A Phase 1b, Multi-center Study of IV Gallium Nitrate in Patients with Cystic Fibrosis who are colonized with Nontuberculous Mycobacteria (the ABATE study)

Date Added
September 1st, 2022
PRO Number
Pro00123092
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis, Nontuberculous mycobacteria (NTM)
Summary

This is a prospective, multicenter open-label study in adults with CF who are colonized with NTM. Subjects will receive two 5-day infusion cycles of IV gallium. The study will evaluate the safety and antimycobacterial effect of two 5-day infusions of IV gallium. Subjects will be on study for up to 148 days, with a screening period of up to 7 days and active study period up to 20 days. About 40 people with CF who are 18 years of age or older will take part in this study at about 10 hospitals and clinics around the country.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)

Date Added
February 8th, 2021
PRO Number
Pro00107820
Researcher
Patrick Flume

List of Studies


Keywords
Nontuberculous mycobacteria (NTM)
Summary

The purpose of this study is to evaluate the effect and safety of amikacin liposome inhalation suspension (ALIS) study treatment on patient-reported symptoms in subjects newly diagnosed with NTM lung infection caused by MAC who have not started standard treatment. Around 250 subjects 18 years and older with newly diagnosed NTM lung infection caused by MAC who have not started standard treatment are expected to participate in this study. The study will last around 17.5 months from the Screening visit to the end of the study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu