Uncomplicated acute influenza
Conditions
Interventions
Product Name: Peramivir
Product Code: BCX-1812
Pharmaceutical Form: Solution for injection
Current Sponsor code: BCX-1812
Other descriptive name: Peramivir
Concentration unit: mg/ml milligram(s)/milli
Sponsors
BioCryst Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant female subjects age =18 years 2. A Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab. A negative initial RAT may be repeated within one hour of obtaining a negative result. 3. 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. For subjects with a positive RAT at the time of screening, a subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at time of screening. For subjects with no positive RAT at screening, fever as defined above must be documented at time of screening 4. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe) 5. Presence of at least one constitutional symptom (myalgia [muscle aches], headache, feverishness, or fatigue) of any severity (mild, moderate, or severe) 6. Onset of symptoms no more than 48 hours before presentation for screening 7. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breast-feeding 2. Presence of clinically significant signs of acute respiratory distress 3. History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma 4. History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class IV functional status within the past 12 months 5. History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min) 6. Current clinical evidence of active bacterial infection at any body site that requires therapy with oral or systemic antibiotics 7. Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy 8. Current treatment for active viral hepatitis C 9. Presence of known HIV infection with a CD4 count <350 cell/mm3 10. Current therapy with oral warfarin or other systemic anticoagulant 11. Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening 12. Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days 13. History of alcohol abuse or drug addiction within 1 year prior to admission in the study 14. Participation in a previous study of peramivir as treatment for acute influenza or previous participation in this study 15. Participation in a study of any investigational drug within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of peramivir administered intramuscularly compared to placebo on the time to alleviation of clinical symptoms in adult subjects with uncomplicated acute influenza.;Secondary Objective: To evaluate the safety and tolerability of peramivir administered intramuscularly; To evaluate secondary clinical outcomes in response to treatment; To evaluate changes in influenza virus titer (viral shedding) in response to treatment; To assess pharmacoeconomic measures in response to treatment; To assess changes in influenza viral susceptibility to neuraminidase inhibitors following treatment ;Primary end point(s): Clinical: Time to alleviation of clinical symptoms of influenza | — |
Countries
Estonia, Finland, France, Hungary, Latvia, Spain, Sweden, United Kingdom
Outcome results
None listed