NCT04294043

IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)

A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chris Goss · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM. Funding Source - FDA Office of Orphan Products Development (OOPD)

Detailed description

This is a prospective, multicenter open-label study in adults with CF who are colonized with M. avium complex and/or M. abscessus complex. Participants are enrolled into one of the two cohorts: 1. Treatment-Naïve NTM Cohort: participants with persistently positive NTM culture results (either M. avium complex, M. abscessus complex, or both M. avium and M. abscessus) who had never been treated for current NTM species or previous treatment was associated with clearance of NTM. 2. Treatment-Refractory NTM Cohort: participants with persistently positive NTM culture results (either M. avium complex, M. abscessus complex, or both M. avium and M. abscessus) whose treatment failed to respond to 12 months of NTM guideline-based therapy or currently receiving treatment with guideline-based antibiotics for \> 12 months. 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.

Conditions

• Nontuberculous Mycobacterium Infection

Interventions

Type	Name	Description
DRUG	Gallium nitrate	Study subjects will receive an infusion of gallium nitrate.

Timeline

• Start date: 2021-06-17
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2020-03-03
• Last updated: 2025-10-01

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study