IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
This study is testing the safety and how well a medication called gallium nitrate works in adults with cystic fibrosis (CF) who also have a lung infection called Nontuberculous Mycobacterium (NTM). You might be able to join if you are 18 or older, have CF, and have NTM. The study is looking to see if gallium nitrate causes any side effects and if it helps treat the NTM infection. Participants will receive two 5-day infusions of gallium nitrate. The study plans to enroll 40 people, but its current recruitment status is unclear.
- Study design
- This is an open-label study, meaning both you and the study team will know you are receiving gallium nitrate. It plans to enroll 40 adult participants.
- What's involved
- You will receive two 5-day infusions of IV gallium nitrate. You will also need to attend study visits and follow other protocol requirements.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track adverse events (side effects) from when you start treatment until Day 57.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04294043
IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
Recruiting
PHASE1Ages 18+InterventionalTreatmentChris GossInvestigator-initiated
~40 participants
Updated 2025-10-01 on ClinicalTrials.gov
What's tested:Gallium nitrate
At a glance
Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events of Special Interest
Measured over Baseline to Day 57
Conditions
Where it's being run
10 sites across 10 statesAlabama1
Colorado1
Maryland1
Minnesota1
Ohio1
Pennsylvania1
South Carolina1
Texas1
Study leadership
- Christopher H. Goss, MD, MSc · PRINCIPAL_INVESTIGATOR · University of Washington, Seattle Children's Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
Hemoglobin \<10g/dL
Platelets \<100,000/mm3
Absolute neutrophil count \< 1500/mm3
Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), or total bilirubin ≥3 x upper limit of normal
Serum creatinine \> 2.0 mg/dl and ≥1.5 x upper limit of normal
Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal) 2. History of solid organ or hematological transplantation 3. Use of bisphosphonates within 7 days prior to Day 1 4. Known sensitivity to gallium 5. Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1 6. In the opinion of the Investigator, features of active NTM disease are present (e.g., clinical worsening is likely due to NTM disease despite definitive treatment of co-pathogens and/or acute exacerbations) 7. Undergoing treatment for NTM disease or anticipate beginning treatment within 3 months 8. Current diagnosis of osteoporosis 9. For people of childbearing potential:
Positive pregnancy test at Visit 1 or
Lactating or
Unwilling to practice a medically acceptable form of contraception (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal during the study 10. For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study 11. Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives 12. New initiation of chronic CF therapy (e.g., CFTR modulators, ibuprofen, azithromycin, inhaled tobramycin, Cayston, etc.) within 28 days prior to Visit 1 (Day 1) 13. Use of azithromycin within 14 days prior to the screening visit
Hemoglobin \<10g/dL
Platelets \<100,000/mm3
Absolute neutrophil count \< 1500/mm3
Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), or total bilirubin ≥3 x upper limit of normal
Serum creatinine \> 2.0 mg/dL and ≥1.5 x upper limit of normal
Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal) 2. History of solid organ or hematological transplantation 3. Use of bisphosphonates within 7 days prior to Day 1 4. Known sensitivity to gallium 5. Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1 6. Current diagnosis of osteoporosis 7. For people of childbearing potential:
Positive pregnancy test at Visit 1 (Day 1) or
Lactating or
Unwilling to practice a medically acceptable form of contraception (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal during the study 8. For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study 9. Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives 10. New initiation of chronic CF therapy (e.g., CFTR modulators, ibuprofen, inhaled tobramycin, Cayston, etc.) within 28 days prior to Visit 1 (Day 1)
What this trial measures
- Adverse Events of Special InterestBaseline 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.