865-18 | A study to evaluate intravenous (IV) infusion of Lefamulin in hospitalized pediatric subjects receiving standard of care therapy for bacterial infection

Trial Number

865-18

Condition

Bacterial Infection

Participant Age Range

18 years and younger

Participant Gender

Any

Enrolling Participants

Yes

Overview

“A Phase 1, Open-Label, Two-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Intravenous Lefamulin in Hospitalized Pediatric Subjects Receiving Standard of Care Antibiotic Therapy for Confirmed or Suspected Infection”

Lefamulin is a novel, semi-synthetic, first-in-class pleuromutilin antibiotic for systemic use in humans. In December of 2018, Nabriva filed a New Drug Application (NDA) for use of lefamulin in the treatment of community-acquired bacterial pneumonia (CABP) in adults.This study involves giving a single IV dose of lefamulin to hospitalized pediatric subjects who are receiving standard of care systemic antibiotic therapy for the prevention or treatment of a confirmed or suspected bacterial infection. The results of this study will support dose selection for future pediatric studies of lefamulin.