Clinical trial NCT02369159: Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-02-23
Enrollment: 137
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
timeFrame: 14 days
Secondary outcomes:
measure: Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose
timeFrame: up to 6 hours post peramivir infusion
measure: Time to Resolution of Fever
timeFrame: 14 days
measure: Time to Resolution of Influenza Symptoms
timeFrame: 14 days
measure: Time to Reduction in Viral Shedding
timeFrame: 14 days
measure: Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
timeFrame: Change from baseline assessed on days 3, 7 and 14.
measure: Influenza-Related Complications Assessment.
timeFrame: 14 days
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Peramivir Investigative Site
state: Louisiana
city: Dayton
country: United States
facility: Peramivir investigative site
state: Ohio
city: Smithfield
country: United States
facility: Peramivir investigative site
state: Pennsylvania
city: Houston
country: United States
facility: Peramivir Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Peramivir investigative site
state: Texas
city: Splendora
country: United States
facility: Peramivir investigative site
state: Texas
city: Draper
country: United States
facility: Peramivir investigative site
state: Utah
city: Salt Lake City
country: United States
facility: Peramivir investigative site
state: Utah
city: South Jordan
country: United States
facility: Peramivir investigative site
state: Utah
city: Pretoria
country: South Africa
facility: Peramivir Investigative Site
Study officials:
affiliation: Chief, Pediatric Infectious Diseases, Louisiana State University
name: John Vanchiere, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: