A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza

Last updated: January 28, 2015
Sponsor: BioCryst Pharmaceuticals
Overall Status: Terminated

Phase

3

Condition

Pain (Pediatric)

Fever

Pain

Treatment

N/A

Clinical Study ID

NCT00958776
BCX1812-301
  • Ages > 12
  • All Genders

Study Summary

A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of peramivir administered intravenously in addition to standard of care compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥12 years of age, male or female.

  • Able to provide informed consent, or for whom consent may be provided by guardian,unless informed consent provided by a guardian or a legally authorized representativeis not consistent with applicable local or ethical concerns, procedures, directivesand/or guidelines.

  • Subject must have at least one of the following clinical presentations at Screening:

  1. Oral temperature ≥ 38.0 °C (≥100.4 °F), ≥38.6°C (≥101.4 °F) tympanic or rectal OR

  2. Oxygen saturation <92%, OR

  3. Two out of the following three vital signs: Respiration rate >24/minute, Heart rate >100/minute, Systolic BP <90 mmHg

  • Presence of at least one respiratory symptom (cough, sore throat, or nasal congestion)of any severity (mild, moderate, or severe).

  • Presence of at least one constitutional symptom (headache, myalgia, feverishness, orfatigue) of any severity (mild, moderate, or severe).

  • Onset of illness no more than 72 hours before presentation. Note: Time of onset ofillness is defined as the earlier of either (1) the time when the temperature wasfirst measured as elevated, OR (2) the time when the subject experienced the presenceof at least one respiratory symptom AND the presence of at least one constitutionalsymptom.

  • Either: Severity of illness that, in the Investigator's judgment, justifies hospitalization of thesubject for supportive care. OR Presence of one or more of the following factors: Age ≥60 years. Presence of chronic obstructive pulmonary disease (COPD) or other chroniclung disease requiring daily pharmacotherapy. Current history of congestive heart failure or angina. Presence of diabetes mellitus,clinically stable or unstable. Transcutaneous oxygen saturation <94% without supplementaloxygen for at least 5 minutes, or a medically significant decrease in oxygen saturationfrom an established baseline value (an investigative site at altitude >2000 ft above sealevel will utilize different criteria for oxygen saturation). History of chronic renal impairment not requiring peritoneal dialysis. Serum creatinine > 2.0 mg/dL or > 177 μmol/L.

  • Diagnosis of Influenza by satisfying one of the following:

  1. Clinical Influenza with Positive Diagnostic Test. Subjects who have a positiverapid antigen test (RAT) for influenza A and/or influenza B (using aSponsor-approved test kit), or positive test (using other methodology) forinfluenza A and/or B virus antigen or RNA performed in a clinical laboratory atthe screening/enrollment evaluation are eligible for enrollment. OR

  2. Clinical Influenza with Negative Rapid Antigen Test (RAT). Subjects with anegative RAT test may be enrolled once the site has been approved by the Sponsorto enroll such subjects, based on documentation of an outbreak of influenza inthe community. An influenza outbreak may be documented in the catchment area ofthe hospital via one of the following methods: 1) local confirmation of influenzaA or B infection in the current influenza season by a) the institution's locallaboratory, or b) the local public health system, or c) the national publichealth system, or d) a laboratory of a recognized multinational influenzasurveillance scheme such as the European Influenza Surveillance Network (EISN);

  1. prior enrollment of a RAT positive subject into this study at the sameinstitution in the current influenza season.

Exclusion

Exclusion Criteria:

  • Subjects who have been hospitalized for greater than 24 hours (not including timespent in the Emergency Department).

  • Treatment with any dose(s) of rimantadine, amantadine, ribavirin, zanamivir, oroseltamivir in the previous 7 days.

  • Blood platelet count of < 20 x 109/L at the time of the screening evaluation.

  • Serum bilirubin > 6 mg/dL or > 105 μmol/L at time of screening evaluation.

  • Serum ALT or AST > 5 times the upper limit of normal at time of screening evaluation.

  • Congestive heart failure of NYHA Class III or Class IV functional status.

  • Serum creatinine > 5.0 mg/dL or > 500 μmol/L at time of screening evaluation.

  • Subjects who require peritoneal dialysis.

  • Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medicallyinduced.

  • Females who are pregnant (positive urine or serum pregnancy test at screeningevaluation) or breastfeeding.

  • Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy.Subjects who have completed treatment 30 days prior to enrollment are not excluded.Hormone treatment for cancer is also not excluded.

  • Prior hematopoietic stem cell transplantation or solid organ transplant during theprevious 4 months.

  • HIV infection with a known CD4 count < 200 cells/mm3 unless on a stable highly activeantiretroviral therapy (HAART) for at least 6 months.

