A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza
2 other identifiers
interventional
405
4 countries
123
Brief Summary
The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2008
Shorter than P25 for phase_2
123 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2008
CompletedFirst Posted
Study publicly available on registry
June 26, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
February 16, 2015
CompletedFebruary 16, 2015
February 1, 2015
9 months
June 24, 2008
January 16, 2015
February 12, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.
Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
Secondary Outcomes (1)
Change in Influenza Virus Shedding
Baseline and Days 3, 4, 9
Other Outcomes (7)
Subject's Severity of Illness (Score*Hours)
Information collected predose on Day 1 and then once daily through Day 14
Time to Resolution of Fever
Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
Incidence of Influenza-related Complications
14 days
- +4 more other outcomes
Study Arms (2)
Peramivir 600 mg
EXPERIMENTAL600 mg peramivir administered as bilateral 2-mL intramuscular injection.
Placebo
PLACEBO COMPARATORPlacebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
Interventions
Eligibility Criteria
You may qualify if:
- Male and non-pregnant female subjects age ≥18 years.
- A positive Influenza A 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 36 hours before presentation for screening.
- Written informed consent.
You may not qualify if:
- 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.
- History of heart failure or angina 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (123)
West Alabama Research, Inc.
Birmingham, Alabama, 35209, United States
Greystone Medical Research, LLC
Birmingham, Alabama, 35242, United States
NextCare Institute for Clinical Research
Phoenix, Arizona, 85016, United States
Clopton Clinic
Jonesboro, Arkansas, 72401, United States
NEA Clinic
Jonesboro, Arkansas, 72401, United States
North Central Arkansas Medical Associates
Mountain Home, Arkansas, 72653, United States
Impact Clinical Trials
Beverly Hills, California, 90211, United States
Medcenter
Carmichael, California, 95608, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
Coastal Medical Research Group, Inc.
San Luis Obispo, California, 93405, United States
Alpine Research Center
Boulder, Colorado, 80304, United States
1st Allergy and Clinical Research Center
Centennial, Colorado, 80112, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
DMI Research, Inc.
Pinellas Park, Florida, 33782, United States
Wilker/Powers Center for Clinical Studies, d/b/a ProHealth Clinical Studies
Saint Cloud, Florida, 34769, United States
Southeast Regional Research Group
Columbus, Georgia, 31904, United States
Southeast Regional Research Group
Savannah, Georgia, 31406, United States
The Kaufmann Clinic, Inc.
Woodstock, Georgia, 30188, United States
Idaho Falls Infectious Diseases
Idaho Falls, Idaho, 83404, United States
Dr. Arthur Davida
Bloomingdale, Illinois, 60108, United States
Investigators Research Group, LLC
Indianapolis, Indiana, 46268, United States
Medical Associates Clinic
Dubuque, Iowa, 52001, United States
Heart of America Research
Shawnee, Kansas, 66218, United States
Kentucky Lung Clinic
Hazard, Kentucky, 41701, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, 70808, United States
Acadia Clinical Research
Bangor, Maine, 44401, United States
Clarksburg Medical Center
Clarksburg, Maryland, 20871, United States
Miray Medical Center
Brockton, Massachusetts, 02301, United States
Detroit Receiving Hospital, UHC 6G
Detroit, Michigan, 48201, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
KMED Research
Saint Claire Shores, Michigan, 48081, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Bozeman Urgent Care Center
Bozeman, Montana, 59715, United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
Prairie Fields Family Medicine, P.C.
Fremont, Nebraska, 68025, United States
Impact Clinical Trials, Las Vegas
Las Vegas, Nevada, 89106, United States
United Medical Associates
Johnson City, New York, 13790, United States
Twelve Corners Internal Medicine
Rochester, New York, 14618, United States
Bland Clinic
Greensboro, North Carolina, 27401, United States
Community Medical Associates, LLC
Canfield, Ohio, 44515, United States
Advanced Health Care Services, Inc
Thornville, Ohio, 43076, United States
Urgent Care of Green County, PLLC
Owasso, Oklahoma, 74055, United States
Integrated Medical Research, PC
Ashland, Oregon, 97520, United States
Pivotal Clinical Research, LLC
Souderton, Pennsylvania, 18964, United States
New England Center for Clinical Research, Inc.
Cranston, Rhode Island, 02920, United States
Notheast Clinical Research
Cumberland, Rhode Island, 02864, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, 29681, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
DiscoveResearch, Inc.
