Influenza Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 137 |
Est. completion date | August 2009 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - Females of childbearing potential must report one of the following: - Be surgically sterile or clinically post-menopausal - Have been sexually abstinent 4 weeks prior to date of screening evaluation and be willing to remain abstinent through 4 weeks after study-drug administration for all perimenopausal women or women of child-bearing potential - Use oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches and have been using these for 3 months prior through 4 weeks after study-drug administration for all perimenopausal women or women of child-bearing potential - Use an intra-uterine device (IUD), or adequate barrier contraception (or double-barrier method such as condom or diaphragm with spermicidal gel or foam) as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration for all perimenopausal women or women of child-bearing potential Exclusion Criteria: - 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) - Presence of diagnosed COPD or other chronic lung condition requiring either continuous or intermittent oxygen therapy as an outpatient. Note: Subjects who are determined to require acute supplemental oxygen therapy at the time of Screening and/or at hospital admission may be enrolled, if exclusion criteria #13 or #14 are not applicable. - 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 - Previous treatment with intravenous or intramuscular peramivir - Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding - Subjects who have been hospitalized due to a condition other than acute influenza and in whom influenza is diagnosed during hospitalization. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Cairns Base Hospital | Cairns | Queensland |
Australia | Repatriation General Hospital | Daw Park | South Australia |
Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
Australia | Royal Melbourne Hospital | Parkville | Victoria |
Australia | Prince Of Wales Hospital | Randwick | New South Wales |
Australia | Mater Adult Hospital | South Brisbane | Queensland |
Australia | Gold Coast Hospital | Southport | Queensland |
Australia | Westmead Hospital | Wentworthville | New South Wales |
Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
Canada | Center de Sante et des Services Sociaux de Chicoutimi | Chicoutimi | Quebec |
Canada | Hamilton Health Sciences-McMaster University Medical Centre | Hamilton | Ontario |
Canada | St. Joseph's Healthcare Hamilton-L424 | Hamilton | Ontario |
Canada | Kelowna General Hospital | Kelowna | British Columbia |
Canada | Maisonneuve-Rosemont Hospital | Montreal | Quebec |
Canada | The Ottawa Hospital - General Campus | Ottawa | Ontario |
Canada | Centre Hospitalier Universitaire de Quebec-Pavillon CHUL | Quebec | |
Canada | Centre de sante et de services sociaux Rimouski-Neigette (CSSSRN) | Rimouski | Quebec |
Canada | Division of Infectious Diseases | Saskatoon | Saskatchewan |
Canada | Mount Sinai Hospital / Toronto Medical Laboratories | Toronto | Ontario |
Hong Kong | 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 | |
New Zealand | Christchurch Hospital | Christchurch | |
New Zealand | Waikato Hospital | Hamilton | |
New Zealand | Tauranga Hospital | Tauranga | |
Singapore | National University Hospital | Singapore | |
Singapore | Tan Tock Seng Hospital | Singapore | |
South Africa | Benmed / Pentagon Hospital | Benoni | Gauteng |
South Africa | Genclin Corporation | Bloemfontein | Free State |
South Africa | N1 City Hospital | Cape town | WC |
South Africa | Private Practice | Cape Town | Gauteng |
South Africa | Sebastian, P | Durban | KZ-Natal |
South Africa | Newgate Centre | Johannesburg, | Gauteng |
South Africa | DJW Navorsing | Krugersdorp | Gauteng |
South Africa | Eksteen, MC | Nelspruit | Mpumalanga |
South Africa | Global Clinical Trial Center | Port Elizabeth | E. Cape |
South Africa | Eugene Marais Hospital | Pretoria | Gauteng |
South Africa | Global Clinical Trials (GCT) | Pretoria | Gauteng |
South Africa | Medforum Hospital | Pretoria | Gauteng |
South Africa | Dr Bhorat | Soweto | Gauteng |
South Africa | Dr. L.J. van Zyl | Worcester | W Cape |
United States | University of New Mexico | Albuquerque | New Mexico |
United States | Medical College of Georgia | Augusta | Georgia |
United States | Franklin Square Hospital | Baltimore | Maryland |
United States | VA Maryland Health Care System | Baltimore | Maryland |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Mercury Street Medical Group, PLLC | Butte | Montana |
United States | Lowcountry Infectious Diseases, P.A. | Charleston | South Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | University Hospitals Case Medical Center | Cleveland | Ohio |
