Clinical trial NCT00705406: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute, Uncomplicated Human Influenza
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 405
Sex: ALL
Minimum age (years): 18
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 whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.


Eligibility criteria: Inclusion Criteria:

* 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.

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.
* 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.
* Receipt of any intramuscular injection with the previous 7 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: Time to Alleviation of Symptoms (Kaplan-Meier Estimate)
timeFrame: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
Secondary outcomes:
measure: Change in Influenza Virus Shedding
timeFrame: Baseline and Days 3, 4, 9
Other outcomes:
measure: Subject's Severity of Illness (Score*Hours)
timeFrame: Information collected predose on Day 1 and then once daily through Day 14
measure: Time to Resolution of Fever
timeFrame: Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14
measure: Incidence of Influenza-related Complications
timeFrame: 14 days
measure: Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)
timeFrame: Baseline
measure: Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)
timeFrame: Baseline and up to 14 days
measure: Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)
timeFrame: Baseline and up to 14 days
measure: Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)
timeFrame: Baseline and up to 14 days
Locations:
city: Birmingham
country: United States
facility: West Alabama Research, Inc.
state: Alabama
city: Birmingham
country: United States
facility: Greystone Medical Research, LLC
state: Alabama
city: Phoenix
country: United States
facility: NextCare Institute for Clinical Research
state: Arizona
city: Jonesboro
country: United States
facility: Clopton Clinic
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Clinic
state: Arkansas
city: Mountain Home
country: United States
facility: North Central Arkansas Medical Associates
state: Arkansas
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: Carmichael
country: United States
facility: Medcenter
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: San Luis Obispo
country: United States
facility: Coastal Medical Research Group, Inc.
state: California
city: Boulder
country: United States
facility: Alpine Research Center
state: Colorado
city: Centennial
country: United States
facility: 1st Allergy and Clinical Research Center
state: Colorado
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research, Inc.
state: Florida
city: St. Cloud
country: United States
facility: Wilker/Powers Center for Clinical Studies, d/b/a ProHealth Clinical Studies
state: Florida
city: Columbus
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Savannah
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Woodstock
country: United States
facility: The Kaufmann Clinic, Inc.
state: Georgia
city: Idaho Falls
country: United States
facility: Idaho Falls Infectious Diseases
state: Idaho
city: Bloomingdale
country: United States
facility: Dr. Arthur Davida
state: Illinois
city: Indianapolis
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: Dubuque
country: United States
facility: Medical Associates Clinic
state: Iowa
city: Shawnee
country: United States
facility: Heart of America Research
state: Kansas
city: Hazard
country: United States
facility: Kentucky Lung Clinic
state: Kentucky
city: Baton Rouge
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: Bangor
country: United States
facility: Acadia Clinical Research
state: Maine
city: Clarksburg
country: United States
facility: Clarksburg Medical Center
state: Maryland
city: Brockton
country: United States
facility: Miray Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Receiving Hospital, UHC 6G
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: St. Claire Shores
country: United States
facility: KMED Research
state: Michigan
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Bozeman
country: United States
facility: Bozeman Urgent Care Center
state: Montana
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Fremont
country: United States
facility: Prairie Fields Family Medicine, P.C.
state: Nebraska
city: Las Vegas
country: United States
facility: Impact Clinical Trials, Las Vegas
state: Nevada
city: Johnson City
country: United States
facility: United Medical Associates
state: New York
city: Rochester
country: United States
facility: Twelve Corners Internal Medicine
state: New York
city: Greensboro
country: United States
facility: Bland Clinic
state: North Carolina
city: Canfield
country: United States
facility: Community Medical Associates, LLC
state: Ohio
city: Thornville
country: United States
facility: Advanced Health Care Services, Inc
state: Ohio
city: Owasso
country: United States
facility: Urgent Care of Green County, PLLC
state: Oklahoma
city: Ashland
country: United States
facility: Integrated Medical Research, PC
state: Oregon
city: Souderton
country: United States
facility: Pivotal Clinical Research, LLC
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research, Inc.
state: Rhode Island
city: Cumberland
country: United States
