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

NCT ID: NCT00958776

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-10-31

Brief 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.

Conditions

Cough; Sore Throat; Nasal Congestion; Headache; Fever; Seasonal Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Peramivir+SOC

• Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
• Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Group Type: EXPERIMENTAL

Peramivir+SOC

Intervention Type: DRUG

• Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
• Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Placebo+SOC

Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Group Type: PLACEBO_COMPARATOR

Placebo+SOC

Intervention Type: DRUG

Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Interventions

Peramivir+SOC

• Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
• Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Intervention Type: DRUG

Placebo+SOC

Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.

Intervention Type: DRUG

Eligibility Criteria

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 representative is not consistent with applicable local or ethical concerns, procedures, directives and/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, or fatigue) of any severity (mild, moderate, or severe).
• Onset of illness no more than 72 hours before presentation. Note: Time of onset of illness is defined as the earlier of either (1) the time when the temperature was first measured as elevated, OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
• Either:

Severity of illness that, in the Investigator's judgment, justifies hospitalization of the subject 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 chronic lung 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 supplemental oxygen for at least 5 minutes, or a medically significant decrease in oxygen saturation from an established baseline value (an investigative site at altitude >2000 ft above sea level 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 positive rapid antigen test (RAT) for influenza A and/or influenza B (using a Sponsor-approved test kit), or positive test (using other methodology) for influenza A and/or B virus antigen or RNA performed in a clinical laboratory at the screening/enrollment evaluation are eligible for enrollment.

OR

2. Clinical Influenza with Negative Rapid Antigen Test (RAT). Subjects with a negative RAT test may be enrolled once the site has been approved by the Sponsor to enroll such subjects, based on documentation of an outbreak of influenza in the community. An influenza outbreak may be documented in the catchment area of the hospital via one of the following methods: 1) local confirmation of influenza A or B infection in the current influenza season by a) the institution's local laboratory, or b) the local public health system, or c) the national public health system, or d) a laboratory of a recognized multinational influenza surveillance scheme such as the European Influenza Surveillance Network (EISN); 2) prior enrollment of a RAT positive subject into this study at the same institution in the current influenza season.

Exclusion Criteria

• Subjects who have been hospitalized for greater than 24 hours (not including time spent in the Emergency Department).
• Treatment with any dose(s) of rimantadine, amantadine, ribavirin, zanamivir, or oseltamivir 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 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 not excluded. Hormone treatment for cancer is also not excluded.
• 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 therapy (HAART) for at least 6 months.
• Presence of a pre-existing 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 pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
• Previous treatment with intravenous or intramuscular peramivir.
• 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 evaluation.
• Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

BioCryst Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Curitiba, Paraná, Brazil

Passo Fundo, Rio Grande do Sul, Brazil

La Mesa, California, United States

Long Beach, California, United States

Modesto, California, United States

Oceanside, California, United States

Pulmonary Consultants PC Physicians Medical Group, Inc.

Orange, California, United States

Orange, California, United States

UC Davis Medical Center

Sacramento, California, United States

Sharp Chula Vista Medical Center

San Diego, California, United States

San Diego, California, United States

Denver, Colorado, United States

Drogue Medical, LLC

Wheat Ridge, Colorado, United States

Washington Hospital Center CAR

Washington D.C., District of Columbia, United States

Washington D.C., District of Columbia, United States

Fort Lauderdale, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

West Palm Beach, Florida, United States

Florida Hospital

Winter Park, Florida, United States

Columbus, Georgia, United States

DeKalb Medical Center

Decatur, Georgia, United States

Savannah, Georgia, United States

Honolulu, Hawaii, United States

Medical Arts Associates, Ltd.

Moline, Illinois, United States

Springfield, Illinois, United States

South Bend, Indiana, United States

Kentucky Lung Clinic

Hazard, Kentucky, United States

Natchitoches, Louisiana, United States

New Orleans, Louisiana, United States

Annapolis, Maryland, United States

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Wayne State University - Hutzel Hospital

Detroit, Michigan, United States

Wayne State University, Department of Emergency Medicine

Detroit, Michigan, United States

Detroit, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

William Beaumont Hospital

Troy, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

St Louis, Missouri, United States

Las Vegas, Nevada, United States

New Brunswick, New Jersey, United States

Manhasset, New York, United States

New York, New York, United States

The Bronx, New York, United States

University of North Carolina at Chapel Hill AIDS Clinical Trials Unit

Chapel Hill, North Carolina, United States

Remington-Davis, Inc.

Columbus, Ohio, United States

Dayton, Ohio, United States

Kettering, Ohio, United States

Regional Infection Diseases Infusion Center Inc.

Lima, Ohio, United States

ID Clinical Research, LTD

Toledo, Ohio, United States

Medical College Of Ohio

Toledo, Ohio, United States

Toledo, Ohio, United States

Allentown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

East Providence, Rhode Island, United States

Charleston, South Carolina, United States

Sioux Falls, South Dakota, United States

San Antonio, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Carilion Infectious Disease

Roanoke, Virginia, United States

VA Medical Center - Salem

Salem, Virginia, United States

Hospital del Torax Dr. Antonio A. Cetrangolo

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Caba, , Argentina

Córdoba, , Argentina

Mendoza, , Argentina

Merlo, , Argentina

Rosario, , Argentina

Santa Fe, , Argentina

Vicente López, , Argentina

Brussels, , Belgium

Liège, , Belgium

Mons, , Belgium

Sarajevo, , Bosnia and Herzegovina

Tuzla, , Bosnia and Herzegovina

Belo Horizonte, Minas Gerais, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Campinas, São Paulo, Brazil

Santo André, São Paulo, Brazil

Santos, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Plovdiv, , Bulgaria

DDPPDI - Ruse

Rousse, , Bulgaria

Fifth MHAT-Sofia, AD

Sofia, , Bulgaria

MHAT - Tokuda Hospital Sofia, AD

Sofia, , Bulgaria

Military Medical Academy - MHAT

Sofia, , Bulgaria

Sofia, , Bulgaria

MHAT - Tokuda Hospital Sofia, AD

Stara Zagora, , Bulgaria

MHAT 'Dr. St. Cherkezov', AD

Veliko Tarnovo, , Bulgaria

Kelowna, British Columbia, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Kingston, Ontario, Canada

Toronto, Ontario, Canada

Chicoutimi, Quebec, Canada

Québec, Quebec, Canada

Sherbrooke, Quebec, Canada

Hospital Clinico Regional Dr. Guillermo Grant Benavente

Concepción, , Chile

Hosp. de Urgencia Asistencia Publica Dr. Alejandro del Rio

Santiago, , Chile

Santiago, , Chile

Temuco, , Chile

Fakultni nemocnice Brno

Brno, , Czechia

Hradec Králové, , Czechia

Prague, , Czechia

Tábor, , Czechia

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

Ústí nad Labem, , Czechia

Berlin, , Germany

Cologne, , Germany

Erlangen, , Germany

Göttingen, , Germany

Mainz, , Germany

Universitaetsklinikum Regensburg

Regensburg, , Germany

Debrecen, , Hungary

Fehérgyarmat, , Hungary

Principal SMO Dr. Bugyi Istvan Korhaz Szentes

Szentes, , Hungary

Fejer Megyei Szent Gyorgy Korhaz

Székesfehérvár, , Hungary

Zalaegerszeg, , Hungary

Hyderabad, Andhra Pradesh, India

Secunderabad, Andhra Pradesh, India

Ahmedabad, Gujarat, India

Karamsad, Gujarat, India

Surat, Gujarat, India

Vadodara, Gujarat, India

Faridabad, Haryana, India

Srinagar, Jammu and Kashmir, India

Bangalore, Karnataka, India

Mangalore, Karnataka, India

Ernākulam, Kerala, India

Thrissur, Kerala, India

Trivandrum, Kerala, India

Cherthala, Maharashtra, India

Mumbai, Maharashtra, India

Nagpur, Maharashtra, India

Nashik, Maharashtra, India

Pune, Maharashtra, India

Delhi, National Capital Territory of Delhi, India

Mohali, Punjab, India

Bikaner, Rajasthan, India

Fortis Escort Hospital

Jaipur, Rajasthan, India

Apollo First Med Hospitals

Chennai, Tamil Nadu, India

Life Line Multispecialty Hospital

Chennai, Tamil Nadu, India

Chennai, Tamil Nadu, India

Coimbatore, Tamil Nadu, India

Lucknow, Uttar Pradesh, India

Kolkata, West Bengal, India

Afula, , Israel

Haifa, , Israel

Holon, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Ramat Gan, , Israel

Tel Aviv, , Israel

Liepāja, , Latvia

Rēzekne, , Latvia

Valmiera, , Latvia

Ventspils, , Latvia

Beirut, , Lebanon

Arequipa, , Peru

Cuzco, , Peru

Lima, , Peru

Bydgoszcz, , Poland

Lodz, , Poland

Mielec, , Poland

Poznan, , Poland

Puławy, , Poland

Łańcut, , Poland

Engel's, , Russia

Niznhy Novgorod, , Russia

Novosibirsk, , Russia

Saint Petersburg, , Russia

Tomsk, , Russia

Belgrade, , Serbia

Kragujevac, , Serbia

Niš, , Serbia

Novi Sad, , Serbia

Trnava, , Slovakia

Middelburg, Mpumalanga, South Africa

Bloemfontein, , South Africa

Dundee, , South Africa

Durban, , South Africa

Krugersdorp, , South Africa

Limpopo, , South Africa

Port Elizabeth, , South Africa

Pretoria, , South Africa

Somerset West, , South Africa

Worcester, , South Africa

Chernivtsi, , Ukraine

Donetsk, , Ukraine

Kharkiv, , Ukraine

Kyiv, , Ukraine

Odesa, , Ukraine

Poltava, , Ukraine

Sumy, , Ukraine

Vinnytsia, , Ukraine

Leicester, , United Kingdom

Countries

United States; Argentina; Belgium; Bosnia and Herzegovina; Brazil; Bulgaria; Canada; Chile; Czechia; Germany; Hungary; India; Israel; Latvia; Lebanon; Peru; Poland; Russia; Serbia; Slovakia; South Africa; Ukraine; United Kingdom

References

de Jong MD, Ison MG, Monto AS, Metev H, Clark C, O'Neil B, Elder J, McCullough A, Collis P, Sheridan WP. Evaluation of intravenous peramivir for treatment of influenza in hospitalized patients. Clin Infect Dis. 2014 Dec 15;59(12):e172-85. doi: 10.1093/cid/ciu632. Epub 2014 Aug 12.

Reference Type: DERIVED

PMID: 25115871 (View on PubMed)

Other Identifiers

BCX1812-301

Identifier Type: -

Identifier Source: org_study_id