Actively Recruiting
A Phase 1b Multi-center Study of Intravenous Gallium Nitrate in Adults With Cystic Fibrosis Colonized With Nontuberculous Mycobacteria
Led by Chris Goss · Updated on 2025-10-01
40
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Chris Goss
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the safety and tolerability of two 5-day cycles of intravenous (IV) gallium in adults with cystic fibrosis (CF) who are infected with nontuberculous mycobacteria (NTM). The study focuses on patients colonized with Mycobacterium avium complex and/or Mycobacterium abscessus complex, including those who are treatment-na efve and those with treatment-refractory infections. This phase 1b, multicenter, open-label study is funded by the FDA Office of Orphan Products Development (OOPD).
CONDITIONS
Brief Title
IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained from participant or legal representative
- Willing and able to follow study schedule and protocol requirements
- Adults aged 18 years or older
- Confirmed diagnosis of cystic fibrosis with clinical features consistent with CF
- Persistently positive NTM culture results for M. avium complex, M. abscessus complex, or both
- For treatment-na�efve cohort: no prior treatment for current NTM species or previous treatment cleared NTM and completed over 2 years ago
- For treatment-refractory cohort: history of treatment with guideline-based antibiotics for over 12 months without clearance or currently receiving such treatment
- Forced expiratory volume in 1 second (FEV1) at least 25% of predicted value at screening
- Able to expectorate sputum
- Clinically stable with no significant health changes within 7 days before Day 1
- Enrolled in the Cystic Fibrosis Foundation Patient Registry
- Willing to discontinue chronic azithromycin use during study (na�efve cohort)
- Willing to continue guideline-based antibiotic therapy concurrent with IV gallium if currently on treatment (refractory cohort)
You will not qualify if you...
- Abnormal lab values at screening including low hemoglobin, low platelets, low neutrophil count, elevated liver enzymes or bilirubin, high serum creatinine, or low ionized calcium
- History of solid organ or blood cell transplantation
- Use of bisphosphonates within 7 days before Day 1
- Known allergy or sensitivity to gallium
- Participation in other investigational drug studies within 28 days before Day 1
- Signs of active NTM disease or clinical worsening despite treatment
- Currently undergoing or planning treatment for NTM disease within 3 months (na�efve cohort)
- Current diagnosis of osteoporosis
- For people who can become pregnant: positive pregnancy test, breastfeeding, or unwillingness to use effective contraception during study
- For people who can father a child: unwillingness to use adequate contraception during study
- Other conditions that would make participation unsafe or affect study results as judged by investigator
- Recent new initiation of chronic CF therapies within 28 days before study start
- Use of azithromycin within 14 days before screening (na�efve cohort)
- Hospitalization within 7 days before Day 1 (refractory cohort)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 cycles of 5 days each
Participants receive two cycles of intravenous gallium nitrate infusions, each cycle lasting 5 days. The infusions are administered continuously over 24 hours using an ambulatory infusion pump.
2 infusion cycles, each lasting 5 days
Duration - Up to 57 days after baseline
Participants are monitored for safety and treatment effects following completion of the gallium infusions.
Visits for safety and efficacy assessments up to Day 57 and Day 111
Trial Site Locations
Total: 10 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
3
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
4
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
5
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
6
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
7
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
8
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
9
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
10
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
N
Natallia Cameron
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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