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New treatment option for Mycobacterium Abscessus Infection
Official title Epetraborole in Patients With Mycobacterium Abscessus Lung Disease
ClinicalTrials.gov ID: NCT07301320
What this study is testing
What is Epetraborole?
Epetraborole is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for mycobacterium abscessus infection.
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
- This double-blind, randomized, placebo-controlled, parallel-group, multicenter, prospective, investigator-initiated trial will evaluate epetraborole (EBO) monotherapy in the treatment of adults with Mycobacterium abscessus complex (MABc) Lung Disease (LD) of mild to moderate severity. For this study, two EBO oral dose regimens will be studied in patients with MABc-LD, each compared to a placebo group (ie, 4 treatment groups): 500 mg daily and 750 mg daily.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Male or female patients who are 18 years of age or older.
- Willing and able to provide written informed consent.
- Patients with MABc lung disease, meeting the following (a) Microbiological, (b) Clinical, (c) Radiographic a. Microbiological criteria: i...
- Patients who, in the opinion of the investigator, will not require initiation of guideline-directed antibiotic therapy for treatment of MABc-LD...
- Patients who are willing to comply with all the study activities and procedures throughout the duration of the study.
You likely can't join if
- Patients with a presence of any suspected or confirmed disease or condition at Screening or the time of randomization that, in the opinion of the...
- Radiographic presence of cavitary disease (defined as a patient with one or more cavities \>2 cm internal diameter)
- Cystic fibrosis or other inherited disorders of airway ciliary dysfunction (e.g., primary ciliary dyskinesia)
- Active allergic bronchopulmonary mycosis
- Anticipated or planned lung surgery for treatment of MABc lung disease
- Disseminated MABc infection, or other known or suspected non-pulmonary source of infection (e.g., infective endocarditis, osteomyelitis, meningitis...
See the full eligibility criteria
Who can join
- Male or female patients who are 18 years of age or older.
- Willing and able to provide written informed consent.
- Patients with MABc lung disease, meeting the following (a) Microbiological, (b) Clinical, (c) Radiographic a. Microbiological criteria: i. Documentation of at least 1 Pre-Study MABc-positive respiratory specimen (sputum...
- Patients who, in the opinion of the investigator, will not require initiation of guideline-directed antibiotic therapy for treatment of MABc-LD within the next 6 months, and for whom a delay, in order for the subject to...
- Patients who are willing to comply with all the study activities and procedures throughout the duration of the study.
- Patients must agree to use an effective method of birth control, if applicable, as follows: Females of childbearing potential (FOCPs; defined in Appendix 1, Contraception Requirements) must commit to either sexual...
- Males who are sexually active with a FOCP must agree to use an effective barrier method of contraception (defined in Contraception Requirements) from Screening through the EOS Visit
- Patients expected to survive with continued antimycobacterial therapy and appropriate supportive care from Screening through the LFU Visit, in the judgment of the Investigator.
What rules you out
- Patients with a presence of any suspected or confirmed disease or condition at Screening or the time of randomization that, in the opinion of the Investigator, may confound the assessment of symptom-based clinical...
- Radiographic presence of cavitary disease (defined as a patient with one or more cavities \>2 cm internal diameter)
- Cystic fibrosis or other inherited disorders of airway ciliary dysfunction (e.g., primary ciliary dyskinesia)
- Active allergic bronchopulmonary mycosis
- Anticipated or planned lung surgery for treatment of MABc lung disease
- Disseminated MABc infection, or other known or suspected non-pulmonary source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, or urinary tract infection) requiring non-study antimicrobial therapy
- Concomitant pulmonary infection requiring antimicrobial therapy, including infection caused by fungi, viruses, non-MABc mycobacteria (e.g., Mycobacterium tuberculosis, Mycobacterium avium intracellulare, Mycobacterium...
- Patients on brensocatib who have not been on a stable dose for at least 12 weeks.
- Patients with active pulmonary malignancy (primary or metastatic) or any malignancy that required or would require chemotherapy or radiation therapy within 1 year prior to randomization through the LFU Visit.
- Patients with creatinine clearance (CrCl) of \<30 mL/min, as estimated by the Cockcroft-Gault formula, at Screening: Estimated CrCl (mL/min) = (140 - Age [years]) × Actual Body Weight [kg] × [0.85 if Female]) / (72 ×...
- Patients with any of the following hematological findings:
- Hemoglobin \<11.0 g/dL or \<6.83 mmol/L.
- Donation of blood or plasma within 28 days prior to randomization; or symptomatic loss of blood or hemorrhage within 28 days prior to randomization.
- Pre-existing (inborn or acquired) disorder of hematopoiesis that could substantially worsen the effect of EBO on hemoglobin levels or potentially prevent hemoglobin recovery post cessation of treatment, for example...
- Patients with severe hemoptysis within 28 days prior to randomization, defined as \>100 mL (approximately \>7 tbsp blood) over any 24-hour period.
- Patients with severe hepatic impairment, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × upper limit of normal (ULN) or total bilirubin \>2 × ULN, or clinical signs of cirrhosis...
- Patients who are pregnant or breastfeeding.
- Patients with a mean QT interval corrected using Fridericia's formula (QTcF) \>500 msec based 12-lead ECG at Screening.
- Patients with an immunodeficiency or an immunocompromised condition and risk for an opportunistic pulmonary infection, including:
- History of lung transplantation
- Known history of human immunodeficiency virus (HIV) infection plus either an active acquired immunodeficiency syndrome (AIDS)-defining illness in the past 12 months, or a known cluster of differentiation 4 (CD4) count...
- Neutropenia at Screening (absolute neutrophil count \<1,000 neutrophils/mm3)
- Use of immunosuppressive therapy at Screening that in the opinion of the Investigator may place the patient at risk for an opportunistic pulmonary infection, including transplant rejection medication and chronic...
- Patients with an anticipated start of new non-study antimycobacterial therapy to be administered at any time between Screening and EOT.
- Patients who have participated in a clinical trial of an investigational agent within 30 days (or 5 half-lives, whichever is longer) prior to Screening.
- Patients with any prior exposure to epetraborole.
- Patients with any condition that, in the opinion of the Investigator, interferes with the ability to safely complete the study or adhere to study requirements, including the patient's inability or unwillingness to...
- Patients with hypersensitivity to any EBO excipient (e.g., microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol...
- Patients with a history of eosinophilic interstitial pneumonitis For eligibility purposes, vital signs, clinical laboratory tests, and ECGs may be repeated once if an abnormal result is observed at the initial reading...
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, 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 Portland, Oregon, United States. 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.