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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

Information source: BioCryst Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cough; Sore Throat; Nasal Congestion; Headache; Fever; Seasonal Influenza

Intervention: Peramivir+SOC (Drug); Placebo+SOC (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: BioCryst Pharmaceuticals

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time to Clinical Resolution (Kaplan-Meier Estimate)

Secondary outcome:

Change (Reduction) in Influenza Virus Titer

Time to Alleviation of Clinical Symptoms of Influenza

Time to Resolution of Fever (Kaplan-Meier Estimate)

Time to Resumption of Usual Activities

Number of Subjects With ICU Admission

Duration of All ICU Admissions (Kaplan-Meier Estimate)

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Buenos Aires, Argentina

Hospital del Torax Dr. Antonio A. Cetrangolo, Buenos Aires 1638, Argentina

Caba, Argentina

Cordoba, Argentina

Mendoza, Argentina

Merlo, Argentina

Rosario, Argentina

Santa Fe, Argentina

Vicente Lopez, Argentina

Bruxelles, Belgium

Liege, Belgium

Mons, Belgium

Sarajevo, Bosnia and Herzegovina

Tuzla, Bosnia and Herzegovina

Plovdiv, Bulgaria

DDPPDI - Ruse, Ruse 7002, Bulgaria

Sofia, Bulgaria

Fifth MHAT-Sofia, AD, Sofia 1233, Bulgaria

MHAT - Tokuda Hospital Sofia, AD, Sofia 1407, Bulgaria

Military Medical Academy - MHAT, Sofia 1606, Bulgaria

MHAT - Tokuda Hospital Sofia, AD, Stara Zagora, Bulgaria

MHAT 'Dr. St. Cherkezov', AD, Veliko Tarnovo 5000, Bulgaria

Quebec, Canada

Hospital Clinico Regional Dr. Guillermo Grant Benavente, Concepcion, Chile

Santiago, Chile

Hosp. de Urgencia Asistencia Publica Dr. Alejandro del Rio, Santiago 56 2 5681332, Chile

Temuco, Chile

Fakultni nemocnice Brno, Brno 625 00, Czech Republic

Hradec Kralove, Czech Republic

Praha, Czech Republic

Tabor, Czech Republic

Krajska zdravotni, a.s. - Masarykova nemocnice v Ustinad La, Usti nad Labem 401 13, Czech Republic

Berlin, Germany

Erlangen, Germany

Goettingen, Germany

Koeln, Germany

Mainz, Germany

Universitaetsklinikum Regensburg, Regensburg 93053, Germany

Debrecen, Hungary

Fehergyarmat, Hungary

Fejer Megyei Szent Gyorgy Korhaz, Szekesfehervar 8000, Hungary

Principal SMO Dr. Bugyi Istvan Korhaz Szentes, Szentes 6000, Hungary

Zalaegerszeg, Hungary

Delhi, India

Afula, Israel

Haifa, Israel

Holon, Israel

Jerusalem, Israel

Kfar Saba, Israel

Ramat Gan, Israel

Tel Aviv, Israel

Liepaja, Latvia

Rezekne, Latvia

Valmiera, Latvia

Ventspils, Latvia

Beirut, Lebanon

Arequipa, Peru

Cuzco, Peru

Lima, Peru

Bydgoszcz, Poland

Lancut, Poland

Lodz, Poland

Mielec, Poland

Poznan, Poland

Pulawy, Poland

Engels, Russian Federation

Niznhy Novgorod, Russian Federation

Novosibirsk, Russian Federation

St. Petersburg, Russian Federation

Tomsk, Russian Federation

Belgrade, Serbia

Kragujevac, Serbia

Nis, Serbia

Novi Sad, Serbia

Trnava, Slovakia

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

Chernivci, Ukraine

Donetsk, Ukraine

Kharkiv, Ukraine

Kyiv, Ukraine

Odesa, Ukraine

Poltava, Ukraine

Sumy, Ukraine

Vinnytsya, Ukraine

Leicester, United Kingdom

Hyderabad, Andhra Pradesh, India

Secunderabad, Andhra Pradesh, India

Kelowna, British Columbia, Canada

La Mesa, California, United States

Long Beach, California, United States

Modesto, California, United States

Oceanside, California, United States

Orange, California, United States

Pulmonary Consultants PC Physicians Medical Group, Inc., Orange, California 92868, United States

