Study Stopped
This study was terminated for futility
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
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
1 other identifier
interventional
405
23 countries
196
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2009
Typical duration for phase_3
196 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
February 12, 2015
CompletedFebruary 12, 2015
January 1, 2015
3 years
August 12, 2009
January 16, 2015
January 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Clinical Resolution (Kaplan-Meier Estimate)
Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).
10 days
Secondary Outcomes (6)
Change (Reduction) in Influenza Virus Titer
Baseline and 24, 48, 108 hours
Time to Alleviation of Clinical Symptoms of Influenza
10 days
Time to Resolution of Fever (Kaplan-Meier Estimate)
10 days
Time to Resumption of Usual Activities
10 days
Number of Subjects With ICU Admission
10 days
- +1 more secondary outcomes
Other Outcomes (6)
Time to Hospital Discharge
10 days
Incidence of Influenza-Related Complications
10 days
Number of Subjects Requiring More Than 5 Days of Study Drug
10 days
- +3 more other outcomes
Study Arms (2)
Peramivir+SOC
EXPERIMENTAL* 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 COMPARATORPlacebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Interventions
* 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 Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
Eligibility Criteria
You may qualify if:
- 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:
- Oral temperature ≥ 38.0 °C (≥100.4 °F), ≥38.6°C (≥101.4 °F) tympanic or rectal OR
- Oxygen saturation \<92%, OR
- 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.
- 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).
- +4 more criteria
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioCryst Pharmaceuticalslead
- Department of Health and Human Servicescollaborator
Study Sites (196)
Unknown Facility
La Mesa, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Modesto, California, United States
Unknown Facility
Oceanside, California, United States
Pulmonary Consultants PC Physicians Medical Group, Inc.
Orange, California, 92868, United States
Unknown Facility
Orange, California, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Sharp Chula Vista Medical Center
San Diego, California, 91911, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Denver, Colorado, United States
Drogue Medical, LLC
Wheat Ridge, Colorado, 80033, United States
Washington Hospital Center CAR
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Florida Hospital
Winter Park, Florida, 32790-2706, United States
Unknown Facility
Columbus, Georgia, United States
DeKalb Medical Center
Decatur, Georgia, 30033, United States
Unknown Facility
Savannah, Georgia, United States
Unknown Facility
Honolulu, Hawaii, United States
Medical Arts Associates, Ltd.
Moline, Illinois, 61265, United States
Unknown Facility
Springfield, Illinois, United States
Unknown Facility
South Bend, Indiana, United States
Kentucky Lung Clinic
Hazard, Kentucky, 41701, United States
Unknown Facility
Natchitoches, Louisiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Annapolis, Maryland, United States
Unknown Facility
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Wayne State University - Hutzel Hospital
Detroit, Michigan, 48201, United States
Wayne State University, Department of Emergency Medicine
Detroit, Michigan, 48201, United States
Unknown Facility
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
William Beaumont Hospital
Troy, Michigan, 48085, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
New Brunswick, New Jersey, United States
Unknown Facility
Manhasset, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
The Bronx, 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
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Kettering, Ohio, United States
Regional Infection Diseases Infusion Center Inc.
Lima, Ohio, 45801, United States
ID Clinical Research, LTD
Toledo, Ohio, 43608, United States
Medical College Of Ohio
Toledo, Ohio, 43614, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Allentown, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
East Providence, Rhode Island, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Sioux Falls, South Dakota, United States
Unknown Facility
San Antonio, Texas, United States
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
Hospital del Torax Dr. Antonio A. Cetrangolo
Buenos Aires, 1638, Argentina
Unknown Facility
Buenos Aires, Argentina
Unknown Facility
Caba, Argentina
Unknown Facility
Córdoba, Argentina
Unknown Facility
Mendoza, Argentina
Unknown Facility
Merlo, Argentina
Unknown Facility
Rosario, Argentina
Unknown Facility
Santa Fe, Argentina
Unknown Facility
Vicente López, Argentina
Unknown Facility
Brussels, Belgium
Unknown Facility
Liège, Belgium
Unknown Facility
Mons, Belgium
Unknown Facility
Sarajevo, Bosnia and Herzegovina
Unknown Facility
Tuzla, Bosnia and Herzegovina
Unknown Facility
Belo Horizonte, Minas Gerais, Brazil
Unknown Facility
Curitiba, Paraná, Brazil
Unknown Facility
Passo Fundo, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, Brazil
Unknown Facility
Campinas, São Paulo, Brazil
Unknown Facility
Santo André, São Paulo, Brazil
Unknown Facility
Santos, São Paulo, Brazil
Unknown Facility
São Paulo, São Paulo, Brazil
