Nontuberculous Mycobacterium InfectionPhase 1ABATENCT04294043
IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
A Phase 1 study testing Gallium nitrate in people with Nontuberculous Mycobacterium Infection, run by Chris Goss at 10 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nontuberculous Mycobacterium Infection
- What is being tested?
- Gallium nitrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 Jun 2021to 31 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from participant or participant's legal representative
- Be willing and able to adhere to the study visit schedule and other protocol requirements
- All genders ≥ 18 years of age at Visit 1
- Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype
- 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). Persistently positive cultures are those which meet ONE of the following criteria, after first ignoring any negative culture results that occur within 7 days of a positive culture:
- The two most recent NTM culture results from sputum or BAL taken at least 28 days apart are positive.
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- OR
- At least one NTM culture result in the previous 4 months from sputum or BAL is positive. If there are four or more cultures in the last 12-months at least 3 out of the 4 most recent cultures must be positive for NTM. If there are three or fewer cultures in the past 12 months, then at least 2 of the 3 most recent cultures must be positive for NTM even if some of those cultures are more than 12 months ago.
- Current NTM species or subspecies has never been treated or previous treatment was associated with clearance of NTM and completed > 2 years prior to Day 1
- FEV1 ≥ 25 % of predicted value at Screening
- Able to expectorate sputum
- Clinically stable with no significant changes in health status within 7 days prior to Day 1
- Enrolled in the CFF Patient Registry (CFF PR)
- Willing to discontinue chronic azithromycin use for the duration of the study
- Written informed consent obtained from participant or participant's legal representative
- Be willing and able to adhere to the study visit schedule and other protocol requirements
- All genders ≥ 18 years of age at Visit 1
- Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype
- History of current or prior treatment for NTM pulmonary disease with M. abscessus or M avium (or both M. avium and M. abscessus)
- Previously received treatment with guideline-based antibiotics for >12 months without having treatment discontinued for reasons of culture clearance OR
- Currently receiving treatment with guideline-based antibiotics for >12 months
- FEV1 ≥ 25 % of predicted value at Screening
- Able to expectorate sputum
- Not hospitalized within 7 days prior to Day 1
- Enrolled in the CFF Patient Registry (CFF PR)
- Be willing and able to continue guideline-based antibiotic therapy for M. abscessus or M avium (or both M. avium and M. abscessus) concurrent with IV gallium, if currently on treatment
Who cannot join
- Any of the following abnormal lab values at screening:
- 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
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- Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal)
- History of solid organ or hematological transplantation
- Use of bisphosphonates within 7 days prior to Day 1
- Known sensitivity to gallium
- Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1
- 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)
- Undergoing treatment for NTM disease or anticipate beginning treatment within 3 months
- Current diagnosis of osteoporosis
- 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
- For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study
- 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
- 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)
- Use of azithromycin within 14 days prior to the screening visit
- Any of the following abnormal lab values at screening:
- 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)
- History of solid organ or hematological transplantation
- Use of bisphosphonates within 7 days prior to Day 1
- Known sensitivity to gallium
- Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1
- Current diagnosis of osteoporosis
- 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
- For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study
- 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
- New initiation of chronic CF therapy (e.g., CFTR modulators, ibuprofen, inhaled tobramycin, Cayston, etc.) within 28 days prior to Visit 1 (Day 1)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Jeanne Pinto, jpinto4@jh.edu
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Kathryn Monroe, 2056385599, kathrynmonroe@uabmc.edu
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Julie Sweet, julie.sweet@uvmhealth.org
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Ashley Warden, jonesash@musc.edu
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Diana Gilmore, diana.gilmore@nationwidechildrens.org
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Ashley Keller, Ashley.Keller@UTSouthwestern.edu
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Alix Wilson, wilsona@njhealth.org
- Recruiting
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, 55455
CF Trials Contact, cftrials@umn.edu
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Adrienne DeRicco, adrienne.dericco2@upmc.edu
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Lauren Bartlett, lrejman@uw.edu
About this study
Official title: 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)
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)
Read the 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:
- 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.
- 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.
- Conditions
- Nontuberculous Mycobacterium Infection
- Being tested
- Gallium nitrate
- Keywords
- Cystic Fibrosis, Gallium Nitrate, IV Gallium, Nontuberculous mycobacterium, NTM, Mycobacterium abscessus, mycobacterium avium
- Medical subject headings
- Mycobacterium Infections, Nontuberculous, Cystic Fibrosis, Mycobacterium avium-intracellulare Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium nitrateDrug
Also called Ga, GaN3O9, IV gallium, ganite
Study subjects will receive an infusion of gallium nitrate.
| Study group | Role | What they receive |
|---|---|---|
| Infusion of IV Gallium | Experimental | 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. Receives: Drug: Gallium nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events of Special Interest
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.
Measured: Baseline to Day 57
Secondary outcomes (2)
Clinically significant abnormal laboratory measures. (safety)
Proportion of patients experiencing clinically significant abnormal laboratory measures. Clinically significant abnormal laboratory measures are identified by the site investigator.
Measured: Baseline to Day 57
NTM clearance (efficacy)
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.
Measured: Day 6 to Day 111
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start17 Jun 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nontuberculous Mycobacterium InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chris Goss
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor-investigator, Chris Goss, Seattle Children's Hospital
- Investigators
- Christopher H. Goss, MD, MSc, Principal investigator, University of Washington, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294043
- Sponsor's protocol ID
- ABATE-IP-18
- Other IDs
- R01FD006848
- Acronym
- ABATE
- Status last verified
- Sep 2025
- First submitted
- 1 Mar 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04294043
- Acronym / sponsor ID
- ABATE / ABATE-IP-18
- Conditions
- Nontuberculous Mycobacterium Infection
- Keywords
- Cystic Fibrosis, Gallium Nitrate, IV Gallium, Nontuberculous mycobacterium, NTM, Mycobacterium abscessus, mycobacterium avium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chris GossUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infusion of IV Gallium | Experimental | Drug: Gallium nitrateGallium 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Written informed consent obtained from participant or participant's legal representative
- Be willing and able to adhere to the study visit schedule and other protocol requirements
- All genders ≥ 18 years of age at Visit 1
- Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype
- 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). Persistently positive cultures are those which meet ONE of the following criteria, after first ignoring any negative culture results that occur within 7 days of a positive culture:
Key exclusion criteria (41 listed)
- Any of the following abnormal lab values at screening:
- History of solid organ or hematological transplantation
- Use of bisphosphonates within 7 days prior to Day 1
- Known sensitivity to gallium
- Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gallium nitrateAlso: Ga, GaN3O9, IV gallium, ganiteStudy subjects will receive an infusion of gallium nitrate. | Drug | Infusion of IV Gallium |
Primary outcome
Adverse Events of Special Interest
Time frame: 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.
2 secondary outcomes
Clinically significant abnormal laboratory measures. (safety)
Time frame: Baseline to Day 57
NTM clearance (efficacy)
Time frame: Day 6 to Day 111
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher H. Goss, MD, MSc principal investigator
University of Washington, Seattle Children's Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gallium nitrate in people with Nontuberculous Mycobacterium Infection, run by Chris Goss at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natallia Cameron (206-884-7550, Natallia.Cameron@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events of Special Interest (time frame: Baseline to Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.