UC Davis Medical Center, Sacramento, California 95817, United States

San Diego, California, United States

Sharp Chula Vista Medical Center, San Diego, California 91911, United States

Denver, Colorado, United States

Drogue Medical, LLC, Wheat Ridge, Colorado 80033, United States

Washington, District of Columbia, United States

Washington Hospital Center CAR, Washington, District of Columbia 20010, United States

Ft. Lauderdale, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

West Palm Beach, Florida, United States

Florida Hospital, Winter Park, Florida 32790-2706, United States

Columbus, Georgia, United States

DeKalb Medical Center, Decatur, Georgia 30033, United States

Savannah, Georgia, United States

Ahmedabad, Gujarat, India

Karamsad, Gujarat, India

Surat, Gujarat, India

Vadodara, Gujarat, India

Faridabad, Haryana, India

Honolulu, Hawaii, United States

Medical Arts Associates, Ltd., Moline, Illinois 61265, United States

Springfield, Illinois, United States

South Bend, Indiana, United States

Srinagar, Jammu & Kashmir, India

Bangalore, Karnataka, India

Mangalore, Karnataka, India

Kentucky Lung Clinic, Hazard, Kentucky 41701, United States

Ernakulam, Kerala, India

Thrissur, Kerala, India

Trivandrum, Kerala, India

Natchitoches, Louisiana, United States

New Orleans, Louisiana, United States

Belo Horizonte, MG, Brazil

Cherthala, Maharashtra, India

Mumbai, Maharashtra, India

Nagpur, Maharashtra, India

Nashik, Maharashtra, India

Pune, Maharashtra, India

Annapolis, Maryland, United States

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Detroit, Michigan, United States

Wayne State University - Hutzel Hospital, Detroit, Michigan 48201, United States

Wayne State University, Department of Emergency Medicine, Detroit, Michigan 48201, United States

William Beaumont Hospital, Royal Oak, Michigan 48073, United States

William Beaumont Hospital, Troy, Michigan 48085, United States

St. Louis, Missouri, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Middelburg, Mpumalanga, South Africa

Las Vegas, Nevada, United States

New Brunswick, New Jersey, United States

Bronx, New York, United States

Manhasset, New York, United States

New York, New York, United States

University of North Carolina at Chapel Hill AIDS Clinical Trials Unit, Chapel Hill, North Carolina 27599, United States

Remington-Davis, Inc., Columbus, Ohio 43215, United States

Dayton, Ohio, United States

Kettering, Ohio, United States

Regional Infection Diseases Infusion Center Inc., Lima, Ohio 45801, United States

Toledo, Ohio, United States

ID Clinical Research, LTD, Toledo, Ohio 43608, United States

Medical College Of Ohio, Toledo, Ohio 43614, United States

St. Joseph's Healthcare Hamilton, Hamilton, Ontario L8N 4A6, Canada

Kingston, Ontario, Canada

Toronto, Ontario, Canada

Curitiba, PR, Brazil

Allentown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Mohali, Punjab, India

Chicoutimi, Quebec, Canada

Sherbrooke, Quebec, Canada

Passo Fundo, RS, Brazil

Porto Alegre, RS, Brazil

Hospital de Clinicas de Porto Alegre, Porto Alegre, RS 90035-903, Brazil

Bikaner, Rajasthan, India

Fortis Escort Hospital, Jaipur, Rajasthan 302017, India

East Providence, Rhode Island, United States

Campinas, SP, Brazil

Santo Andre, SP, Brazil

Santos, SP, Brazil

Sao Paulo, SP, Brazil

Charleston, South Carolina, United States

Sioux Falls, South Dakota, United States

Chennai, Tamil Nadu, India

Apollo First Med Hospitals, Chennai, Tamil Nadu 600010, India

Life Line Multispecialty Hospital, Chennai, Tamil Nadu 600096, India

Coimbatore, Tamil Nadu, India

San Antonio, Texas, United States

Lucknow, Uttar Pradesh, India

University of Virginia Health System, Charlottesville, Virginia 22908, United States

Carilion Infectious Disease, Roanoke, Virginia 24014, United States

VA Medical Center - Salem, Salem, Virginia 24153, United States

Kolkata, West Bengal, India

Additional Information

Starting date: November 2009
Last updated: January 28, 2015

Page last updated: August 23, 2015

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