  • Presence of a pre-existing chronic infection that is undergoing or requiring medicaltherapy (eg, tuberculosis). Subjects with chronic osteomyelitis or Hepatitis B or Cnot requiring treatment are not excluded.

  • Presence of any pre-existing illness that, in the opinion of the investigator, wouldplace the subject at an unreasonably increased risk through participation in thisstudy.

  • Previous treatment with intravenous or intramuscular peramivir.

  • Participation as a subject in any study of an experimental treatment for any conditionwithin 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 thetime of screening evaluation.

  • Subjects who, in the judgment of the investigator, will be unlikely to comply with therequirements of this protocol.

Study Design

Total Participants: 405
Study Start date:
November 01, 2009
Estimated Completion Date:
October 31, 2013

Connect with a study center

  • Hospital del Torax Dr. Antonio A. Cetrangolo

    Buenos Aires, 1638
    Argentina

    Site Not Available

  • Buenos Aires,
    Argentina

    Site Not Available

  • Caba,
    Argentina

    Site Not Available

  • Cordoba,
    Argentina

    Site Not Available

  • Mendoza,
    Argentina

    Site Not Available

  • Merlo,
    Argentina

    Site Not Available

  • Rosario,
    Argentina

    Site Not Available

  • Santa Fe,
    Argentina

    Site Not Available

  • Vicente Lopez,
    Argentina

    Site Not Available

  • empty

    Brussels,
    Belgium

    Site Not Available

  • Bruxelles,
    Belgium

    Site Not Available

  • empty

    Leuven,
    Belgium

    Site Not Available

  • Liege,
    Belgium

    Site Not Available

  • Mons,
    Belgium

    Site Not Available

  • Sarajevo,
    Bosnia and Herzegovina

    Site Not Available

  • Tuzla,
    Bosnia and Herzegovina

    Site Not Available

  • Belo Horizonte, MG
    Brazil

    Site Not Available

  • Curitiba, PR
    Brazil

    Site Not Available

  • Passo Fundo, RS
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, RS 90035-903
    Brazil

    Site Not Available

  • Porto Alegre, RS
    Brazil

    Site Not Available

  • Campinas, SP
    Brazil

    Site Not Available

  • Santo Andre, SP
    Brazil

    Site Not Available

  • Santos, SP
    Brazil

    Site Not Available

  • Sao Paulo, SP
    Brazil

    Site Not Available

  • Plovdiv,
    Bulgaria

    Site Not Available

  • DDPPDI - Ruse

    Ruse, 7002
    Bulgaria

    Site Not Available

  • Fifth MHAT-Sofia, AD

    Sofia, 1233
    Bulgaria

    Site Not Available

  • MHAT - Tokuda Hospital Sofia, AD

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Military Medical Academy - MHAT

    Sofia, 1606
    Bulgaria

    Site Not Available

  • Sofia,
    Bulgaria

    Site Not Available

  • MHAT - Tokuda Hospital Sofia, AD

    Stara Zagora,
    Bulgaria

    Site Not Available

  • MHAT 'Dr. St. Cherkezov', AD

    Veliko Tarnovo, 5000
    Bulgaria

    Site Not Available

  • Kelowna, British Columbia
    Canada

    Site Not Available

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Kingston, Ontario
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • Chicoutimi, Quebec
    Canada

    Site Not Available

  • empty

    Montreal, Quebec
    Canada

    Site Not Available

  • Sherbrooke, Quebec
    Canada

    Site Not Available

  • Quebec,
    Canada

    Site Not Available

  • Hospital Clinico Regional Dr. Guillermo Grant Benavente

    Concepcion,
    Chile

    Site Not Available

  • Hosp. de Urgencia Asistencia Publica Dr. Alejandro del Rio

    Santiago, 56 2 5681332
    Chile

    Site Not Available

  • Santiago,
    Chile

    Site Not Available

  • Temuco,
    Chile

    Site Not Available

  • Fakultni nemocnice Brno

    Brno, 625 00
    Czech Republic

    Site Not Available

  • Hradec Kralove,
    Czech Republic

    Site Not Available

  • Praha,
    Czech Republic

    Site Not Available

  • Tabor,
    Czech Republic

    Site Not Available

  • Krajska zdravotni, a.s. - Masarykova nemocnice v Ustinad La

    Usti nad Labem, 401 13
    Czech Republic

    Site Not Available

  • Berlin,
    Germany

    Site Not Available

  • Erlangen,
    Germany

    Site Not Available

  • Goettingen,
    Germany

    Site Not Available

  • Koeln,
    Germany

    Site Not Available

  • Mainz,
    Germany

    Site Not Available

  • Universitaetsklinikum Regensburg

    Regensburg, 93053
    Germany

    Site Not Available

  • Debrecen,
    Hungary

    Site Not Available

  • Fehergyarmat,
    Hungary

    Site Not Available

  • Fejer Megyei Szent Gyorgy Korhaz

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Principal SMO Dr. Bugyi Istvan Korhaz Szentes

