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New treatment option for Nontuberculous Mycobacterium Infection
Official title IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
ClinicalTrials.gov ID: NCT04294043
What this study is testing
What is Gallium nitrate?
Gallium nitrate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nontuberculous mycobacterium infection.
Also referred to as Ga, GaN3O9.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for Treatment-Naïve NTM Cohort
- 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
You likely can't join if
- Treatment-Naïve NTM Cohort
- 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...
See the full eligibility criteria
Who can join
- for Treatment-Naïve NTM Cohort
- 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...
- The two most recent NTM culture results from sputum or BAL taken at least 28 days apart are positive. 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...
- 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 for Treatment-Refractory NTM Cohort
- 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
What rules you out
- Treatment-Naïve NTM Cohort
- 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 treatment 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...
- 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...
- 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 Exclusion Criteria Treatment-Refractory NTM Cohort
- 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 treatment 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...
- 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...
- New initiation of chronic CF therapy (e.g., CFTR modulators, ibuprofen, inhaled tobramycin, Cayston, etc.) within 28 days prior to Visit 1 (Day 1)
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Denver, Colorado, United States
- Baltimore, Maryland, United States
- Minneapolis, Minnesota, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- Burlington, Vermont, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Denver, Colorado, United States; Baltimore, Maryland, United States; Minneapolis, Minnesota, United States; Columbus, Ohio, United States; Pittsburgh, Pennsylvania, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.