Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2027

Conditions
Mycobacterium; XenopiLung 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.

Trial Locations (1)

80054

CHU Amiens-Picardie, Amiens

All Listed Sponsors
collaborator

University Hospital, Angers

OTHER_GOV

collaborator

Hospital Avicenne

OTHER

collaborator

University Hospital, Bordeaux

OTHER

collaborator

University Hospital, Brest

OTHER

collaborator

CH Compiègne

UNKNOWN

collaborator

Créteil Hospital

OTHER

collaborator

Centre Hospitalier Universitaire Dijon

OTHER

collaborator

University Hospital, Grenoble

OTHER

collaborator

Centre Hospitalier le Mans

OTHER

collaborator

Hôpital de la Croix-Rousse

OTHER

collaborator

APHM - Nord

UNKNOWN

collaborator

Hôpital Saint Joseph

UNKNOWN

collaborator

CH Mulhouse

UNKNOWN

collaborator

CH Orléans

UNKNOWN

collaborator

Tenon Hospital, Paris

OTHER

collaborator

Hôpital Necker-Enfants Malades

OTHER

collaborator

Centre hospitalier de Perpignan

OTHER

collaborator

Poitiers University Hospital

OTHER

collaborator

CH Pontoise

UNKNOWN

collaborator

CHU de Reims

OTHER

collaborator

Rennes University Hospital

OTHER

collaborator

CHU de Rouen - Accueil

OTHER

collaborator

Central Hospital Saint Quentin

OTHER_GOV

collaborator

IHU Strasbourg

OTHER

collaborator

University Hospital, Tours

OTHER

collaborator

CH Abbeville

UNKNOWN

collaborator

CH Cannes

UNKNOWN

lead

Centre Hospitalier Universitaire, Amiens

OTHER

NCT06585020 - Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection | Biotech Hunter | Biotech Hunter