IV Gallium Study for Patients with Cystic Fibrosis Who Have NTM (ABATE Study)
- Registration Number
- NCT04294043
- Lead Sponsor
- Chris Goss
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Infusion of IV Gallium Gallium nitrate Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device using an ambulatory infusion pump infused over 24 hours for 5 sequential days for each cycle. There is a maximum of 2 cycles.
- Primary Outcome Measures
Name Time Method Adverse Events of Special Interest Baseline to Day 57 Proportion of patients experiencing one or more Adverse Events of Special Interest (AESI). AESIs include the occurrence of either (1) a serious adverse event (SAE) of grade 3 or higher including hospitalizations or (2) study drug discontinuation because of an AE.
- Secondary Outcome Measures
Name Time Method NTM clearance (efficacy) Day 6 to Day 111 Proportion of subjects who were NTM culture positive at baseline and have at least 2 sequential negative NTM cultures between visits 2 (Day 6) and 7 (Day 111). Those negative cultures must be at least 2 weeks apart.
Clinically significant abnormal laboratory measures. (safety) Baseline to Day 57 Proportion of patients experiencing clinically significant abnormal laboratory measures. Clinically significant abnormal laboratory measures are identified by the site investigator.
Trial Locations
- Locations (10)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
The Minnesota Cystic Fibrosis Center
🇺🇸Minneapolis, Minnesota, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States