|
Clinical
Research Study
Mercy St. Vincent Medical Center
|
A 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
Sponsored by: BioCryst Pharmaceuticals
Purpose
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.
| Estimated Enrollment: | 400 | | Study Start Date: | November 2009 | | Estimated Study Completion Date: | 2011 | | Estimated Pimary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: |
12 Years and older |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
Criteria
Inclusion Criteria:
Age ¡Ý12 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:
Oral temperature > 38.0 ¡ãC (>100.0 ¡ãF), 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 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 ¡Ý60 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 dialysis.
Serum creatinine > 2.0 mg/dL.
Diagnosis of Influenza by satisfying one of the following:
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
Clinical Influenza with Negative Rapid Antigen Test (RAT). Subjects with a negative RAT or other clinical laboratory 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 Scheme (EISS); 2) prior enrollment of a RAT positive subject into this study at the same institution in the current influenza season.
Females must fulfill one of the following conditions:
Subject is surgically sterile or clinically post-menopausal.
Subject has been sexually abstinent 4 weeks prior to date of screening evaluation and is willing to remain abstinent through 4 weeks after study-drug administration.
Subject has been using oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches for 3 months prior to the study, and use will continue through 4 weeks after study-drug administration.
Subject has been using an intra-uterine device, or adequate double-barrier method such as condom or diaphragm with spermicidal gel or foam as birth control 4 weeks prior to date of Screening evaluation, and use will continue through 4 weeks after study drug administration.
Males will ensure that their female partners of childbearing potential will utilize approved contraceptive methods to avoid pregnancy.
Exclusion Criteria:
Subjects who have developed clinical manifestations of influenza after having been hospitalized for a condition other than confirmed or suspected influenza.
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.
Serum bilirubin > 6 mg/dL 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.
Requirement for vasopressor support to maintain satisfactory hemodynamic status at time of screening evaluation.
Serum creatinine > 5.0 mg/dL at time of screening evaluation.
Subjects who require peritoneal dialysis or hemofiltration.
Altered neurologic status as defined by a Glasgow Coma Score of ¡Ü 9, unless medically induced.
Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or lactating.
Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy.
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 regimen (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 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 who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
Contacts
Physicians:
Luis E Jauregui, MD
Arlette Aouad, MD
Tanyanyiwa Chinyadza, MD
Nelson Nicolasora, MD
David Miramontes, MD
Lead Coordinator:
Dee Tilley, RN, CCRC
Pamela Beavers, RN, CCRC
Tina Steinhauser, BSN, CCRC
Please contact us at 419-251-4919 for more information about this study.
|
