None listed
Conditions
Brief summary
The primary purpose of this study is to evaluate how effective a single intra-venously administered dose of Peramivir will be at reducing the symptoms assoicated with uncomplicated Influenza. The success of the medication will be assessed through a patient diary, evaluating influenza symptoms. The Sponsor's of this study hypothesize that Peramivir as a single intra-venous injection will be effective at reducing the duration of influenza symptoms from 7 days to 5 days.
Interventions
This is a multinational, randomized, double-mask study comparing the efficacy and safety of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza. Subjects will be stratified according to their current smoking behavior and centrally randomized to receive one of three treatments:
Treatment Group 1: Peramivir 150mg
Treatment Group 2: Peramivir 300mg
All treatment arms are a single once of intra-muscular injection.
Sponsors
BioCryst Pharmaceuticals Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
2. Presence of fever at time of screening of =38.0 ºC (=100.4 ºF) taken orally, or =38.5 ºC (=101.2 ºF) taken rectally. However, this requirement is waived if the subject has a history of fever within the 24 hours prior to screening and has been administered antipyretic(s) in the 6 hours prior to screening.3. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe)4. Presence of at least one constitutional symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) of any severity (mild, moderate, or severe)5. Onset of illness no more than 48 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 ºC 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.6. Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab is positive. A negative initial RAT may be repeated within one hour of obtaining a negative result. A second negative RAT result will exclude the subject from evaluation for enrollment.7. Females of childbearing potential must report one of the following:• Be surgically sterile• 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• 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• 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.
Exclusion criteria
1. Women who are breast-feeding2. History of diagnosed chronic obstructive pulmonary disease or diagnosis of severe persistent asthma3. History of chronic renal impairment requiring hemodialysis or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min)4. History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class II, III, or IV within the past 12 months5. Immunocompromised status due to illness or previous organ transplant6. Current use of systemic immunosuppressive medications (except inhaled corticosteroids)7. Use of rimantadine, amantadine, zanamivir, or oseltamivir in the past 7 days8. Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days9. Clinical evidence of active bacterial infection at any body site requiring therapy with oral or systemic antibiotics10. Clinically significant signs of acute respiratory distress11. Clinically significant signs of acute cardiac disease12. Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia 13. Presence of a chronic disease or illness(es) with either clinical or historical evidence of recent exacerbation of such disease(s) or illness(es) or lack of control of such disease(s) or illness(es)14. History of hepatitis B, hepatitis C, or human immunodeficiency virus infection15. History of alcohol abuse or drug addiction within 1 year prior to admission in the study16. Participation in a study of any investigational drug within the last 30 days 17. Positive urine pregnancy test.
Outcome results
None listed