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

NCT ID: NCT02369159

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-11
• Study Completion Date: 2020-05-14

Brief Summary

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peramivir (IV)

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.

Group Type: EXPERIMENTAL

Peramivir

Intervention Type: DRUG

Oseltamivir

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).

Group Type: ACTIVE_COMPARATOR

Oseltamivir

Intervention Type: DRUG

Interventions

Peramivir

Intervention Type: DRUG

Oseltamivir

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioCryst Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Vanchiere, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chief, Pediatric Infectious Diseases, Louisiana State University

Locations

Peramivir Investigative Site

Shreveport, Louisiana, United States

Peramivir investigative site

Dayton, Ohio, United States

Peramivir investigative site

Smithfield, Pennsylvania, United States

Peramivir Investigative Site

Houston, Texas, United States

Peramivir investigative site

San Antonio, Texas, United States

Peramivir investigative site

Splendora, Texas, United States

Peramivir investigative site

Draper, Utah, United States

Peramivir investigative site

Salt Lake City, Utah, United States

Peramivir investigative site

South Jordan, Utah, United States

Peramivir Investigative Site

Pretoria, , South Africa

Countries

United States; South Africa

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BCX1812-305

Identifier Type: -

Identifier Source: org_study_id