Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza
Phase II, Multicenter, Randomized, Double-Mask, Double-Dummy Study Comparing Efficacy and Safety of Intravenous Peramivir Once Daily Versus Oral Oseltamivir Twice Daily in Adults With Acute Serious or Potentially Life-Threatening Influenza
1 other identifier
interventional
137
7 countries
83
Brief Summary
This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2007
83 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
March 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 29, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
February 12, 2015
CompletedFebruary 12, 2015
January 1, 2015
1.2 years
March 27, 2007
January 16, 2015
January 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Clinical Stability (Kaplan-Meier Estimate)
Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).
14 days
Secondary Outcomes (5)
Change From Baseline in Scores of Symptoms of Influenza
Baseline, Days 2, 3, 4, 5, 10, and 14
Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate)
14 days
Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study)
14 days
Time to Hospital Discharge (Kaplan-Meier Estimate)
14 days
Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined)
Baseline, and 12, 24, 36, 48, 72, and 96 hours
Study Arms (3)
Arm 1: Peramivir 200 mg
EXPERIMENTALPeramivir 200 mg administered intravenously once daily for 5 days (5 doses)
Arm 2: Peramivir 400 mg
EXPERIMENTALPeramivir 400 mg administered intravenously once daily for 5 days (5 doses)
Arm 3: Oseltamivir
EXPERIMENTALOseltamivir 75 mg oral suspension administered orally twice daily for 5 days (10 doses)
Interventions
Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml)
Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
Eligibility Criteria
You may qualify if:
- Age ≥18 years of age, male or female
- Able to provide informed consent, or for whom consent may be provided by guardian
- Presence of fever at time of screening of ≥38.0°C (≥ 100.0°F) taken orally, or ≥38.5°C (≥101.2°F) taken rectally. This requirement is waived if the subject has (1) a history of fever within 24 hours prior to screening and administered any antipyretic(s) in the 24 hours prior to screening, or (2) has no history of documented fever as defined above, but reports a symptom of feverishness at some time during 48 hours prior to screening
- Presence of at least 1 respiratory symptom (cough, sore throat, nasal congestion/symptoms) of any severity (mild, moderate, severe)
- Presence of at least 1 constitutional symptom (headache, myalgia, feverishness, malaise, fatigue) of any severity (mild, moderate, severe)
- Onset of illness no more than 72 hours before presentation. Time of onset of illness defined as either (1) the time when temperature (oral or rectal) was elevated (at least 1°C of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least 1 respiratory symptom AND the presence of at least 1 constitutional symptom
- Presence of 1 or more of the following factors in a subject willing to be hospitalized for inpatient observation and treatment:
- Age ≥60 years
- Presence of chronic obstructive pulmonary disease (COPD) or other chronic lung disease requiring daily pharmacotherapy
- History of congestive heart failure with or without medically significant recent change in cardiac status, but without signs or symptoms compatible with NYHA Class IV functional status
- 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
- Systolic blood pressure \<90 mmHg
- Severity of illness that, in the Investigator's judgment, justifies hospitalization of the subject for supportive care
- Positive rapid antigen test (RAT) for influenza A and/or influenza B (using an approved test kit) or other test for influenza virus antigen performed in a clinical laboratory at the screening/enrollment evaluation
- +5 more criteria
You may not qualify if:
- Immunized against influenza with live attenuated virus vaccine in the previous weeks
- Treatment with any dose(s) of rimantadine, amantadine, zanamivir, or oseltamivir in the previous 7 days
- Current clinical evidence of a recognized or suspected acute non-influenzal infectious illness with onset prior to Screening
- Serum creatinine laboratory result at Screening \>1.6 mg/dL or a result \>25% above the upper limit of normal for the laboratory performing the test
- History of clinically significant proteinuria (≥1000 mg/24 hrs)
- History of moderate or severe renal impairment and/or previous clinical laboratory data indicating an estimated creatinine clearance \<50 mL/min during the previous 12 months
- Electrocardiogram (ECG) at Screening visit showing evidence of acute ischemia, or presence of a medically significant dysrhythmia
- Presence of cardiac signs or symptoms compatible with NYHA Class III or Class IV functional status for congestive heart failure or angina (see NYHA Appendix V)
- History of organ transplantation during the previous 12 months
- Known HIV infection with most recent CD4+ T-cell count ≤350 cells/mL
- History of diagnosis of any type of cancer (hematologic or solid tumor), that has required chemotherapy or radiation therapy in the previous 12 months, excluding non-melanomatous localized skin cancer
- Presence of ongoing requirement for chronic mechanical ventilation, either via oral or nasotracheal intubation or via tracheostomy, or chronic or intermittent requirement for BiPAP (bilevel positive airway pressure) at screening. Note: Subjects who require intermittent CPAP treatment for sleep apnea (without oxygen supplementation) may be enrolled
- Subjects who require acute mechanical ventilatory support of any type at the time of screening.
- History of alcohol abuse or drug addiction during the previous 12 months
- Participation in a clinical study of an experimental medication or other treatment during the previous 4 weeks
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, 36608, United States
St. Bernards Research Center/Clopton Clinic
Jonesboro, Arkansas, 72401, United States
Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.