Bryan, Texas, 77802, United States
Corpus Christi Family Wellness Center, Research Division
Corpus Christi, Texas, 78414, United States
Allergy/Immunology Research Center of North Texas
Dallas, Texas, 75230, United States
Towngate Plaza Medical Center
Garland, Texas, 75041, United States
West Houston Clinical Research
Houston, Texas, 77055, United States
Texas Medical Research Associates, LLC
San Antonio, Texas, 78238, United States
Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
J. Lewis Research, Inc., FirstMed
Salt Lake City, Utah, 84088, United States
J. Lewis Research, Inc./Foothill Family Clinic South
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc./FirstMed East
Salt Lake City, Utah, 84121, United States
J. Lewis Research, Inc./Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Dean Medical Center
Oregon, Wisconsin, 53575, United States
Pacific Medical Centre Blacktown
Blacktown, New South Wales, 2148, Australia
East Sydney Doctors
Darlinghurst, New South Wales, 2010, Australia
Symbion Pathology
Hurtsville, New South Wales, 2220, Australia
Peninsula Medical Centre
Umina, New South Wales, 2257, Australia
Rivercity Private Hospital Specialist
Auchenflower, Queensland, 4066, Australia
Caboolture Clinical Research Centre
Caboolture, Queensland, 4510, Australia
Peninsula Specialist Centre
Kpparing, Queensland, 4021, Australia
Health Services -University of Melbourne
Carlton, Victoria, 3053, Australia
Athelstone Medical Clinic
Adelaide, 5076, Australia
Trialworks Clinical Research Services
Brisbane, Australia
Dr Doongs Surgery
Burwood, Australia
Holdsworth House Medical Practice
Darlinghurst, Australia
Doctors of Ivanhoe,
Melbourne, Australia
Lung Institute of Western Australia,
Nedlands, Australia
Pitt Street Merrylands Medical Centre
Sydney, Australia
St George's Hospital
Christchurch, Christchurch, 4737, New Zealand
Bairds Road Family Health Care
Rotorua, Rotorua, 3010, New Zealand
Greenhithe Medical Centre
Auckland, New Zealand
Southern Clinical Trials Ltd
Christchurch, New Zealand
Caversham Medical Centre
Dunedin, New Zealand
Dr. Gillies
Rotorua, New Zealand
Hinemoa House Family Health Centre
Rotorua, New Zealand
Jsha Research
Bloemfontein, Bloemfontein, 9301, South Africa
Nortje, MD
Goodwood, Capetown, 7460, South Africa
Greenbury Medical Centre
Greenbury, Durban, 4068, South Africa
Sebastian, MD
Silverglen, Durban, 4092, South Africa
Quinta-Research
Bloemfontein, Free State, 9301, South Africa
Wilhase, AC
Reigerpark, Gauteg, 1459, South Africa
NHC Medical Centre
Bryanston, Gauteng, 2191, South Africa
R. Dulabh, MD
Klipspruit West, Gauteng, 1812, South Africa
DJW Navorsing
Noordheuwel, Krugersdorp, 1739, South Africa
Pillay, MD
Verulam, KwaZulu-Natal, 4340, South Africa
Vawda, Z.FA
Durban, KZ-Natal, 4091, South Africa
le Clus, MD
Kempton Park, Pretoria, 1619, South Africa
Sunnyside Medi-Clinic
Sunnyside Pretoria, Pretoria, 0132, South Africa
Kaapzicht Centre
Cape Town, W. Cape, 7500, South Africa
Syzygy SMO Intercare Medical and Dental Centre
Cape Town, W. Cape, 7530, South Africa
Clinical Project Research SA (Pty) Ltd.
Worcester, W. Cape, 6850, South Africa
Benmed Park Clinic
Benoni, 1501, South Africa
Armansis Medical Centre
Brits, 0250, South Africa
Cape Clinical Trial, Bishop Lavis Day Hospital
Cape Town, 7490, South Africa
First House
Cape Town, 7941, South Africa
Synapta Clinical Research Centre
Durban, 4001, South Africa
Dr. Janari
Durban, South Africa
Dr. van Rensburg
eManzimtoti, 4126, South Africa
Dr. Makan
Johannesburg, 1820, South Africa
Newgate Centre
Johannesburg, South Africa
GCT Trials, Mercantile Hospital no 9
Port Elizabeth, South Africa
Dr. Nel
Pretoria, 0083, South Africa
Emmed Research
Pretoria, 0084, South Africa
Dr. de Bruin
Pretoria, 9585, South Africa
Westmed Clinical Trial Centre, Pretoria West Medicross Building
Pretoria, South Africa
Dr. Fouche
Roodepoort, 1724, South Africa
Dr. de Villiers
Scottburgh, 4182, South Africa
Dr. Bhorat
Soweto, 1818, South Africa
Clinical Projects Research SA Ltd
Worcester, 6850, South Africa
MeSH Terms
Interventions
Limitations and Caveats
The majority of the subjects enrolled in this study with a laboratory confirmed influenza infection were infected with an influenza A/H1N1 virus containing an H275Y mutation associated with reduced susecptibility to peramivir and oseltamivir.
Results Point of Contact
- Title
- William P. Sheridan, MBBS
- Organization
- BioCryst Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2008
First Posted
June 26, 2008
Study Start
July 1, 2008
Primary Completion
April 1, 2009
Study Completion
October 1, 2009
Last Updated
February 16, 2015
Results First Posted
February 16, 2015
Record last verified: 2015-02