Ongoing studies
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Prospective, Investigator-Initiated Trial to Assess the Efficacy, Safety, and Pharmacokinetics of Epetraborole in Patients with Mycobacterium abscessus Lung Disease: REBOUND Study
- Primary Investigator: Kevin Winthrop, MD, MPH
- Funder: AN2 Therapeutics, Inc.
- Project Summary: This multi-site, double-blind, randomized, placebo-controlled, parallel-group, prospective, investigator-initiated trial is designed to evaluate epetraborole (EBO) monotherapy for the treatment of Mycobacterium abscessus complex (MABc) lung disease. The primary outcome is clinical response, defined as symptom improvement.
- Clinicaltrials.gov link: https://clinicaltrials.gov/study/NCT07301320
CRISPR detection of circulating cell-free Mycobacterium avium complex (MAC) DNA for rapid diagnosis and monitoring of MAC pulmonary disease (CRISPR)
- Primary Investigator: Kevin Winthrop, MD, MPH; Bo Ning, PhD
- Funder: NIH/NIAID
- Project Summary: This multi-site, observational study is designed to validate the detection of MAC cell-free DNA (cfDNA) in blood samples from patients with MAC pulmonary disease using a retrospective cohort, and to monitor disease during treatment using longitudinal samples from a prospective cohort. The primary outcome is the change from MAC-cfDNA positive to negative from baseline to 12 months.
- RePORTER link: https://reporter.nih.gov/search/gejk6PoNaUiqgzX9NNlljA/project-details/10882269
Mycobacterium avium complex pulmonary infection: immunologic and transcriptomic signatures of disease and treatment response (IMMTR)
- Primary Investigators: Kevin Winthrop, MD, MPH; David Lewinsohn, MD, PhD; Shannon McWeeney, PhD
- Funder: NIH/NIAID
- Project Summary: This multi-site, observational, prospective study utilizes a sub-population of the CRISPR Study. IMMTR is a longitudinal study designed to characterize immune profiles of disease throughout the duration of guideline treatment for MAC pulmonary disease, with the goal of defining disease signatures and biomarkers predictive of treatment response.
- RePORTER link: https://reporter.nih.gov/search/qkZj_NR2E0-0hxz8rfJUaw/project-details/11174964
Patient reported outcomes in patients with nontuberculous mycobacterial pulmonary disease (NTM PRO cohort)
- Primary Investigator: Emily Henkle, PhD, MPH
- Funder: NIH/NHLBI
- Project Summary: Patient-reported outcome (PRO) measures are a patient-centered way to measure symptoms, functioning, and symptomatic adverse events over time. This multi-site, observational study is designed to understand the trajectory of symptoms and their association with NTM pulmonary disease activity, response, and recurrence after treatment completion.
- RePORTER link: https://reporter.nih.gov/project-details/11166697
Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Drug-Induced Hearing Loss in Patients Receiving Intravenous Amikacin Therapy for Non-Tuberculous Mycobacterium Disease (SOUNDS)
- Principal Investigators: Kevin Winthrop, MD, MPH; Edwin Rubel, PhD
- Funder: National Institute on Deafness and Other Communication Disorders (NIDCD)/National Institutes of Health (NIH)
- Project Summary: The goal of this clinical trial is to test the effectiveness of the study drug, ORC-13361, in preventing hearing loss in patients with NTM infection who are undergoing treatment with IV amikacin therapy. The main questions this study aims to answer are: Is ORC-13661 effective for preventing or lessening hearing loss induced by amikacin treatment? Is ORC-13661 effective for preventing or lessening other measures of hearing impairment?
- Participating Sites: Oregon Health & Science University, University of Texas at Tyler, Mayo Clinic Rochester, National Jewish Health, Medical University of South Carolina, University of California San Francisco, Johns Hopkins University, Northwell Health, Stanford University.
- Clinicaltrials.gov link: https://clinicaltrials.gov/study/NCT05730283
Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease
- Primary Investigator: Kevin Winthrop, MD, MPH
- Funder: Nontuberculous Mycobacteria Info & Research (NTMir)
- Project Summary: This open-label, randomized controlled trial tests whether hypertonic saline helps improve symptoms and clearance of mycobacteria in patients with MAC lung infections. The primary outcome is acid-fast bacilli (AFB) culture conversion.
- Clinicaltrials.gov link: https://clinicaltrials.gov/study/NCT04921943
Mycobacterium Avium Complex Core
- Primary Investigator: Cara Varley, MD, MPH
- Funder: National Heart, Lung, and Blood Institute: K23 HL161495
- Project Summary: Researchers at Oregon Health & Science University have designed a study to identify the most important outcome measurement instruments for Mycobacterium avium complex (MAC) pulmonary disease research. The goal is to gather opinions about potential measurement instruments from many types of people involved with MAC-PD, and for the group to reach an agreement about which instruments should be used. The research team hopes the results will help patients manage pulmonary MAC disease in both the short term and the long term. The study is currently enrolling.
- Participation Links: https://ohsu-psu-sph.org/research/cids/research-projects/; https://redcap.link/maccor
