Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection

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.

Conditions

• Mycobacterium; Xenopi
• Lung Diseases

Interventions

DRUG

Arikayce

Treatment regimens containing three molecules, rifampicin, ethambutol, and clarithromycin with ARIKAYCE® during the 6 first months of treatment. After having confirmed the presence of all inclusion criteria and the absence of all exclusion criteria, and after having obtained the patient's free and informed consent, the patient will be included and randomized to one of the treatment regimens.

DRUG

standard treatment

treatment regimens containing three molecules, rifampicin, ethambutol, and clarithromycin during the 6 first months of treatment. After having confirmed the presence of all inclusion criteria and the absence of all exclusion criteria, and after having obtained the patient's free and informed consent, the patient will be included and randomized to one of the treatment regimens.

Sponsors & Collaborators

• University Hospital, Angers

  collaborator OTHER_GOV

• Hospital Avicenne

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• University Hospital, Brest

  collaborator OTHER

• CH Compiègne

  collaborator UNKNOWN

• Créteil Hospital

  collaborator OTHER

• Centre Hospitalier Universitaire Dijon

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• Centre Hospitalier le Mans

  collaborator OTHER

• Hôpital de la Croix-Rousse

  collaborator OTHER

• APHM - Nord

  collaborator UNKNOWN

• Hôpital Saint Joseph

  collaborator UNKNOWN

• CH Mulhouse

  collaborator UNKNOWN

• CH Orléans

  collaborator UNKNOWN

• Tenon Hospital, Paris

  collaborator OTHER

• Hôpital Necker-Enfants Malades

  collaborator OTHER

• Centre hospitalier de Perpignan

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• CH Pontoise

  collaborator UNKNOWN

• CHU de Reims

  collaborator OTHER

• Rennes University Hospital

  collaborator OTHER

• CHU de Rouen - Accueil

  collaborator OTHER

• Central Hospital Saint Quentin

  collaborator OTHER_GOV

• IHU Strasbourg

  collaborator OTHER

• University Hospital, Tours

  collaborator OTHER

• CH Abbeville

  collaborator UNKNOWN

• CH Cannes

  collaborator UNKNOWN

• Centre Hospitalier Universitaire, Amiens

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-20

Primary Completion

2026-08-31

Completion

2027-08-31

Countries

• France

Study Locations