- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02369159
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
February 26, 2021 updated by: BioCryst Pharmaceuticals
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
137
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pretoria, South Africa
- Peramivir Investigative Site
-
-
-
-
Louisiana
-
Shreveport, Louisiana, United States
- Peramivir Investigative Site
-
-
Ohio
-
Dayton, Ohio, United States
- Peramivir Investigative Site
-
-
Pennsylvania
-
Smithfield, Pennsylvania, United States
- Peramivir Investigative Site
-
-
Texas
-
Houston, Texas, United States
- Peramivir Investigative Site
-
San Antonio, Texas, United States
- Peramivir Investigative Site
-
Splendora, Texas, United States
- Peramivir Investigative Site
-
-
Utah
-
Draper, Utah, United States
- Peramivir Investigative Site
-
Salt Lake City, Utah, United States
- Peramivir Investigative Site
-
South Jordan, Utah, United States
- Peramivir Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- 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
- Onset of symptoms no more than 72 hours before presentation for screening for subjects < 2 years old.
Key Exclusion Criteria:
- Pregnant or breast-feeding females
- Development of symptoms while hospitalized
- Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications
- Presence of immunocompromised status
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
|
Active Comparator: Oseltamivir
Subjects randomized to oral oseltamivir will receive an age appropriate dose twice daily for 5 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Time Frame: 14 days
|
Safety evaluation included assessment of Adverse Events (AEs).
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Time Frame: Change from baseline assessed on days 3, 7 and 14.
|
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.
|
Time to Reduction in Viral Shedding
Time Frame: 14 days
|
Assessment of viral shedding in bilateral, mid-nasal swab specimens taken at baseline and then on Day 3, 7 and 14.
|
14 days
|
Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose
Time Frame: up to 6 hours post peramivir infusion
|
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
|
Time to Resolution of Fever
Time Frame: 14 days
|
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
|
Time to Resolution of Influenza Symptoms
Time Frame: 14 days
|
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
|
Influenza-Related Complications Assessment.
Time Frame: 14 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Vanchiere, MD, PhD, Chief, Pediatric Infectious Diseases, Louisiana State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2015
Primary Completion (Actual)
October 28, 2019
Study Completion (Actual)
May 14, 2020
Study Registration Dates
First Submitted
February 17, 2015
First Submitted That Met QC Criteria
February 17, 2015
First Posted (Estimate)
February 23, 2015
Study Record Updates
Last Update Posted (Actual)
March 23, 2021
Last Update Submitted That Met QC Criteria
February 26, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCX1812-305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Influenza
-
Novartis VaccinesCompletedInfluenza | Seasonal Influenza | Human Influenza | Influenza Due to Unspecified Influenza VirusBelgium
-
Gamaleya Research Institute of Epidemiology and...CompletedInfluenza A | Influenza A Virus Infection | Influenza Epidemic | Influenza H5N1Russian Federation
-
Vanderbilt University Medical CenterHuman Vaccines ProjectCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Influenza Type B | Influenza A H3N2 | Influenza A H1N1United States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Influenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH)CompletedInfluenza AUnited States
Clinical Trials on Oseltamivir
-
Centre of Postgraduate Medical EducationUnknownInfluenza | Prevention | ExposurePoland
-
GlaxoSmithKlineCompleted
-
Hoffmann-La RocheCompletedInfluenzaItaly, United States, Spain, Hungary, France, Lithuania, Romania, Poland, Denmark
-
The University of Hong KongCompleted
-
Capital Medical UniversityUnknown
-
Jiangxi Qingfeng Pharmaceutical Co. Ltd.Qingdao Municipal Hospital; Beijing Luhe Hospital; Cangzhou People's Hospital; First... and other collaboratorsUnknown
-
Guangdong Raynovent Biotech Co., LtdCompleted
-
Laboratorios Andromaco S.A.CompletedBioequivalenceIndia
-
Capital Medical UniversityCompleted
-
The Affiliated Hospital of Qingdao UniversityCompletedHealthy SubjectsChina