Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza

BioCryst Pharmaceuticals137 enrolled

Overview

This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated influenza.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

137

Conditions

Influenza

Interventions

PeramivirDRUG

OseltamivirDRUG

Eligibility

Sex: ALLMin age: 0 DaysMax age: 17 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. 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 Positive influenza determined by PCR or Rapid Antigen Test 2. Onset of symptoms no more than 72 hours before presentation for screening for subjects \< 2 years old. Key Exclusion Criteria: 1. Pregnant or breast-feeding females 2. Development of symptoms while hospitalized 3. Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications 4. Presence of immunocompromised status

Locations (10)

Peramivir Investigative Site

Shreveport, Louisiana, United States

Peramivir investigative site

Dayton, Ohio, United States

Peramivir investigative site

Smithfield, Pennsylvania, United States

Outcomes

Primary Outcomes

Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.

Safety evaluation included assessment of Adverse Events (AEs).

Time frame: 14 days

Secondary Outcomes

Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose

Up to 4 blood samples will be drawn, where possible: immediately following infusion and 30 to 60 mins, 1 to 3 hrs and 4 to 6 hrs post-infusions. AUC calculations were performed in Phoenix WinNonlin using the linear/log trapezoidal rule. AUC0-last was calculated between start of the infusion and the time of the last measurable concentration.

Time frame: up to 6 hours post peramivir infusion

Time to Resolution of Fever

Time for fever resolution based on subject diary record of temperature recorded twice daily. A subject had resolution of fever if he/she had oral temperature of \< 99.4°F or an axillary temperature of \< 98.4°F and no antipyretic medications were taken for ≥ 12 hours. The time to resolution of fever was estimated for each age group and overall using the Kaplan-Meier method with temperature and symptom relief medication information obtained from the Subject Diary data.

Time frame: 14 days

Time to Resolution of Influenza Symptoms

Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a 4-point severity scale (0,absent; 1, mild; 2, moderate; 3, severe) twice daily beginning before screening on Day 1 until symptoms resolved or until the last follow-up visit. Time to alleviation of symptoms was the number of hours from initiation of study drug until the start of the time period in which all age-appropriate symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 - 10%) hours. Subjects who did not experience alleviation of symptoms were censored at the last observed symptom assessment.

Time frame: 14 days

Data from ClinicalTrials.gov

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