Clinical trial NCT02635724: Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza
Official title: A Phase 3, Multicenter, Single-arm, Open-label, Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of Intravenous Peramivir in Elderly Subjects With Acute Uncomplicated Influenza Infection and in Subjects With Acute Uncomplicated Influenza Infection at Higher Risk for Influenza Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Acute uncomplicated
Elderly
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-12-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of 600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza infection and in subjects with acute uncomplicated influenza infection at higher risk for influenza complications. All subjects will receive IV peramivir.


Eligibility criteria: Inclusion Criteria:

* A positive influenza Rapid Antigen Test (RAT) and/or a FDA-approved PCR test and at least one clinical sign or symptom consistent with acute influenza infection as listed below OR
* Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature ≥ 100°F (37.8°C) with at least one respiratory symptom of at least moderate severity (cough or rhinitis) and at least one constitutional symptom of at least moderate severity (myalgia \[aches and pains\], headache, feverishness, or fatigue)
* Influenza symptom onset \< 48 hours. However, due to historically delayed presentation for medical care in the adult population, approximately 20% of the elderly population may be enrolled with symptoms starting \> 48-hours but ≤ 72-hours

Exclusion Criteria:

* Women who plan to breast-feed for the first 48 hours after study drug administration
* Subjects requiring hospital admission to treat medical condition(s) which could represent complications of influenza.
* Recent worsening of any chronic medical condition consistent with complications of influenza
* Current evidence of a bacterial infection requiring antibiotic treatment

Primary outcomes:
measure: Safety and Tolerability, as Measured by the Number of Adverse Events.
timeFrame: 14 days
Secondary outcomes:
measure: Plasma Exposure of IV Peramivir as Measured by Drug Concentrations up to 3 Hours Post Infusion
timeFrame: up to 3 hours post peramivir infusion
measure: Time to Resolution of Fever
timeFrame: 14 days
measure: Time to Resolution of Influenza Symptoms
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: Time to Reduction in Viral Shedding
timeFrame: 14 days
measure: Incidence of Influenza-related Complications
timeFrame: 14 days
measure: Time to Return to Usual Activities
timeFrame: 14 days
Other outcomes:
Locations:
city: Brooksville
country: United States
facility: Peramivir Investigational Site
state: Florida
city: Lakeland
country: United States
facility: Peramivir Investigational Site
state: Florida
city: Miami
country: United States
facility: Peramivir Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Peramivir Investigational Site
state: Florida
city: Tampa
country: United States
facility: Peramivir Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: Peramivir investigative site
state: Indiana
city: Detroit
country: United States
facility: Peramivir investigative site
state: Michigan
city: Dayton
country: United States
facility: Peramivir Investigational Site
state: Ohio
city: Smithfield
country: United States
facility: Peramivir investigative site
state: Pennsylvania
city: Houston
country: United States
facility: Peramivir Investigational 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 Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Peramivir Investigational Site
state: Utah
city: South Jordan
country: United States
facility: Peramivir investigative site
state: Utah
Study officials:
affiliation: Prof., Dept. of Emergency Medicine, Oakland University, William Beaumont School of Medicine, Royal Oak, MI
name: Carol Clark, MD
role: PRINCIPAL_INVESTIGATOR
References: