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

Influenza Clinical Trial

Official title:

A Phase 3, Randomized, Open Label, Active-controlled Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of IV Peramivir Compared to Oral Oseltamivir in Pediatric Subjects With Acute Uncomplicated Influenza

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369159
• Other study ID #: BCX1812-305
• Status: Completed
• Phase: Phase 3
• Start date: March 11, 2015
• Est. completion date: May 14, 2020

Study information

• Verified date: February 2021
• Source: BioCryst Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: May 14, 2020
• Est. primary completion date: October 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Peramivir

• Oseltamivir

Locations

Country	Name	City	State
South Africa	Peramivir Investigative Site	Pretoria
United States	Peramivir investigative site	Dayton	Ohio
United States	Peramivir investigative site	Draper	Utah
United States	Peramivir Investigative Site	Houston	Texas
United States	Peramivir investigative site	Salt Lake City	Utah
United States	Peramivir investigative site	San Antonio	Texas
United States	Peramivir Investigative Site	Shreveport	Louisiana
United States	Peramivir investigative site	Smithfield	Pennsylvania
United States	Peramivir investigative site	South Jordan	Utah
United States	Peramivir investigative site	Splendora	Texas

Sponsors (1)

Lead Sponsor	Collaborator
BioCryst Pharmaceuticals

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.	Safety evaluation included assessment of Adverse Events (AEs).	14 days
Secondary	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.	up to 6 hours post peramivir infusion
Secondary	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.	14 days
Secondary	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.	14 days
Secondary	Time to Reduction in Viral Shedding	Assessment of viral shedding in bilateral, mid-nasal swab specimens taken at baseline and then on Day 3, 7 and 14.	14 days
Secondary	Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.	Change in influenza viral titers was defined as the time-weighted change from Baseline in log_10 tissue culture infective dose_50 (TCID50/mL) and was summarized for each treatment group.	Change from baseline assessed on days 3, 7 and 14.
Secondary	Influenza-Related Complications Assessment.	The investigator performed a full physical exam at baseline. At each follow-up visit, study personnel evaluated the subject for the presence of clinical signs and symptoms of the following influenza-related complications: sinusitis, otitis media, bronchitis, and pneumonia requiring antibiotic use, diagnosed after initiation of treatment.	14 days