Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza
- Registration Number
- NCT00610935
- Lead Sponsor
- BioCryst Pharmaceuticals
- Brief Summary
The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 82
- Male and non-pregnant female subjects age ≥18 years.
- 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.
- Women who are pregnant or breast-feeding.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo intramuscular injection Peramivir Peramivir Single intramuscular injection of 300mg peramivir
- Primary Outcome Measures
Name Time Method The Time to Alleviation of Clinical Signs and Symptoms of Influenza Up to 14 days The primary efficacy endpoint was the time to alleviation of symptoms of influenza in subjects diagnosed with influenza, defined as the time from injection of study drug to the start of the time period when a subject had Alleviation of Symptoms. A subject had Alleviation of Symptoms if each of the seven symptoms of influenza (cough, sore throat, nasal obstruction, myalgia \[aches and pains\], headache, feverishness, and fatigue) as self-assessed and recorded in the subject diary were either absent or were present at no more than mild severity level and at this status for at least 21.5 hours (24 hours minus 10%). No statistical testing was performed.
- Secondary Outcome Measures
Name Time Method To Evaluate Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment. Change from baseline assessed on days 3, 5 and 9. The change in influenza viral titers was defined as the time-weighted change from Baseline in log_10 tissue culture infective dose_50 (TCID50/mL) and was summarized for each treatment group. The differences between the treatment groups were planned to be evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID50/mL were obtained at interval visits after treatment. As the study was terminated prematurely, no statistical testing was performed on these data.
Trial Locations
- Locations (95)
Clopton Clinic
🇺🇸Jonesboro, Arkansas, United States
Kevin Adkins, MD
🇺🇸Mountain Home, Arkansas, United States
Integrated Medical Research PC
🇺🇸Ashland, Oregon, United States
Andras Koser
🇺🇸Greenville, South Carolina, United States
J. Lewis Research Inc. FirstMed
🇺🇸West Jordan, Utah, United States
West Houston Clinical Research Service
🇺🇸Houston, Texas, United States
Dynamed Clinical Research, L.P.
🇺🇸Houston, Texas, United States
Physical Express
🇺🇸Millbrook, Alabama, United States
Research Solutions, LLC
🇺🇸Jonesboro, Arkansas, United States
Physician Care PM
🇺🇸Edmond, Oklahoma, United States
Ohio Clinical Research LLC
🇺🇸Lyndhurst, Ohio, United States
Med Investigations Incorporated
🇺🇸Fair Oaks, California, United States
Urgent Care of Green County
🇺🇸Owasso, Oklahoma, United States
New England Center for Clinical Research, Inc.
🇺🇸Cranston, Rhode Island, United States
NuLife Clinical Research, Inc.
🇺🇸Anaheim, California, United States
Holston Medical Group, P.C.
🇺🇸Kingsport, Tennessee, United States
Paris View Family Practice
🇺🇸Greenville, South Carolina, United States
Hillcrest Clinical Research, LLC
🇺🇸Simpsonville, South Carolina, United States
Warminster Medical Associates, PC
🇺🇸Warminster, Pennsylvania, United States
Physicians Research Options, LLC
🇺🇸Saratoga Springs, Utah, United States
S. Carolina Pharmaceutical Research
🇺🇸Spartanburg, South Carolina, United States
Intrinsic Research Data, Inc.
🇺🇸Corpus Christi, Texas, United States
San Diego Sports Medicine and Family Health Center
🇺🇸San Diego, California, United States
Well Pharma Medical Research, Corp.
🇺🇸Miami, Florida, United States
Investigators Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Universal Biopharma Research Institute Inc.
🇺🇸Fresno, California, United States
Associated Pharmaceutical Research Center, Inc.
🇺🇸Buena Park, California, United States
Impact Clinical Trials
🇺🇸Beverly Hills, California, United States
Allergy, Asthma, and Respiratory Care Medical Center
🇺🇸Long Beach, California, United States
Research Center of Fresno, Inc
🇺🇸Fresno, California, United States
Parsons Avenue Medical Clinic
🇺🇸Columbus, Ohio, United States
Primary Physicians Research Inc.
🇺🇸Pittsburgh, Pennsylvania, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
DiscoveResearch Inc.
🇺🇸Beaumont, Texas, United States
DiscoveResearch, Inc.
🇺🇸Bryan, Texas, United States
Allergy/Immunology Research Center of North Texas
🇺🇸Dallas, Texas, United States
Research Across America
🇺🇸Dallas, Texas, United States
Holston Medical Group
🇺🇸Weber City, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
GSA Research
🇺🇸San Antonio, Texas, United States
Sun Research Institute
🇺🇸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
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Alabama Family Medical Center
🇺🇸Tuscaloosa, Alabama, United States
Harmony Clinical, Inc.
🇺🇸Garden Grove, California, United States
National Institute of Clinical Research
🇺🇸Los Angeles, California, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States
Coastal Medical Research Group, Inc.
🇺🇸San Luis Obispo, California, United States
Clinicos, LLC
🇺🇸Colorado Springs, Colorado, United States
Longmont Clinic, P.C.
🇺🇸Longmont, Colorado, United States
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
Eastern Research
🇺🇸Hialeah, Florida, United States
Century Clinical Research Inc
🇺🇸Holly Hill, Florida, United States
Office of Roger J. Miller, Jr., MD
🇺🇸Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
MD Now Medical Center
🇺🇸Lake Worth, Florida, United States
DMI Healthcare Group
🇺🇸Largo, Florida, United States
Pines Research, LLC
🇺🇸Pembroke Pines, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Wilker/Powers Center for Clinical Studies
🇺🇸Saint Cloud, Florida, United States
Sandersville Family Practice Center
🇺🇸Sandersville, Georgia, United States
Quincy Medical Group
🇺🇸Quincy, Illinois, 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
Kentucky Lung Clinic
🇺🇸Hazard, Kentucky, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, 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
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
Florida Research Network, LLC
🇺🇸Gainesville, Florida, United States
Compass Research LLC
🇺🇸Orlando, Florida, United States
Virginia Adult & Pediatric Allergy & Asthma, P.C Department of Clinical Research
🇺🇸Richmond, Virginia, United States
Holston Medical Group, PC
🇺🇸Bristol, Tennessee, United States
Clinical Research Department
🇺🇸Bozeman, Montana, United States