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)
Chris Goss
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)
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 comple…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria for Treatment-Naïve NTM Cohort 1. Written informed consent obtained from participant or participant's legal representative 2. Be willing and able to adhere to the study visit schedule and other protocol requirements 3. All genders ≥ 18 years of age at Visit 1 4. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype 5. Documentation of persistently positive NTM culture results that are positive for the same species or sub-species (either M. avium complex, M. abscessus complex, or both M. avium and M. abscessus). Persis…
Interventions
- DrugGallium nitrate
Study subjects will receive an infusion of gallium nitrate.
Locations (10)
- University of Alabama at BirminghamBirmingham, Alabama
- National Jewish HealthDenver, Colorado
- Johns Hopkins UniversityBaltimore, Maryland
- The Minnesota Cystic Fibrosis CenterMinneapolis, Minnesota
- Nationwide Children's HospitalColumbus, Ohio
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania