AKAPI: Amikacin Liposome Inhalation Suspension for treatment of Mycobacterium xenopi pulmonary infection: A prospective controlled open-label randomized study

Phase 1

Conditions: Mycobacterium xenopi pulmonary infection
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: CTIS2023-506843-40-00

Lead Sponsor: Centre Hospitalier Universitaire Amiens Picardie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 190

Inclusion 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.

Exclusion Criteria

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.