Orange, California, 92868, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
University of California Davis Medical Center, Department of Emergency Medicine
Sacramento, California, 95817, United States
Good Samaritan Hospital
San Jose, California, 95124, United States
National Jewish Medical and Research Center, Clinical Research Unit
Denver, Colorado, 80206, United States
Orlando Regional Healthcare
Orlando, Florida, 32806, United States
James A. Haley Veterans Hospital, Department of Infectious Disease
Tampa, Florida, 33612, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Infectious Disease Specialists of Atlanta, P.C.
Decatur, Georgia, 30033, United States
St. Joseph's/Candler Health System, Inc.
Savannah, Georgia, 31405, United States
Idaho Falls Infectious Diseases, PLLC
Idaho Falls, Idaho, 83404, United States
Northwestern University
Chicago, Illinois, 60611, United States
Springfield Clinic, LLP
Springfield, Illinois, 62701, United States
Wishard Hospital/Indiana University
Indianapolis, Indiana, 46202, United States
Infectious Disease of Indiana, PSC
Indianapolis, Indiana, 46280, United States
Natchitoches Internal Medicine
Natchitoches, Louisiana, 71457, United States
Louisiana State University Health Sciences Center-Shreveport
Shreveport, Louisiana, 71103, United States
VA Maryland Health Care System
Baltimore, Maryland, 21201, United States
Franklin Square Hospital
Baltimore, Maryland, 21237, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Wayne State University School of Medicine
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
William Beaumont Hospital Troy
Troy, Michigan, 48085, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
Hackensack University Medical Center, Department of Infectious Disease
Hackensack, New Jersey, 07601, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754, United States
University of New Mexico
Albuquerque, New Mexico, 87131-0001, United States
Rochester General Hospital/University of Rochester
Rochester, New York, 14621-3001, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106-5083, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Lowcountry Infectious Diseases, P.A.
Charleston, South Carolina, 29414, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
Veterans Affairs Medical Center
Salem, Virginia, 24153, United States
Franciscan Health System
Tacoma, Washington, 98405, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449-5703, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522, United States
Prince Of Wales Hospital
Randwick, New South Wales, 2031, Australia
Westmead Hospital
Wentworthville, New South Wales, 2145, Australia
Cairns Base Hospital
Cairns, Queensland, 4870, Australia
Mater Adult Hospital
South Brisbane, Queensland, 4101, Australia
Gold Coast Hospital
Southport, Queensland, 4215, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Repatriation General Hospital
Daw Park, South Australia, 5041, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6060, Australia
Kelowna General Hospital
Kelowna, British Columbia, V1Y 3T1, Canada
Hamilton Health Sciences-McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5, Canada
St. Joseph's Healthcare Hamilton-L424
Hamilton, Ontario, L8N 4A6, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Mount Sinai Hospital / Toronto Medical Laboratories
Toronto, Ontario, M5G 1X5, Canada
Center de Sante et des Services Sociaux de Chicoutimi
Chicoutimi, Quebec, G7H 5H6, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4, Canada
Centre Hospitalier Universitaire de Quebec-Pavillon CHUL
Québec, Quebec, G1V 4G2, Canada
Centre de sante et de services sociaux Rimouski-Neigette (CSSSRN)
Rimouski, Quebec, G5L 5T1, Canada
Division of Infectious Diseases
Saskatoon, Saskatchewan, S7N 0W8, Canada
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
United Christian Hospital
Hong Kong, Hong Kong
The Prince of Wales Hospital
Shatin - New Territories, Hong Kong
Christchurch Hospital
Christchurch, New Zealand
Waikato Hospital
Hamilton, New Zealand
Tauranga Hospital
Tauranga, 3110, New Zealand
National University Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Global Clinical Trial Center
Port Elizabeth, E. Cape, 6020, South Africa
Genclin Corporation
Bloemfontein, Free State, 9301, South Africa
Benmed / Pentagon Hospital
Benoni, Gauteng, 1500, South Africa
Private Practice
Cape Town, Gauteng, 1724, South Africa
Newgate Centre
Johannesburg, Gauteng, 2001, South Africa
DJW Navorsing
Krugersdorp, Gauteng, 1739, South Africa
Medforum Hospital
Pretoria, Gauteng, 0001, South Africa
Eugene Marais Hospital
Pretoria, Gauteng, 0084, South Africa
Global Clinical Trials (GCT)
Pretoria, Gauteng, 0186, South Africa
Dr Bhorat
Soweto, Gauteng, 1818, South Africa
Sebastian, P
Durban, KZ-Natal, 4001, South Africa
Eksteen, MC
Mbombela, Mpumalanga, 1201, South Africa
Dr. L.J. van Zyl
Worcester, W Cape, 6850, South Africa
N1 City Hospital
Cape Town, WC, 7460, South Africa
Related Publications (1)
Ison MG, Hui DS, Clezy K, O'Neil BJ, Flynt A, Collis PJ, Simon TJ, Alexander WJ. A clinical trial of intravenous peramivir compared with oral oseltamivir for the treatment of seasonal influenza in hospitalized adults. Antivir Ther. 2013;18(5):651-61. doi: 10.3851/IMP2442. Epub 2012 Oct 30.
PMID: 23111657DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2007
First Posted
March 29, 2007
Study Start
July 1, 2007
Primary Completion
September 1, 2008
Study Completion
August 1, 2009
Last Updated
February 12, 2015
Results First Posted
February 12, 2015
Record last verified: 2015-01