Actively Recruiting
CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-19
424
Participants Needed
3
Research Sites
574 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
MAC lung infections are a growing public health problem. The ATS / IDSA 2007 guidelines for the treatment of these non-tuberculous mycobacterial infections recommend the use of a macrolide or azalide (clarithromycin or azithromycin), rifampicin or rifabutin and ethambutol. For MAC disseminated infections, several studies have compared combinations containing clarithromycin or azithromycin and found no significant difference in efficacy. No randomized controlled trials have been performed for pulmonary infections to compare clarithromycin and azithromycin in terms of efficacy. Clarithromycin is often used as a first-line treatment in France, but its tolerance is often poor, particularly in terms of risk of hepatitis, metallic taste in the mouth, nausea or vomiting, and it interacts with many drugs via cytochrome p450 . In particular, it increases the toxicity of rifabutin, in particular in terms of uveitis. Azithromycin has fewer side effects especially less digestive toxicity and drug interactions than clarithromycin. The hypothesis is therefore that the efficacy of azithromycin would be non-inferior in comparison with that of clarithromycin.
CONDITIONS
Official Title
CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Positive Mycobacterium avium complex sample showing ATS/IDSA infection criteria requiring treatment
- Meeting ATS/IDSA clinico-radiological and microbiological criteria for infection
- Exclusion of other diagnoses based on thoracic CT, fibroscopy, and bacteriological samples
You will not qualify if you...
- Known hypersensitivity to rifampicin, ethambutol, azithromycin, or clarithromycin
- Relapse of an MAC infection
- Strain resistant to macrolides based on genotyping susceptibility testing performed before inclusion
- Treatment interacting with cytochrome p450 that cannot be replaced
- HIV serology positive for type 1 or 2
- Renal insufficiency with creatinine clearance less than 30 ml/min
- Pregnancy or breastfeeding
- Contraindication to any of the antibiotics
- Inability to follow the protocol due to drug addiction or other reasons
- Limited life expectancy less than 6 months
- Participation in another clinical trial for non-tuberculous mycobacteria treatment or strategy
AI-Screening
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Trial Site Locations
Total: 3 locations
1
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Not Yet Recruiting
2
CHU Angers
Angers, France, 49933
Actively Recruiting
3
Saint Joseph Hospital
Marseille, France, 13000
Actively Recruiting
Research Team
C
Claire ANDREJAK, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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