Actively Recruiting
Amikacin Liposome Inhalation Suspension Added to Standard Treatment for Mycobacterium Xenopi Lung Infection
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-19
190
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire, Amiens
Lead Sponsor
U
University Hospital, Angers
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating treatments for Mycobacterium xenopi (MX) lung disease, which is challenging to treat and affects many patients with chronic lung conditions or weakened immune systems. Treatment typically lasts around 18 months, based on sputum conversion, but outcomes remain poor. MX is rare in the USA but more common in France. Amikacin, an antibiotic, showed promise in animal models but was previously limited due to toxicity when given intravenously. A new form, amikacin liposome inhalation suspension (ARIKAYCE4), delivers the drug via inhalation, targeting lung cells and reducing systemic exposure. ARIKAYCE4 has already been tested in lung infections caused by related bacteria.
CONDITIONS
Brief Title
Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Use of highly effective or acceptable contraception
- Meet ATS/IDSA 2020 criteria for nontuberculous mycobacterial pulmonary infection
- Infection caused by Mycobacterium xenopi
You will not qualify if you...
- Known hypersensitivity to any study medication
- Relapse of Mycobacterium xenopi lung infection
- Use of medications interfering with cytochrome P450 that cannot be replaced
- HIV 1 or 2 infection
- Renal failure with creatinine clearance less than 30 mL/min
- Pregnancy or breastfeeding
- Cystic fibrosis
- Hypersensitivity to aminoglycosides, soy, or ARIKAYCE4 components
- Use of other aminoglycosides
- Severe renal failure
- Allergy to macrolides or clarithromycin excipients
- Use of medications interacting with clarithromycin causing serious risks
- Congenital or acquired prolonged QT interval or related heart rhythm disorders
- Electrolyte imbalances (low potassium or magnesium)
- Severe hepatic and renal insufficiency with clarithromycin
- Hypersensitivity to rifamycins or rifampicine excipients
- Porphyrias
- Use of specific interacting drugs with rifampicine
- Hypersensitivity to ethambutol
- Optic neuritis
- Wheat allergy (other than celiac disease)
- Substance abuse or inability to comply with protocol
- Limited life expectancy (e.g., less than 3 months)
- Hematologic malignancies or allogeneic hematopoietic stem cell transplant
- Women of childbearing age not using effective contraception
- Use of QT-prolonging drugs that cannot be replaced
- Heart failure with left ventricular ejection fraction less than 30%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months (duration determined with date of sputum conversion)
Participants receive treatment regimens containing rifampicin, ethambutol, and clarithromycin with or without ARIKAYCE® during the first 6 months of treatment.
Trial Site Locations
Total: 1 location
1
CHU Amiens-Picardie
Amiens, France, 80054
Actively Recruiting
Research Team
C
Claire ANDREJAK, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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