To evaluate the effects on time to clinical stability associated with treatment with peramivir administered intravenously compared to oral oseltamivir in adults hospitalized with acute serious or potentially life-threatening influenza
- Conditions
- InfluenzaLife threatening comorbidities suchs as COPD, congestive heart failure and diabetes.Respiratory - Other respiratory disorders / diseasesRespiratory - Chronic obstructive pulmonary diseaseMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12607000282482
- Lead Sponsor
- BioCryst Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 120
Able to provide informed consent, or for whom consent may be provided by guardian 3. Presence of fever at time of screening of =38.0 °C (100.4 °F) taken orally, or =38.5 °C (101.2 °F) taken rectally. Note: subject may be enrolled with temperature less than that stated above if there is a history of fever in the past 24-hours and the subject has administered any antipyretic medication(s) in the 6 hours prior to screening4. Presence of at least one respiratory symptom (cough, sore throat, or nasal congestion/symptoms) of any severity (mild, moderate, or severe)5. Presence of at least one constitutional symptom (headache, myalgia, feverishness, malaise, or fatigue) of any severity (mild, moderate, or severe)6. 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 (either oral or rectal) was first measured as elevated (at least one degree (°C) of elevation-oral temperature), 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 7. Presence of one or more of the following factors in a subject who is 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 care8. Positive rapid antigen test (RAT) for influenza A and/or influenza B (using an approved test kit) at the screening/enrollment evaluation9. 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
1. Immunized against influenza with live attenuated virus vaccine in the previous 3 weeks2. Treatment with any dose(s) of rimantadine, amantadine, zanamivir, or oseltamivir in the previous 7 days3. Serum creatinine laboratory result at screening of > 1.6 mg/dL or a result that is > 25% above the upper limit of normal for the laboratory performing the test4. Historical evidence of clinically significant proteinuria or documented 24-hour protein excretion of >1.0 Gm, and/or previous clinical laboratory data indicating an estimated creatinine clearance <50 mL/min during the previous 12 months5. Electrocardiogram (ECG) at screening visit showing evidence of acute ischemia, or presence of a medically significant dysrhythmia6. Presence of cardiac signs or symptoms compatible with NYHA Class IV functional status7. Presence of diagnosed COPD or other chronic lung condition requiring continuous or intermittent oxygen therapy as an outpatient 8. History of organ transplantation during the previous 12 months9. HIV infection with most recent CD4 cell count =350 cells/mL10. History of gastrointestinal bleeding or gastrointestinal surgery during the previous 12 months11. 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 cancer12. 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 are determined to require acute supplemental oxygen therapy at time of screening and/or at hospital admission may be enrolled13. History of alcohol abuse or drug addiction during the previous 12 months14. Participation in a clinical study of an experimental medication or other treatment during the previous 4 weeks15. Previous treatment with peramivir in any dose or formulation16. Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method