Clinical Research Details

Clinical Research

A study to Assess the Efficacy, Safety, and Pharmacokinetics of Orally Administered Epetraborole in Patients with Treatment-refractory Mycobacterium avium Complex Lung Disease

Study Description

This study is a Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Study. The purpose of this study is to learn about the effects of epetraborole in patients with refractory MAC, including to assess the efficacy for treating refractory MAC, to see how safe epetraborole is for patients with refractory MAC, to understand the amount of epetraborole in the body and to assess how patients feel while taking the study medicine. The study will also compare the effects of, epetraborole plus optimized background regimen (OBR), to placebo plus OBR to find out which is better for treating MAC.

Inclusion/Exclusion Criteria

Inclusion criteria: Patients with a diagnosis of treatment-refractory MAC lung disease, defined as respiratory specimen positive for MAC despite receiving a combination regimen of =2 antimycobacterial agents administered for =6 months. Exclusion criteria: Patients with a presence of any suspected or confirmed disease or condition that may confound the assessment of symptom-based clinical response, including, but not limited to, the following: • Radiographic presence of any cavity >5.0 cm internal diameter • Cystic fibrosis or other inherited disorders of airway ciliary dysfunction • Active allergic bronchopulmonary mycosis • Anticipated or planned lung surgery for treatment of MAC lung disease • Disseminated MAC infection, or other known or suspected non-pulmonary source of infection (eg, infective endocarditis, osteomyelitis, meningitis, or urinary tract infection) requiring non-study antimicrobial therapy • Concomitant pulmonary infection requiring antimicrobial therapy •Patients with active pulmonary malignancy

Open Enrollment

Contact Name: Brandi Wells
Contact Phone: (904) 244-4693
Contact Email: brandi.wells@jax.ufl.edu

Investigators


Mehdi S. Mirsaeidi, M.D., M.P.H.
Medicine