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

BioCryst

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Drug: Oseltamivir; Drug: Peramivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02369159

BCX1812-305

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

Peramivir (IV)

Experimental group

Description:

Subjects randomized to peramivir will receive an age appropriate single dose, diluted to a maximum volume of 100 mL in normal saline, administered as a short intravenous infusion over a minimum of 15 minutes. * Subjects ≥12 years will receive a dose of 600 mg. * Subjects \<12 years will receive a dose of 12 mg/kg (to a maximum dose of 600 mg). * Subjects \< 6 months will receive a dose of 8 mg/kg.

Treatment:

Drug: Peramivir

Oseltamivir

Active Comparator group

Description:

Subjects randomized to oral oseltamivir will receive an age appropriate dose twice daily for 5 days. * Subjects ≥ 13 years will receive a 75mg dose administered as a capsule or oral suspension (twice daily for 5 days). * Subjects \< 13 years of age will receive a weight-based dose administered as a capsule or oral suspension (twice daily for 5 days).

Treatment:

Drug: Oseltamivir