acute uncomplicated influenza MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Rapivab
Product Name: Peramivir
Product Code: BCX1812
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: peramivir
CAS Number: 229614-55-5
Current Sponsor code: BCX1812
Other
Sponsors
BioCryst Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant female subjects age birth to 17 years of age. 2. Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature = 100°F (37.8°C) or rectal temperature = 101.3ºF (= 38.5ºC) with at least one respiratory symptom (cough or rhinitis) OR a positive influenza rapid antigen test. Fever will either be documented at the time of screening or must be reported by the parent or care-giver if treatment with an antipyretic was given within 6 hours of the screening assessment. Note: enrollment at each site by clinical symptoms alone will be approved by the Sponsor at the beginning of each influenza season once influenza has been confirmed in the local community. The Sponsor may withdraw approval for symptomatic screening in any season based upon trends in influenza surveillance data. Prior to sponsor approval or after approval is withdrawn, criteria 2 must be met by a positive influenza RAT test. During the period of approval, clinical symptoms alone will be adequate to meet criteria 2. 3. Onset of symptoms no more than 72 hours before presentation for screening for subjects =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age > 17 years. 2. If less than 3 months of age at screening, history of premature birth ( 10 mg prednisone or equivalent on a daily basis within 30 days of screening. 10. Complicated influenza characterized by any of the following: a. ICU care b. Evidence of organ dysfunction c. Proven or suspected concomitant bacterial infection d. Other known concomitant viral infection that is likely to complicate medical course such as RSV, parainfluenza virus and adenovirus. Co-infection with rhinovirus and enterovirus is allowed. 11. Previous participation in Study BCX1812-305 or participation in a study of any investigational drug or device within the last 30 days. 12. Subjects who cannot comply with all aspects of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of intravenous (IV) peramivir compared with oral oseltamivir in pediatric subjects with acute uncomplicated influenza (here within referred to as influenza);Secondary Objective: To describe the pharmacokinetics (PK) of IV peramivir in pediatric subjects with influenza To evaluate the effectiveness of IV peramivir compared with oral oseltamivir in pediatric subjects with influenza To evaluate the incidence of influenza complications, specifically, otitis media, sinusitis, bronchitis, or pneumonia requiring antibiotic use diagnosed after initiation of study drug;Primary end point(s): Adverse Events (AEs), laboratory analyses (clinical chemistry, hematology and urinalysis), vital signs, physical examinations;Timepoint(s) of evaluation of this end point: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical: Time to resolution of fever; Time to resolution of influenza symptoms (per the age appropriate symptoms); Virologic: Viral shedding; Virus susceptibility;Timepoint(s) of evaluation of this end point: Day 14 | — |
Countries
South Africa, United States
Contacts
Public ContactMedical Monitor
BioCryst Pharmaceuticals Inc
Outcome results
None listed