BridgeMD
AKAPI: Amikacin Liposome Inhalation Suspension for treatment of Mycobacterium xenopi pulmonary infection: A prospective controlled open-label randomized study
EU CTIS ID: 2023-506843-40-00
What this study is testing
to demonstrate the superiority of ARIKAYCE addition to a standard treatment in term of 3-month sputum conversion rate compared to standard regimen alone in M. xenopi pulmonary infection (MX-PD).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years old or older, must present 2020 ATS/ERS/ESCMID/IDSA criteria for nontuberculous mycobacterial pulmonary infection
- Clinical criteria Respiratory symptoms and the presence of nodular or cavitary lesion on chest x-ray, confirmed on chest high-resolution computed tomography. Lesions may also present in the form of diffuse micronodular syndrome.
- Microbiological criteria: o At least two positive cultures for MX on two sputum specimens obtained on two different days, at least separate of 7 days AND/OR o Positive culture for MX on bronchoalveolar lavage or bronchoscopic aspiration AND/OR o Transbronchial biopsy or surgical lung biopsy presenting histology in favour of mycobacterial infection (granuloma or positive Ziehl-Neelsen stain) and positive culture for MX OR biopsy showing histology compatible with mycobacterial infection and one or more sputum cultures positive for MX
- Exclusion of other diagnoses on CT scan, bronchoscopy and bacteriological specimens.
You likely can't join if
- Known hypersensitivity to one of the molecules of the study
- Limited life expectancy (e.g 36 months)
- Patients with hematologic malignancies and allogeneic haematopoietic stem cells
- Women of childbearing age and not using an effective method of contraception (Pearl Index <1%)
- The patient is treated with molecules prolonging the QT interval that cannot be replaced by another therapeutic class.
- The patient presents a heart failure with left ventricular ejection fraction less than 30%.
See the full eligibility criteria
- 18 years old or older, must present 2020 ATS/ERS/ESCMID/IDSA criteria for nontuberculous mycobacterial pulmonary infection
- Clinical criteria Respiratory symptoms and the presence of nodular or cavitary lesion on chest x-ray, confirmed on chest high-resolution computed tomography. Lesions may also present in the form of diffuse micronodular syndrome.
- Microbiological criteria: o At least two positive cultures for MX on two sputum specimens obtained on two different days, at least separate of 7 days AND/OR o Positive culture for MX on bronchoalveolar lavage or bronchoscopic aspiration AND/OR o Transbronchial biopsy or surgical lung biopsy presenting histology in favour of mycobacterial infection (granuloma or positive Ziehl-Neelsen stain) and positive culture for MX OR biopsy showing histology compatible with mycobacterial infection and one or more sputum cultures positive for MX
- Exclusion of other diagnoses on CT scan, bronchoscopy and bacteriological specimens.
- Known hypersensitivity to one of the molecules of the study
- Limited life expectancy (e.g 36 months)
- Patients with hematologic malignancies and allogeneic haematopoietic stem cells
- Women of childbearing age and not using an effective method of contraception (Pearl Index <1%)
- The patient is treated with molecules prolonging the QT interval that cannot be replaced by another therapeutic class.
- The patient presents a heart failure with left ventricular ejection fraction less than 30%.
- Relapse of MX lung infection
- Treatment with molecules able to interfere with cytochrome P450 that cannot be replaced by another therapeutic class
- HIV 1 and 2 human immunodeficiency virus infection
- Renal failure with creatinine clearance less than 30 mL/min
- Pregnancy and breastfeeding
- Cystic fibrosis
- Contraindications to one of the antibiotic
- Inability to comply with the requirements of the protocol, especially substance abuse, according to the investigator.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.