    Szentes, 6000
    Hungary

    Site Not Available

  • Zalaegerszeg,
    Hungary

    Site Not Available

  • Hyderabad, Andhra Pradesh
    India

    Site Not Available

  • Secunderabad, Andhra Pradesh
    India

    Site Not Available

  • Ahmedabad, Gujarat
    India

    Site Not Available

  • Karamsad, Gujarat
    India

    Site Not Available

  • Surat, Gujarat
    India

    Site Not Available

  • Vadodara, Gujarat
    India

    Site Not Available

  • Faridabad, Haryana
    India

    Site Not Available

  • empty

    Mansarovar, Jaipur
    India

    Site Not Available

  • Srinagar, Jammu & Kashmir
    India

    Site Not Available

  • Bangalore, Karnataka
    India

    Site Not Available

  • Mangalore, Karnataka
    India

    Site Not Available

  • Ernakulam, Kerala
    India

    Site Not Available

  • empty

    Kochi, Kerala
    India

    Site Not Available

  • Thrissur, Kerala
    India

    Site Not Available

  • Trivandrum, Kerala
    India

    Site Not Available

  • Cherthala, Maharashtra
    India

    Site Not Available

  • Mumbai, Maharashtra
    India

    Site Not Available

  • Nagpur, Maharashtra
    India

    Site Not Available

  • Nashik, Maharashtra
    India

    Site Not Available

  • Pune, Maharashtra
    India

    Site Not Available

  • empty

    Ludhiana, Punjab
    India

    Site Not Available

  • Mohali, Punjab
    India

    Site Not Available

  • Bikaner, Rajasthan
    India

    Site Not Available

  • Fortis Escort Hospital

    Jaipur, Rajasthan 302017
    India

    Site Not Available

  • Apollo First Med Hospitals

    Chennai, Tamil Nadu 600010
    India

    Site Not Available

  • Life Line Multispecialty Hospital

    Chennai, Tamil Nadu 600096
    India

    Site Not Available

  • Chennai, Tamil Nadu
    India

    Site Not Available

  • Coimbatore, Tamil Nadu
    India

    Site Not Available

  • Lucknow, Uttar Pradesh
    India

    Site Not Available

  • Kolkata, West Bengal
    India

    Site Not Available

  • Delhi,
    India

    Site Not Available

  • Afula,
    Israel

    Site Not Available

  • Haifa,
    Israel

    Site Not Available

  • Holon,
    Israel

    Site Not Available

  • Jerusalem,
    Israel

    Site Not Available

  • Kfar Saba,
    Israel

    Site Not Available

  • empty

    Petah-Tikva,
    Israel

    Site Not Available

  • Ramat Gan,
    Israel

    Site Not Available

  • Tel Aviv,
    Israel

    Site Not Available

  • Liepaja,
    Latvia

    Site Not Available

  • Rezekne,
    Latvia

    Site Not Available

  • Valmiera,
    Latvia

    Site Not Available

  • Ventspils,
    Latvia

    Site Not Available

  • Beirut,
    Lebanon

    Site Not Available

  • Arequipa,
    Peru

    Site Not Available

  • Cuzco,
    Peru

    Site Not Available

  • Lima,
    Peru

    Site Not Available

  • Bydgoszcz,
    Poland

    Site Not Available

  • Lancut,
    Poland

    Site Not Available

  • Lodz,
    Poland

    Site Not Available

  • Mielec,
    Poland

    Site Not Available

  • Poznan,
    Poland

    Site Not Available

  • Pulawy,
    Poland

    Site Not Available

  • Engels,
    Russian Federation

    Site Not Available

  • Niznhy Novgorod,
    Russian Federation

    Site Not Available

  • Novosibirsk,
    Russian Federation

    Site Not Available

  • empty

    Saratov,
    Russian Federation

    Site Not Available

  • St. Petersburg,
    Russian Federation

    Site Not Available

  • Tomsk,
    Russian Federation

    Site Not Available

  • Belgrade,
    Serbia

    Site Not Available

  • Kragujevac,
    Serbia

    Site Not Available

  • Nis,
    Serbia

    Site Not Available

  • Novi Sad,
    Serbia

    Site Not Available

  • empty

    Bratislava,
    Slovakia

    Site Not Available

  • empty

    Nitra,
    Slovakia

    Site Not Available

  • empty

    Roznava,
    Slovakia

    Site Not Available

  • Trnava,
    Slovakia

    Site Not Available

  • Middelburg, Mpumalanga
    South Africa

    Site Not Available

  • Bloemfontein,
    South Africa

    Site Not Available

  • Dundee,
    South Africa

    Site Not Available

  • Durban,
    South Africa

    Site Not Available

  • Krugersdorp,
    South Africa

    Site Not Available

  • Limpopo,
    South Africa

    Site Not Available

  • Port Elizabeth,
    South Africa

    Site Not Available

  • Pretoria,
    South Africa

    Site Not Available

  • Somerset West,
    South Africa

    Site Not Available

  • Worcester,
    South Africa

    Site Not Available

  • Chernivci,
    Ukraine

    Site Not Available

  • Donetsk,
    Ukraine

    Site Not Available

  • Kharkiv,
    Ukraine

