn Hospital Center

• Larissa Lim, MD · Florida Medical Research Institute

• Alain Martel, MD · Clinique medicale des Campus

• Dennis Mikolich, MD · Paragon Clinical Research, Inc.

• Julie Mullen, MD · Sterling Research Group, LTD.

• David Parenti, MD · George Washington University

• Monica Pierson, MD · Radiant Research

• Robert Poirier, MD · Barnes-Jewish Hospital Emergency Department

• Ivan Rarick, MD · Benchmark Research

• Dennis Riff, MD · Advanced Clinical Research Institute

• Q Rizvi, MD · Castledowns Medicentre

• Michael Rokeach, MD · Pacific Sleep Medicine Services

• Rawle Seupaul, MD · Wishard Hospital

• Daniel Shu, MD · Gain Medical Research Centre

• Steve Sitar, MD · Orange County Clinical Trials

• Kirk Stiffler, MD · Summa Emergency Associates Inc.

• Guy Tellier, MD · Omnispec clinical research Inc

• Michael Warren, MD · Research Across America at Oyster Point Family Health Center

• Randall Watson, MD · J. Lewis Research, Inc./Southwest Family Medicine

• John Michael Wise, MD · Bozeman Urgent Care Center

• Chivers Woodruff, Jr., MD · Radiant Research

• Bruce Berwald, MD · Radiant Research

• Frank Maggiacomo, DO · New England Center for Clinical Research, Inc

• Barry Packman, MD · Radiant Research

• Sheila Rodstein, MD · Radiant Research, Minneapolis

• Bernardo Ng, MD · Pacific Sleep Medicines Service

• Gerardo Losoya, MD · Towngate Plaza Medical Center

• Francis X. Burch, MD · Radiant Research-San Antonio Northeast

• John P. Delgado, MD · Integrated Medical Research, PC

• Edward Fein, MD · Pulmonary & Critical Care Associates

• Bruce D. Forney, MD · Alliance Medical Center

• James E. Greenwald, MD · Medex Healthcare Research, Inc.

• Robert Hudrick, DO · University of Medicine & Dentistry of New Jersey

• Robert Jeanfreau, MD · Benchmark Research

• Robert Kaufmann, MD · Georgia Clinical Research

• Sy Lam, MD · Calgary West Medical Centre Clinical Studies

• Keith S. Reisinger, MD, MPH · Primary Physicians Research, Inc

• Keith S. Reisinger, MD, MPH · Family Practice Medical Associates South

• Earl Martin, MD · Dynamed Clinical Research

• Jean-Sebastien Gauthier, MD · Q & T Research Inc.

• Jeffrey Rosen, MD · Clinical Research of Southern Florida

• Gerald Burns, MD · New Orleans Medical

• Stewart Behiel, MD · Belvedere Medicentre

• Giuseppe D'Ignazio, MD · Source Unique Clinic

• Indravadan Dattani, MD · Prairie Clinical

• Roy A. Gritter, MD · RJA Medicentres

• Balbir Chahal, MD · Balbir Chahal M.D. ,P.A.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2007-09-30

Completion

2007-09-30

Countries

• United States
• Canada

Study Locations