Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection

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.

NCT Number	NCT06585020
Lead Sponsor	Centre Hospitalier Universitaire, Amiens Collaborators: University Hospital, Angers, Hospital Avicenne, University Hospital, Bordeaux, University Hospital, Brest, Centre Hospitalier Intercommunal de Compiègne-Noyon, Créteil Hospital, Centre Hospitalier Universitaire Dijon, University Hospital, Grenoble, Centre Hospitalier le Mans, Hôpital de la Croix-Rousse, APHM - Nord, Hôpital Saint Joseph, CH Mulhouse, CH Orléans, Tenon Hospital, Paris, Hôpital Necker-Enfants Malades, Perpignan Hospital Center, Poitiers University Hospital, CH Pontoise, CHU de Reims, Rennes University Hospital, CHU de Rouen - Accueil, Central Hospital Saint Quentin, IHU Strasbourg, University Hospital, Tours, Abbeville Hospital Center, CH Cannes
Conditions	Mycobacterium; Xenopi, Lung Diseases
Enrollment	190 participants
Start Date	2024-10-20
Primary Completion	2026-08 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2025-11-19