Unknown Facility
Plovdiv, Bulgaria
DDPPDI - Ruse
Rousse, 7002, Bulgaria
Fifth MHAT-Sofia, AD
Sofia, 1233, Bulgaria
MHAT - Tokuda Hospital Sofia, AD
Sofia, 1407, Bulgaria
Military Medical Academy - MHAT
Sofia, 1606, Bulgaria
Unknown Facility
Sofia, Bulgaria
MHAT - Tokuda Hospital Sofia, AD
Stara Zagora, Bulgaria
MHAT 'Dr. St. Cherkezov', AD
Veliko Tarnovo, 5000, Bulgaria
Unknown Facility
Kelowna, British Columbia, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Unknown Facility
Kingston, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Chicoutimi, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
Hospital Clinico Regional Dr. Guillermo Grant Benavente
Concepción, Chile
Hosp. de Urgencia Asistencia Publica Dr. Alejandro del Rio
Santiago, 56 2 5681332, Chile
Unknown Facility
Santiago, Chile
Unknown Facility
Temuco, Chile
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Unknown Facility
Hradec Králové, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Tábor, Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Ustinad La
Ústí nad Labem, 401 13, Czechia
Unknown Facility
Berlin, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
Erlangen, Germany
Unknown Facility
Göttingen, Germany
Unknown Facility
Mainz, Germany
Universitaetsklinikum Regensburg
Regensburg, 93053, Germany
Unknown Facility
Debrecen, Hungary
Unknown Facility
Fehérgyarmat, Hungary
Principal SMO Dr. Bugyi Istvan Korhaz Szentes
Szentes, 6000, Hungary
Fejer Megyei Szent Gyorgy Korhaz
Székesfehérvár, 8000, Hungary
Unknown Facility
Zalaegerszeg, Hungary
Unknown Facility
Hyderabad, Andhra Pradesh, India
Unknown Facility
Secunderabad, Andhra Pradesh, India
Unknown Facility
Ahmedabad, Gujarat, India
Unknown Facility
Karamsad, Gujarat, India
Unknown Facility
Surat, Gujarat, India
Unknown Facility
Vadodara, Gujarat, India
Unknown Facility
Faridabad, Haryana, India
Unknown Facility
Srinagar, Jammu and Kashmir, India
Unknown Facility
Bangalore, Karnataka, India
Unknown Facility
Mangalore, Karnataka, India
Unknown Facility
Ernākulam, Kerala, India
Unknown Facility
Thrissur, Kerala, India
Unknown Facility
Trivandrum, Kerala, India
Unknown Facility
Cherthala, Maharashtra, India
Unknown Facility
Mumbai, Maharashtra, India
Unknown Facility
Nagpur, Maharashtra, India
Unknown Facility
Nashik, Maharashtra, India
Unknown Facility
Pune, Maharashtra, India
Unknown Facility
Delhi, National Capital Territory of Delhi, India
Unknown Facility
Mohali, Punjab, India
Unknown Facility
Bikaner, Rajasthan, India
Fortis Escort Hospital
Jaipur, Rajasthan, 302017, India
Apollo First Med Hospitals
Chennai, Tamil Nadu, 600010, India
Life Line Multispecialty Hospital
Chennai, Tamil Nadu, 600096, India
Unknown Facility
Chennai, Tamil Nadu, India
Unknown Facility
Coimbatore, Tamil Nadu, India
Unknown Facility
Lucknow, Uttar Pradesh, India
Unknown Facility
Kolkata, West Bengal, India
Unknown Facility
Afula, Israel
Unknown Facility
Haifa, Israel
Unknown Facility
Holon, Israel
Unknown Facility
Jerusalem, Israel
Unknown Facility
Kfar Saba, Israel
Unknown Facility
Ramat Gan, Israel
Unknown Facility
Tel Aviv, Israel
Unknown Facility
Liepāja, Latvia
Unknown Facility
Rēzekne, Latvia
Unknown Facility
Valmiera, Latvia
Unknown Facility
Ventspils, Latvia
Unknown Facility
Beirut, Lebanon
Unknown Facility
Arequipa, Peru
Unknown Facility
Cuzco, Peru
Unknown Facility
Lima, Peru
Unknown Facility
Bydgoszcz, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Mielec, Poland
Unknown Facility
Poznan, Poland
Unknown Facility
Puławy, Poland
Unknown Facility
Łańcut, Poland
Unknown Facility
Engel's, Russia
Unknown Facility
Niznhy Novgorod, Russia
Unknown Facility
Novosibirsk, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Tomsk, Russia
Unknown Facility
Belgrade, Serbia
Unknown Facility
Kragujevac, Serbia
Unknown Facility
Niš, Serbia
Unknown Facility
Novi Sad, Serbia
Unknown Facility
Trnava, Slovakia
Unknown Facility
Middelburg, Mpumalanga, South Africa
Unknown Facility
Bloemfontein, South Africa
Unknown Facility
Dundee, South Africa
Unknown Facility
Durban, South Africa
Unknown Facility
Krugersdorp, South Africa
Unknown Facility
Limpopo, South Africa
Unknown Facility
Port Elizabeth, South Africa
Unknown Facility
Pretoria, South Africa
Unknown Facility
Somerset West, South Africa
Unknown Facility
Worcester, South Africa
Unknown Facility
Chernivtsi, Ukraine
Unknown Facility
Donetsk, Ukraine
Unknown Facility
Kharkiv, Ukraine
Unknown Facility
Kyiv, Ukraine
Unknown Facility
Odesa, Ukraine
Unknown Facility
Poltava, Ukraine
Unknown Facility
Sumy, Ukraine
Unknown Facility
Vinnytsia, Ukraine
Unknown Facility
Leicester, United Kingdom
Related Publications (1)
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.
PMID: 25115871DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Interim analysis of the primary efficacy endpoint (time to clinical resolution) performed after the end of the 2012 Southern Hemisphere influenza season lead to study termination for futility. Final enrollment was \~70% of the planned enrollment.
Results Point of Contact
- Title
- William P. Sheridan, MBBS
- Organization
- BioCryst Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2009
First Posted
August 13, 2009
Study Start
November 1, 2009
Primary Completion
November 1, 2012
Study Completion
October 1, 2013
Last Updated
February 12, 2015
Results First Posted
February 12, 2015
Record last verified: 2015-01