Clinical trial NCT00610935: Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Subjects with uncomplicated acute influenza
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-08
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Time to Alleviation of Clinical Signs and Symptoms of Influenza
timeFrame: Up to 14 days
Secondary outcomes:
measure: To Evaluate Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
timeFrame: Change from baseline assessed on days 3, 5 and 9.
Other outcomes:
Locations:
city: Millbrook
country: United States
facility: Physical Express
state: Alabama
city: Tuscaloosa
country: United States
facility: Alabama Family Medical Center
state: Alabama
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Jonesboro
country: United States
facility: Clopton Clinic
state: Arkansas
city: Jonesboro
country: United States
facility: Research Solutions, LLC
state: Arkansas
city: Mountain Home
country: United States
facility: Kevin Adkins, MD
state: Arkansas
city: Anaheim
country: United States
facility: NuLife Clinical Research, Inc.
state: California
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: Buena Park
country: United States
facility: Associated Pharmaceutical Research Center, Inc.
state: California
city: Fair Oaks
country: United States
facility: Med Investigations Incorporated
state: California
city: Fresno
country: United States
facility: Universal Biopharma Research Institute Inc.
state: California
city: Fresno
country: United States
facility: Research Center of Fresno, Inc
state: California
city: Garden Grove
country: United States
facility: Harmony Clinical, Inc.
state: California
city: Long Beach
country: United States
facility: Allergy, Asthma, and Respiratory Care Medical Center
state: California
city: Los Angeles
country: United States
facility: National Institute of Clinical Research
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: San Diego
country: United States
facility: San Diego Sports Medicine and Family Health Center
state: California
city: San Luis Obispo
country: United States
facility: Coastal Medical Research Group, Inc.
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: Clinicos, LLC
state: Colorado
city: Longmont
country: United States
facility: Longmont Clinic, P.C.
state: Colorado
city: Gainesville
country: United States
facility: Florida Research Network, LLC
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Eastern Research
state: Florida
city: Holly Hill
country: United States
facility: Century Clinical Research Inc
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Office of Roger J. Miller, Jr., MD
state: Florida
city: Lake Worth
country: United States
facility: MD Now Medical Center
state: Florida
city: Largo
country: United States
facility: DMI Healthcare Group
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp.
state: Florida
city: Orlando
country: United States
facility: Compass Research LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Research, LLC
state: Florida
city: Saint Cloud
country: United States
facility: Wilker/Powers Center for Clinical Studies
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Sandersville
country: United States
facility: Sandersville Family Practice Center
state: Georgia
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Indianapolis
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: Newburgh
country: United States
facility: Welborn Clinic Gateway
state: Indiana
city: Dubuque
country: United States
facility: Medical Associates Clinic PC
state: Iowa
city: Shawnee Mission
country: United States
facility: Heart of America Research Institute
state: Kansas
city: Topeka
country: United States
facility: American Medical Exams, P.A.
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Hazard
country: United States
facility: Kentucky Lung Clinic
state: Kentucky
city: Whitley City
country: United States
facility: Winchester, Patton, Burgess, PSC
state: Kentucky
city: Baton Rouge
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: Lafayette
country: United States
facility: Gulf Coast Research LLC
state: Louisiana
city: Shreveport
country: United States
facility: Byron Jackson
state: Louisiana
city: Benzonia
country: United States
facility: Professional Clinical Research-Benzonia
state: Michigan
city: Cadillac
country: United States
facility: Professional Clinical Research, Inc.
state: Michigan
city: Interlochen
country: United States
facility: Professional Clinical Research-Interlochen
state: Michigan
city: Saint Clair Shores
country: United States
facility: KMED Research
state: Michigan
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: Bozeman
country: United States
facility: Clinical Research Department
state: Montana
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Fremont
country: United States
facility: Prarie Fields Family Medicine, P.C
state: Nebraska
city: Hamilton
country: United States
facility: Quick Care Medical
state: New Jersey
city: Elmira
country: United States
facility: Health Sciences Research Center at Asthma & Allergy Associates P.C.
state: New York
city: Ithaca
country: United States
facility: Health Sciences Research Center
state: New York
city: Raleigh
country: United States
facility: American Institute of Healthcare & Fitness
state: North Carolina
city: Canfield
country: United States
facility: Community Medical Partners
state: Ohio
city: Columbus
country: United States
facility: Parsons Avenue Medical Clinic
state: Ohio
city: Lyndhurst
country: United States
facility: Ohio Clinical Research LLC
state: Ohio
city: Edmond
country: United States
facility: Physician Care PM
state: Oklahoma
city: Owasso
country: United States
facility: Urgent Care of Green County
state: Oklahoma
city: Ashland
country: United States
facility: Integrated Medical Research PC
state: Oregon
city: Pittsburgh
country: United States
facility: Primary Physicians Research Inc.
state: Pennsylvania
city: Warminster
country: United States
facility: Warminster Medical Associates, PC
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research, Inc.
state: Rhode Island
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Greenville
country: United States
facility: Paris View Family Practice
state: South Carolina
city: Greenville
country: United States
facility: Andras Koser
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research, LLC
state: South Carolina
city: Spartanburg
country: United States
facility: S. Carolina Pharmaceutical Research
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group, PC
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group, P.C.
state: Tennessee
city: Beaumont
country: United States
facility: DiscoveResearch Inc.
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Corpus Christi
country: United States
facility: Intrinsic Research Data, Inc.
state: Texas
city: Dallas
country: United States
facility: Allergy/Immunology Research Center of North Texas
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Service
state: Texas
city: Houston
country: United States
facility: Dynamed Clinical Research, L.P.
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: GSA Research
state: Texas
city: San Antonio
country: United States
facility: San Antonio Preventive and Diagnostic Medicine
state: Texas
city: Salt Lake City
country: United States
facility: Optimum Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc. Foothill Family Clinic South
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc.
state: Utah
city: Saratoga Springs
country: United States
facility: Physicians Research Options, LLC
state: Utah
city: West Jordan
country: United States
facility: J. Lewis Research Inc. FirstMed
state: Utah
city: Richmond
country: United States
facility: Virginia Adult & Pediatric Allergy & Asthma, P.C Department of Clinical Research
state: Virginia
city: Weber City
country: United States
facility: Holston Medical Group
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
References: