Clinical trial NCT00957996: Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza
Official title: A Phase 3, Open-Label, Randomized Study of the Antiviral Activity, Safety, and Tolerability of Intravenous Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Influenza
Cough
Sore Throat
Nasal Congestion
Myalgia
Headache
Fatigue
Keywords: influenza
hospitalized
flu
antiviral
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2009-08-13
Enrollment: 234
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected influenza infection.


Eligibility criteria: Inclusion Criteria:

* Male and non-pregnant female subjects 6 years of age or older.
* Able to provide written informed consent, or for whom written consent may be provided by a parent guardian or legally authorized representative, unless consent provided by a parent, guardian or legally authorized representative is not consistent with applicable local or ethical procedures, directives and /or guidelines.
* Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection; a measured temperature of ≥ 38.0°C (100.4°F) oral, or ≥ 38.6°C (101.4°F) rectal or tympanic and recent onset of at least one of the following: rhinorrhea or nasal congestion, sore throat or cough. Measured temperature can include fever meeting the above criteria as reported by the subject or their parent, guardian or legally authorized representative in the 24 hours prior to Screening. The requirement for fever is waived for any subject with influenza infection already confirmed by laboratory tests (including Rapid Antigen Tests).
* Confirmation of influenza A or B infection in the local community by one of the following means:
* the institution's local laboratory,
* the local public health system
* the national public health system
* a laboratory of a recognized national or multinational influenza surveillance scheme.
* Severity of illness requiring or anticipated to require in-hospital care.

Exclusion Criteria:

* Subjects who have been hospitalized for greater than 24 hours (not including time spent in the emergency department).Blood platelet count of \< 20 x 109/L.
* Serum bilirubin \> 6 mg/dL at time of Screening evaluation.
* Serum ALT or AST \> 5 X upper limit of normal at time of Screening evaluation.
* Serum creatinine \> 5.0 mg/dL at time of Screening evaluation.
* Subjects who require peritoneal dialysis or hemofiltration.
* Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medically induced.
* Females who are pregnant (positive urine or serum pregnancy test at Screening evaluation) or breastfeeding.
* Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. (Subjects who have completed treatment 30 days prior to enrollment are allowed to enroll in the study. Hormone treatment for cancer is also acceptable).
* Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months.
* HIV infection with a known CD4 count \< 200 cells/ mm3 unless on a stable highly active antiretroviral (HAART) regimen for at least 6 months.
* Presence of a preexisting chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). (Subjects with chronic osteomyelitis or hepatitis B or C not requiring treatment are not excluded).
* Presence of any preexisting illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study.
* Participation as a subject in any study of an experimental treatment for any condition within the 30 days prior to the time of the Screening evaluation.
* Subjects diagnosed with cystic fibrosis.
* Subjects with confirmed clinical evidence of acute non-influenzal infection at the time of Screening.

Primary outcomes:
measure: Change From Baseline in Influenza Virus Titer (48 Hours)
timeFrame: Baseline and 48 hours
Secondary outcomes:
measure: Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)
timeFrame: Baseline, 48, 108, 216 hours
measure: Time to Clinical Resolution
timeFrame: 28 days
measure: Number of Participants With Clinical Resolution
timeFrame: 28 days
measure: Time to Alleviation of Symptoms
timeFrame: 28 days
measure: Time to Resolution of Fever
timeFrame: 28 days
measure: Time to Resumption of Usual Activities
timeFrame: 28 days
measure: Time to Hospital Discharge
timeFrame: 28 days
measure: Number of Participants Experiencing Influenza-related Complications
timeFrame: 28 days
measure: Number of Participants Admitted to ICU After Initiation of Treatment
timeFrame: 28 days
measure: Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate)
timeFrame: 28 days
measure: Survival (Kaplan-Meier Estimates)
timeFrame: 14 and 28 days
Other outcomes:
measure: Number of Participants Who Required More Than 5 Days of Peramivir Treatment
timeFrame: 28 days
Locations:
city: Dothan
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Fountain Valley
country: United States
state: California
city: Harbor City
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Modesto
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Orange
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Jose
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Brandon
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Gainsville
country: United States
state: Florida
city: Ocoee
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Rock Island
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Topeka
country: United States
state: Kansas
city: Hazard
country: United States
state: Kentucky
city: Natchitoches
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Englewood
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: Neptune
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Somers Point
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: New York
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Lima
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Brisbane
country: Australia
state: Queensland
city: Cairns
country: Australia
state: Queensland
city: Southport
country: Australia
state: Queensland
city: Clayton
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Kelowna
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Edmonton
country: Canada
city: Aguascalientes
country: Mexico
state: AGS
city: Distrito Federal
country: Mexico
state: DF
city: Guadalajara
country: Mexico
state: JAL
city: Zapopan
country: Mexico
state: JAL
city: Monterrey
country: Mexico
state: NL
city: San Luis Potosi
country: Mexico
state: SLP
city: Durango
country: Mexico
city: Auckland
country: New Zealand
state: Wellington
city: Christchurch
country: New Zealand
city: Hamilton
country: New Zealand
city: Tauranga
country: New Zealand
city: San Juan
country: Puerto Rico
Study officials:
References:
citation: Ison MG, Fraiz J, Heller B, Jauregui L, Mills G, O'Riordan W, O'Neil B, Playford EG, Rolf JD, Sada-Diaz E, Elder J, Collis P, Hernandez JE, Sheridan WP. Intravenous peramivir for treatment of influenza in hospitalized patients. Antivir Ther. 2014;19(4):349-61. doi: 10.3851/IMP2680. Epub 2013 Aug 28.