Clinical trial NCT01224795: A Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.
Official title: A Phase III, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Influenza
Keywords: uncomplicated influenza
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2010-10-20
Enrollment: 1
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute uncomplicated influenza.

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute,uncomplicated influenza.

Eligibility criteria: Inclusion Criteria:

* Male and non-pregnant female subjects age ≥12 years.
* Test positive for influenza A or B by Rapid Antigen Test (RAT) performed with a commercially available test on an adequate anterior nasal specimen in accordance with the manufacturer's instructions.
* 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/assent.

Exclusion Criteria:

* Women who are pregnant or breast-feeding.
* Employees of the study site, or immediate family members of study site employees.
* 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.
* 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 media,bronchitis, sinusitis and/or pneumonia, or active bacterial infection of 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 ic treatment with \> 10 mg prednisone or equivalent on a daily basis within 30 days of screening.
* Presence of known HIV infection with a CD4 count \<350 cell/mm3.
* Receipt of any dose of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening.
* Immunization against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 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 exposure to peramivir.
* Participation in a study of any investigational drug or device within the last 30 days.
* Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
* Presence of any pre-existing illness that in the opinion of the investigator would make the subject unable to comply with the protocol.

Primary outcomes:
measure: To evaluate the efficacy of peramivir administered intravenously compared to placebo on the time to alleviation of clinical symptoms with acute uncomplicated influenza.
timeFrame: 14 Days
Secondary outcomes:
measure: To evaluate the safety and tolerability of peramivir administered intravenously
timeFrame: 14 Days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Mountain Home
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Chino
country: United States
state: California
city: Dinuba
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Lincoln
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Port Hueneme
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Tustin
country: United States
state: California
city: West Covina
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Centennial
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Milford
country: United States
state: Connecticut
city: Brooksville
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Cutler Bay
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Edgewater
country: United States
state: Florida
city: Gainsville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Stockbridge
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Aurora
country: United States
state: Illinois
city: Bloomingdale
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: South Bend
country: United States
state: Indiana
city: Dubuque
country: United States
state: Iowa
city: Arkansas City
country: United States
state: Kansas
city: Lenexa
country: United States
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: Hazard
country: United States
state: Kentucky
city: Paducah
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Hollywood
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Fall River
country: United States
state: Massachusetts
city: Washington
country: United States
state: Missouri
city: Bozeman
country: United States
state: Montana
city: Fremont
country: United States
state: Nebraska
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: Camillus
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Akron
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Wadsworth
country: United States
state: Ohio
city: Owasso
country: United States
state: Oklahoma
city: Bend
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Hatfield
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Scotland
country: United States
state: Pennsylvania
city: Cranston
country: United States
state: Rhode Island
city: Cumberland
country: United States
state: Rhode Island
city: Johnston
country: United States
state: Rhode Island
city: Easley
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Bryan
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Forth Worth
country: United States
state: Texas
city: Georgetown
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: North Richland Hills
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Spring
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Arlington
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
Study officials:
References: