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

PHASE3TerminatedINTERVENTIONAL
Enrollment

405

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

November 30, 2012

Study Completion Date

October 31, 2013

Conditions
CoughSore ThroatNasal CongestionHeadacheFeverSeasonal Influenza
Interventions
DRUG

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."

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.

Trial Locations (196)

1233

Fifth MHAT-Sofia, AD, Sofia

1407

MHAT - Tokuda Hospital Sofia, AD, Sofia

1606

Military Medical Academy - MHAT, Sofia

1638

Hospital del Torax Dr. Antonio A. Cetrangolo, Buenos Aires

5000

MHAT 'Dr. St. Cherkezov', AD, Veliko Tarnovo

6000

Principal SMO Dr. Bugyi Istvan Korhaz Szentes, Szentes

7002

DDPPDI - Ruse, Rousse

8000

Fejer Megyei Szent Gyorgy Korhaz, Székesfehérvár

20010

Washington Hospital Center CAR, Washington D.C.

22908

University of Virginia Health System, Charlottesville

24014

Carilion Infectious Disease, Roanoke

24153

VA Medical Center - Salem, Salem

27599

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

30033

DeKalb Medical Center, Decatur

41701

Kentucky Lung Clinic, Hazard

43215

Remington-Davis, Inc., Columbus

43608

ID Clinical Research, LTD, Toledo

43614

Medical College Of Ohio, Toledo

45801

Regional Infection Diseases Infusion Center Inc., Lima

48073

William Beaumont Hospital, Royal Oak

48085

William Beaumont Hospital, Troy

48201

Wayne State University - Hutzel Hospital, Detroit

Wayne State University, Department of Emergency Medicine, Detroit

61265

Medical Arts Associates, Ltd., Moline

63110

Washington University School of Medicine, St Louis

80033

Drogue Medical, LLC, Wheat Ridge

91911

Sharp Chula Vista Medical Center, San Diego

92868

Pulmonary Consultants PC Physicians Medical Group, Inc., Orange

93053

Universitaetsklinikum Regensburg, Regensburg

95817

UC Davis Medical Center, Sacramento

302017

Fortis Escort Hospital, Jaipur

600010

Apollo First Med Hospitals, Chennai

600096

Life Line Multispecialty Hospital, Chennai

Unknown

La Mesa

Long Beach

Modesto

Oceanside

Orange

San Diego

Denver

Washington D.C.

Fort Lauderdale

Miami

Orlando

West Palm Beach

Columbus

Savannah

Honolulu

Springfield

South Bend

Natchitoches

New Orleans

Annapolis

Baltimore

Detroit

St Louis

Las Vegas

New Brunswick

Manhasset

New York

The Bronx

Dayton

Kettering

Toledo

Allentown

Philadelphia

East Providence

Charleston

Sioux Falls

San Antonio

Buenos Aires

Caba

Córdoba

Mendoza

Merlo

Rosario

Santa Fe

Vicente López

Brussels

Liège

Mons

Sarajevo

Tuzla

Belo Horizonte

Curitiba

Passo Fundo

Porto Alegre

Campinas

Santo André

Santos

São Paulo

Plovdiv

Sofia

MHAT - Tokuda Hospital Sofia, AD, Stara Zagora

Kelowna

Kingston

Toronto

Chicoutimi

Québec

Sherbrooke

Hospital Clinico Regional Dr. Guillermo Grant Benavente, Concepción

Santiago

Temuco

Hradec Králové

Prague

Tábor

Berlin

Cologne

Erlangen

Göttingen

Mainz

Debrecen

Fehérgyarmat

Zalaegerszeg

Hyderabad

Secunderabad

Ahmedabad

Karamsad

Surat

Vadodara

Faridabad

Srinagar

Bangalore

Mangalore

Ernākulam

Thrissur

Trivandrum

Cherthala

Mumbai

Nagpur

Nashik

Pune

Delhi

Mohali

Bikaner

Chennai

Coimbatore

Lucknow

Kolkata

Afula

Haifa

Holon

Jerusalem

Kfar Saba

Ramat Gan

Tel Aviv

Liepāja

Rēzekne

Valmiera

Ventspils

Beirut

Arequipa

Cuzco

Lima

Bydgoszcz

Lodz

Mielec

Poznan

Puławy

Łańcut

Engel's

Niznhy Novgorod

Novosibirsk

Saint Petersburg

Tomsk

Belgrade

Kragujevac

Niš

Novi Sad

Trnava

Middelburg

Bloemfontein

Dundee

Durban

Krugersdorp

Limpopo

Port Elizabeth

Pretoria

Somerset West

Worcester

Chernivtsi

Donetsk

Kharkiv

Kyiv

Odesa

Poltava

Sumy

Vinnytsia

Leicester

32790-2706

Florida Hospital, Winter Park

02215

Beth Israel Deaconess Medical Center, Boston

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

L8N 4A6

St. Joseph's Healthcare Hamilton, Hamilton

56 2 5681332

Hosp. de Urgencia Asistencia Publica Dr. Alejandro del Rio, Santiago

625 00

Fakultni nemocnice Brno, Brno

401 13

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

Sponsors
All Listed Sponsors
collaborator

Department of Health and Human Services

FED

lead

BioCryst Pharmaceuticals

INDUSTRY