facility: Notheast Clinical Research
state: Rhode Island
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research, LLC
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Bryan
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Family Wellness Center, Research Division
state: Texas
city: Dallas
country: United States
facility: Allergy/Immunology Research Center of North Texas
state: Texas
city: Garland
country: United States
facility: Towngate Plaza Medical Center
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Medical Research Associates, LLC
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc., FirstMed
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./FirstMed East
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc./Foothill Family Clinic South
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Oregon
country: United States
facility: Dean Medical Center
state: Wisconsin
city: Blacktown
country: Australia
facility: Pacific Medical Centre Blacktown
state: New South Wales
city: Darlinghurst
country: Australia
facility: East Sydney Doctors
state: New South Wales
city: Hurtsville
country: Australia
facility: Symbion Pathology
state: New South Wales
city: Umina
country: Australia
facility: Peninsula Medical Centre
state: New South Wales
city: Auchenflower
country: Australia
facility: Rivercity Private Hospital Specialist
state: Queensland
city: Caboolture
country: Australia
facility: Caboolture Clinical Research Centre
state: Queensland
city: Kpparing
country: Australia
facility: Peninsula Specialist Centre
state: Queensland
city: Carlton
country: Australia
facility: Health Services -University of Melbourne
state: Victoria
city: Adelaide
country: Australia
facility: Athelstone Medical Clinic
city: Brisbane
country: Australia
facility: Trialworks Clinical Research Services
city: Burwood
country: Australia
facility: Dr Doongs Surgery
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice
city: Melbourne
country: Australia
facility: Doctors of Ivanhoe,
city: Nedlands
country: Australia
facility: Lung Institute of Western Australia,
city: Sydney
country: Australia
facility: Pitt Street Merrylands Medical Centre
city: Auckland
country: New Zealand
facility: Greenhithe Medical Centre
city: Christchurch
country: New Zealand
facility: St George's Hospital
city: Christchurch
country: New Zealand
facility: Southern Clinical Trials Ltd
city: Dunedin
country: New Zealand
facility: Caversham Medical Centre
city: Rotorua
country: New Zealand
facility: Bairds Road Family Health Care
city: Rotorua
country: New Zealand
facility: Dr. Gillies
city: Rotorua
country: New Zealand
facility: Hinemoa House Family Health Centre
city: Goodwood
country: South Africa
facility: Nortje, MD
state: Capetown
city: Greenbury
country: South Africa
facility: Greenbury Medical Centre
state: Durban
city: Silverglen
country: South Africa
facility: Sebastian, MD
state: Durban
city: Bloemfontein
country: South Africa
facility: Quinta-Research
state: Free State
city: Reigerpark
country: South Africa
facility: Wilhase, AC
state: Gauteg
city: Bryanston
country: South Africa
facility: NHC Medical Centre
state: Gauteng
city: Klipspruit West
country: South Africa
facility: R. Dulabh, MD
state: Gauteng
city: Noordheuwel
country: South Africa
facility: DJW Navorsing
state: Krugersdorp
city: Verulam
country: South Africa
facility: Pillay, MD
state: Kwa Zulu Natal
city: Durban
country: South Africa
facility: Vawda, Z.FA
state: KZ-Natal
city: Kempton Park
country: South Africa
facility: le Clus, MD
state: Pretoria
city: Sunnyside Pretoria
country: South Africa
facility: Sunnyside Medi-Clinic
state: Pretoria
city: Cape Town
country: South Africa
facility: Kaapzicht Centre
state: W. Cape
city: Cape Town
country: South Africa
facility: Syzygy SMO Intercare Medical and Dental Centre
state: W. Cape
city: Worcester
country: South Africa
facility: Clinical Project Research SA (Pty) Ltd.
state: W. Cape
city: Amanzimtoti
country: South Africa
facility: Dr. van Rensburg
city: Benoni
country: South Africa
facility: Benmed Park Clinic
city: Bloemfontein
country: South Africa
facility: Jsha Research
city: Brits
country: South Africa
facility: Armansis Medical Centre
city: Cape town
country: South Africa
facility: Cape Clinical Trial, Bishop Lavis Day Hospital
city: Cape Town
country: South Africa
facility: First House
city: Durban
country: South Africa
facility: Synapta Clinical Research Centre
city: Durban
country: South Africa
facility: Dr. Janari
city: Johannesburg
country: South Africa
facility: Dr. Makan
city: Johannesburg
country: South Africa
facility: Newgate Centre
city: Port Elizabeth
country: South Africa
facility: GCT Trials, Mercantile Hospital no 9
city: Pretoria
country: South Africa
facility: Dr. Nel
city: Pretoria
country: South Africa
facility: Emmed Research
city: Pretoria
country: South Africa
facility: Dr. de Bruin
city: Pretoria
country: South Africa
facility: Westmed Clinical Trial Centre, Pretoria West Medicross Building
city: Roodepoort
country: South Africa
facility: Dr. Fouche
city: Scottburgh
country: South Africa
facility: Dr. de Villiers
city: Soweto
country: South Africa
facility: Dr. Bhorat
city: Worcester
country: South Africa
facility: Clinical Projects Research SA Ltd
Study officials:
References: