Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection
Trial Parameters
Brief Summary
Treatment of Mycobacterium xenopi (MX) lung disease is not-well- tolerated and concerned a growing number of patients, especially with chronic pulmonary diseases or immunosuppression. The outcome of these patients is poor, and treatment is very long. Indeed, this duration is based on the date of sputum conversion. Treatment should be continued until 12 months after sputum conversion. In the vast majority patients have converted after 6 months of treatment, so a 18 months duration in total. Unfortunately, few data are available for MX, as it is rare in USA, but it is the second NTM isolated in France and concerns an increasing number of patients. As it is uncommon in USA, no clinical studies conducted by the pharmaceutical laboratory will be planned. In a murine model of MX infection, the only drug which decreased the number colony formant units in mice lungs, was amikacin. Until now, amikacin was only available intravenously and used only for patients with very severe disease, because of renal and auditory toxicity. Amikacin liposome inhalation suspension (ARIKAYCE®) is amikacin sulfate encapsulated in liposomes for inhalational delivery. ARIKAYCE® increases amikacin uptake into alveolar macrophages, a refuge for NTM organisms; allows biofilm penetration; and limits systemic amikacin exposure ARIKAYCE® has already be tested in a randomized study on M. avium complex (MAC) refractory pulmonary infections. In this study, the culture conversion rate in the ARIKAYCE® group was higher than standard regimen group.
Eligibility Criteria
Inclusion Criteria: * 18 years old or older * with an highly effective or acceptable contraception * must present ATS/IDSA 2020 criteria for nontuberculous mycobacterial pulmonary infection * the NTM should be M. xenopi Exclusion Criteria: * Patients presenting any of the following criteria cannot be included: * Known hypersensitivity to one of the molecules of the study * 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 : Contraindication to the use of ARIKAYCE®: * Hypersensitivity to the active substance, to aminoglycosides or to any of the excipients listed in section 6.1 of the CPR. * Hypersensitivity to soy. * Co-administration with any other aminoglycoside, regardless of the rou