    Site Not Available

  • Kyiv,
    Ukraine

    Site Not Available

  • Odesa,
    Ukraine

    Site Not Available

  • Poltava,
    Ukraine

    Site Not Available

  • Sumy,
    Ukraine

    Site Not Available

  • Vinnytsya,
    Ukraine

    Site Not Available

  • Leicester,
    United Kingdom

    Site Not Available

  • La Mesa, California
    United States

    Site Not Available

  • Long Beach, California
    United States

    Site Not Available

  • Modesto, California
    United States

    Site Not Available

  • Oceanside, California
    United States

    Site Not Available

  • Pulmonary Consultants PC Physicians Medical Group, Inc.

    Orange, California 92868
    United States

    Site Not Available

  • Orange, California
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Sharp Chula Vista Medical Center

    San Diego, California 91911
    United States

    Site Not Available

  • San Diego, California
    United States

    Site Not Available

  • Denver, Colorado
    United States

    Site Not Available

  • Drogue Medical, LLC

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Washington Hospital Center CAR

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Washington, District of Columbia
    United States

    Site Not Available

  • empty

    Brandon, Florida
    United States

    Site Not Available

  • Ft. Lauderdale, Florida
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • Orlando, Florida
    United States

    Site Not Available

  • West Palm Beach, Florida
    United States

    Site Not Available

  • Florida Hospital

    Winter Park, Florida 32790-2706
    United States

    Site Not Available

  • Columbus, Georgia
    United States

    Site Not Available

  • DeKalb Medical Center

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Savannah, Georgia
    United States

    Site Not Available

  • Honolulu, Hawaii
    United States

    Site Not Available

  • Medical Arts Associates, Ltd.

    Moline, Illinois 61265
    United States

    Site Not Available

  • Springfield, Illinois
    United States

    Site Not Available

  • South Bend, Indiana
    United States

    Site Not Available

  • Kentucky Lung Clinic

    Hazard, Kentucky 41701
    United States

    Site Not Available

  • Natchitoches, Louisiana
    United States

    Site Not Available

  • New Orleans, Louisiana
    United States

    Site Not Available

  • Annapolis, Maryland
    United States

    Site Not Available

  • Baltimore, Maryland
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Wayne State University - Hutzel Hospital

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Wayne State University, Department of Emergency Medicine

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Detroit, Michigan
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • William Beaumont Hospital

    Troy, Michigan 48085
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • St. Louis, Missouri
    United States

    Site Not Available

  • Las Vegas, Nevada
    United States

    Site Not Available

  • New Brunswick, New Jersey
    United States

    Site Not Available

  • empty

    Albany, New York
    United States

    Site Not Available

  • Bronx, New York
    United States

    Site Not Available

  • Manhasset, New York
    United States

    Site Not Available

  • empty

    Mineola, New York
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill AIDS Clinical Trials Unit

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Remington-Davis, Inc.

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Dayton, Ohio
    United States

    Site Not Available

  • Kettering, Ohio
    United States

    Site Not Available

  • Regional Infection Diseases Infusion Center Inc.

    Lima, Ohio 45801
    United States

    Site Not Available

  • ID Clinical Research, LTD

    Toledo, Ohio 43608
    United States

    Site Not Available

  • Medical College Of Ohio

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Toledo, Ohio
    United States

    Site Not Available

  • Allentown, Pennsylvania
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • East Providence, Rhode Island
    United States

    Site Not Available

  • Charleston, South Carolina
    United States

    Site Not Available

  • Sioux Falls, South Dakota
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • empty

    Norfolk, Virginia
    United States

    Site Not Available

  • Carilion Infectious Disease

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • VA Medical Center - Salem

    Salem, Virginia 24153
    United States

    Site Not Available

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