Phase 3
N=137
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02369159 ↗Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. — 22; 5; 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Peramivir (Drug); Oseltamivir (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- BioCryst Pharmaceuticals
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. |
22; 5; 2; 0; 8; 4 | — |
| SECONDARY Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose |
56200; 71200; 87000; 72400; 53300; 68100 | — |
| SECONDARY Time to Resolution of Fever |
39.7; 61.8; 58.8; 16.0; 36.3; 29.7 | — |
| SECONDARY Time to Resolution of Influenza Symptoms |
76.1; 98.9; 94.1; 20.7; 66.6; 134.4 | — |
| SECONDARY Time to Reduction in Viral Shedding |
8; 1; 23; 2; 27; 6 | — |
| SECONDARY Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment. |
4.38; 4.50; -2.75; -3.25; -3.75; -4.00 | — |
| SECONDARY Influenza-Related Complications Assessment. |
3; 0; 2; 0; 0; 0 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT02369159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.