Actively Recruiting
IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
Led by Chris Goss · Updated on 2025-10-01
40
Participants Needed
10
Research Sites
301 weeks
Total Duration
On this page
Sponsors
C
Chris Goss
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official 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 visits and protocol requirements
- All genders 18 years or older at first visit
- Documented diagnosis of cystic fibrosis
- Persistently positive NTM culture results for same species or subspecies (M. avium complex, M. abscessus complex, or both), meeting specified culture frequency criteria
- For treatment-naïve cohort: no prior treatment or prior treatment completed over 2 years ago with clearance
- For treatment-refractory cohort: history of or current treatment for NTM pulmonary disease with guideline-based antibiotics for over 12 months
- Forced expiratory volume (FEV1) at least 25% of predicted value at screening
- Able to expectorate sputum
- Clinically stable with no significant health changes within 7 days before first treatment (treatment-naïve cohort)
- Enrolled in Cystic Fibrosis Foundation Patient Registry
- Willing to stop chronic azithromycin use during study (treatment-naïve cohort)
- Willing and able to continue guideline-based antibiotics during IV gallium treatment if currently on treatment (treatment-refractory cohort)
You will not qualify if you...
- Abnormal lab values at screening including hemoglobin <10g/dL, platelets <100,000/mm3, neutrophil count <1500/mm3, liver enzymes or bilirubin ≥3 times upper limit normal, serum creatinine >2.0 mg/dL and ≥1.5 times upper limit normal, or low ionized calcium if tested
- History of solid organ or blood transplantation
- Use of bisphosphonates within 7 days prior to first treatment
- Known allergy or sensitivity to gallium
- Participation in investigational drug trials within 28 days prior to first treatment
- Signs of active worsening NTM disease despite treatment of other infections
- Currently undergoing or planning to begin treatment for NTM within 3 months (treatment-naïve cohort)
- Current diagnosis of osteoporosis
- For people who can become pregnant: positive pregnancy test, lactating, or unwilling to use medically acceptable contraception unless sterilized or postmenopausal
- For people who can father children: unwilling to use adequate contraception during study
- Any condition that might make participation unsafe or affect study results as judged by investigator
- New start of chronic CF therapies within 28 days prior to first treatment
- Use of azithromycin within 14 days prior to screening (treatment-naïve cohort)
- Hospitalization within 7 days prior to first treatment (treatment-refractory cohort)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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