Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza
NCT ID: NCT00610935
Last Updated: 2021-03-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
82 participants
INTERVENTIONAL
2008-01-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo intramuscular injection
Placebo
Single intramuscular injection
Peramivir
Single intramuscular injection of 300mg peramivir
Peramivir
To evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza.
Interventions
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Peramivir
To evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza.
Placebo
Single intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* A positive Influenza A and/or B Rapid Antigen Test (RAT) performed with a commercially available test kit on an adequate anterior nasal specimen, in accordance with the manufacturer's instructions. A negative initial RAT should be repeated within one-hour.
* Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. A subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at the time of screening.
* Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity.
* Presence of at least one constitutional symptom (myalgia \[aches and pains\], headache, feverishness, or fatigue) of at least moderate severity.
* Onset of symptoms no more than 48 hours before presentation for screening.
* Written informed consent.
Exclusion Criteria
* Presence of clinically significant signs of acute respiratory distress.
* History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma (See section 15.2).
* History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months.
* Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia.
* History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance \<50 mL/min).
* Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the investigator's opinion, indicates that such finding(s) could represent complications of influenza.
* Current clinical evidence, including clinical signs and/or symptoms consistent with otitis, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at any body site that requires therapy with oral or systemic antibiotics.
* Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with \> 10 mg prednisone or equivalent on a daily basis within 30 days of screening.
* Currently receiving treatment for viral hepatitis B or viral hepatitis C.
* Presence of known HIV infection with a CD4 count \<350 cell/mm3.
* Current therapy with oral warfarin or other systemic anticoagulant.
* Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening.
* Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days.
* Immunized against influenza with inactivated virus vaccine within the previous 14 days.
* Receipt of any intramuscular injection within the previous 14 days.
* History of alcohol abuse or drug addiction within 1 year prior to admission in the study.
* Participation in a previous study of intramuscular or intravenous peramivir or previous participation in this study.
* Participation in a study of any investigational drug or device within the last 30 days.
18 Years
75 Years
ALL
No
Sponsors
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BioCryst Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Physical Express
Millbrook, Alabama, United States
Alabama Family Medical Center
Tuscaloosa, Alabama, United States
HOPE Research Institute
Phoenix, Arizona, United States
Clopton Clinic
Jonesboro, Arkansas, United States
Research Solutions, LLC
Jonesboro, Arkansas, United States
Kevin Adkins, MD
Mountain Home, Arkansas, United States
NuLife Clinical Research, Inc.
Anaheim, California, United States
Impact Clinical Trials
Beverly Hills, California, United States
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, United States
Med Investigations Incorporated
Fair Oaks, California, United States
Universal Biopharma Research Institute Inc.
Fresno, California, United States
Research Center of Fresno, Inc
Fresno, California, United States
Harmony Clinical, Inc.
Garden Grove, California, United States
Allergy, Asthma, and Respiratory Care Medical Center
Long Beach, California, United States
National Institute of Clinical Research
Los Angeles, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
San Diego Sports Medicine and Family Health Center
San Diego, California, United States
Coastal Medical Research Group, Inc.
San Luis Obispo, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Clinicos, LLC
Colorado Springs, Colorado, United States
Longmont Clinic, P.C.
Longmont, Colorado, United States
Florida Research Network, LLC
Gainesville, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
Eastern Research
Hialeah, Florida, United States
Century Clinical Research Inc
Holly Hill, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Office of Roger J. Miller, Jr., MD
Jacksonville, Florida, United States
MD Now Medical Center
Lake Worth, Florida, United States
DMI Healthcare Group
Largo, Florida, United States
Well Pharma Medical Research, Corp.
Miami, Florida, United States
Compass Research LLC
Orlando, Florida, United States
Pines Research, LLC
Pembroke Pines, Florida, United States
Wilker/Powers Center for Clinical Studies
Saint Cloud, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Sandersville Family Practice Center
Sandersville, Georgia, United States
Quincy Medical Group
Quincy, Illinois, United States
Investigators Research Group, LLC
Indianapolis, Indiana, United States
Welborn Clinic Gateway
Newburgh, Indiana, United States
Medical Associates Clinic PC
Dubuque, Iowa, United States
Heart of America Research Institute
Shawnee Mission, Kansas, United States
American Medical Exams, P.A.
Topeka, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Kentucky Lung Clinic
Hazard, Kentucky, United States
Winchester, Patton, Burgess, PSC
Whitley City, Kentucky, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, United States
Gulf Coast Research LLC
Lafayette, Louisiana, United States
Byron Jackson
Shreveport, Louisiana, United States
Professional Clinical Research-Benzonia
Benzonia, Michigan, United States
Professional Clinical Research, Inc.
Cadillac, Michigan, United States
Professional Clinical Research-Interlochen
Interlochen, Michigan, United States
KMED Research
Saint Clair Shores, Michigan, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Clinvest
Springfield, Missouri, United States
Clinical Research Department
Bozeman, Montana, United States
Mercury Street Medical Group, PLLC
Butte, Montana, United States
Prarie Fields Family Medicine, P.C
Fremont, Nebraska, United States
Quick Care Medical
Hamilton, New Jersey, United States
Health Sciences Research Center at Asthma & Allergy Associates P.C.
Elmira, New York, United States
Health Sciences Research Center
Ithaca, New York, United States
American Institute of Healthcare & Fitness
Raleigh, North Carolina, United States
Community Medical Partners
Canfield, Ohio, United States
Parsons Avenue Medical Clinic
Columbus, Ohio, United States
Ohio Clinical Research LLC
Lyndhurst, Ohio, United States
Physician Care PM
Edmond, Oklahoma, United States
Urgent Care of Green County
Owasso, Oklahoma, United States
Integrated Medical Research PC
Ashland, Oregon, United States
Primary Physicians Research Inc.
Pittsburgh, Pennsylvania, United States
Warminster Medical Associates, PC
Warminster, Pennsylvania, United States
New England Center for Clinical Research, Inc.
Cranston, Rhode Island, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Paris View Family Practice
Greenville, South Carolina, United States
Andras Koser
Greenville, South Carolina, United States
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, United States
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, United States
Holston Medical Group, PC
Bristol, Tennessee, United States
Holston Medical Group, P.C.
Kingsport, Tennessee, United States
DiscoveResearch Inc.
Beaumont, Texas, United States
DiscoveResearch, Inc.
Bryan, Texas, United States
Intrinsic Research Data, Inc.
Corpus Christi, Texas, United States
Allergy/Immunology Research Center of North Texas
Dallas, Texas, United States
Research Across America
Dallas, Texas, United States
West Houston Clinical Research Service
Houston, Texas, United States
Dynamed Clinical Research, L.P.
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
GSA Research
San Antonio, Texas, United States
San Antonio Preventive and Diagnostic Medicine
San Antonio, Texas, United States
Optimum Clinical Research
Salt Lake City, Utah, United States
J. Lewis Research Inc
Salt Lake City, Utah, United States
J. Lewis Research Inc. Foothill Family Clinic South
Salt Lake City, Utah, United States
J. Lewis Research, Inc.
Salt Lake City, Utah, United States
Physicians Research Options, LLC
Saratoga Springs, Utah, United States
J. Lewis Research Inc. FirstMed
West Jordan, Utah, United States
Virginia Adult & Pediatric Allergy & Asthma, P.C Department of Clinical Research
Richmond, Virginia, United States
Holston Medical Group
Weber City, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HHS # O100200700032C
Identifier Type: REGISTRY
Identifier Source: secondary_id
BCX1812 311
Identifier Type: -
Identifier Source: org_study_id
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