United States | Infectious Disease Specialists of Atlanta, P.C. | Decatur | Georgia |
United States | National Jewish Medical and Research Center, Clinical Research Unit | Denver | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Wayne State University School of Medicine | Detroit | Michigan |
United States | Hackensack University Medical Center, Department of Infectious Disease | Hackensack | New Jersey |
United States | Baylor College of Medicine | Houston | Texas |
United States | Idaho Falls Infectious Diseases, PLLC | Idaho Falls | Idaho |
United States | Infectious Disease of Indiana, PSC | Indianapolis | Indiana |
United States | Wishard Hospital/Indiana University | Indianapolis | Indiana |
United States | St. Bernards Research Center/Clopton Clinic | Jonesboro | Arkansas |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Pulmonary Associates of Mobile, P.C. | Mobile | Alabama |
United States | Natchitoches Internal Medicine | Natchitoches | Louisiana |
United States | Jersey Shore University Medical Center | Neptune | New Jersey |
United States | Pulmonary Consultants & Primary Care Physicians Medical Group, Inc. | Orange | California |
United States | University of California Irvine Medical Center | Orange | California |
United States | Orlando Regional Healthcare | Orlando | Florida |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
United States | Rochester General Hospital/University of Rochester | Rochester | New York |
United States | University of Rochester Medical Center | Rochester | New York |
United States | University of California Davis Medical Center, Department of Emergency Medicine | Sacramento | California |
United States | Veterans Affairs Medical Center | Salem | Virginia |
United States | University of Utah Health Sciences Center | Salt Lake City | Utah |
United States | Good Samaritan Hospital | San Jose | California |
United States | St. Joseph's/Candler Health System, Inc. | Savannah | Georgia |
United States | Louisiana State University Health Sciences Center-Shreveport | Shreveport | Louisiana |
United States | Springfield Clinic, LLP | Springfield | Illinois |
United States | Washington University School of Medicine | St. Louis | Missouri |
United States | Franciscan Health System | Tacoma | Washington |
United States | James A. Haley Veterans Hospital, Department of Infectious Disease | Tampa | Florida |
United States | William Beaumont Hospital Troy | Troy | Michigan |
Lead Sponsor | Collaborator |
---|---|
BioCryst Pharmaceuticals |
United States, Australia, Canada, Hong Kong, New Zealand, Singapore, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Change From Baseline in Scores of Symptoms of Influenza | Descriptive statistics for the change from baseline in each of the 7 symptoms of influenza (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue, each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]) were tabulated by treatment group. Missing data were excluded. | Baseline, Days 2, 3, 4, 5, 10, and 14 | No |
Secondary | Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate) | Changes in each subject's ability to perform usual activities as determined from the visual analog scale (0 to 10, where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully) were summarized by study visit and treatment group. The time to resumption of a subject's ability to perform usual activities was estimated using the method of Kaplan Meier. Subjects who did not return to the pre-study level of performance of usual activities were censored at the time of their last assessment. (Note: N is the number of ITTI participants with available data). | 14 days | No |
Secondary | Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study) | The number of subjects with clinical relapse, defined as changes in 2 or more signs of clinical stability to values outside the range of normalization criteria for a duration of at least 12 consecutive hours after clinical stability had been attained, were summarized by treatment group. | 14 days | No |
Secondary | Time to Hospital Discharge (Kaplan-Meier Estimate) | Time to discharge from hospital was estimated using the method of Kaplan Meier. Subjects who were not discharged from the hospital were censored at the time of their last assessment. | 14 days | No |
Secondary | Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined) | Reduction in viral shedding, assessed as the change in quantitative viral titers and defined as the time-weighted change from baseline in TCID50/mL, was summarized for each treatment group. | Baseline, and 12, 24, 36, 48, 72, and 96 hours | No |
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