Actively Recruiting
Clarithromycin Versus Azithromycin in Treating Mycobacterium Avium Complex Lung Infections
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-19
424
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for Mycobacterium avium complex (MAC) lung infections, a growing public health concern caused by non-tuberculous mycobacteria. This trial compares two antibiotic regimens to evaluate whether azithromycin is not less effective than clarithromycin when combined with rifampicin and ethambutol, aiming to improve tolerance and treatment adherence in adult patients with fibrocavitary or nodular bronchiectatic forms of MAC lung disease. Participants will be randomly assigned to receive one of two treatment combinations: rifampicin, ethambutol, and clarithromycin (1000 mg daily in two doses), or rifampicin, ethambutol, and azithromycin (250 mg once daily). Treatment is administered daily for at least 12 months. The study is open-label and conducted across multiple centers in France, with medication compliance monitored through patient records. During the 12-month treatment period, participants will undergo regular monitoring including liver function tests, blood counts, monthly eye exams, and electrocardiograms. Pharmacokinetic studies will measure antibiotic levels in blood and cells at 1 and 6 months. Clinical, radiological, and microbiological assessments occur at baseline, 3, 6, and 12 months. Long-term follow-up up to 5 years will track adverse effects, relapses, and survival. The main outcome measured is sputum culture results at 6 months.
CONDITIONS
Brief 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
- Confirmed Mycobacterium avium complex infection meeting ATS/IDSA clinical, radiological, and microbiological criteria
- Infection requires treatment
- Exclusion of other diagnoses by thoracic CT, fibroscopy, and bacteriological samples
You will not qualify if you...
- Known allergy to rifampicin, ethambutol, azithromycin, or clarithromycin
- Relapse of a MAC infection
- Macrolide-resistant strain based on genotyping before inclusion
- Use of treatments interacting with cytochrome p450 that cannot be replaced
- HIV positive serology
- Renal insufficiency with creatinine clearance under 30 ml/min
- Pregnancy or breastfeeding
- Contraindication to study antibiotics
- Inability to follow protocol due to drug addiction
- Life expectancy less than 6 months
- Current participation in another clinical trial for non-tuberculous mycobacteria
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 12 months
Participants receive a combination of three antibiotics (rifampicin, ethambutol, and either clarithromycin or azithromycin) daily for at least 12 months to treat Mycobacterium avium complex lung infections. Treatment includes regular monitoring of clinical status, liver function, blood counts, and eye health.
Weekly visits for the first 2 weeks, then monthly visits during treatment
Duration - Up to 5 years after treatment
Participants are monitored for new adverse effects, relapse, and survival after treatment ends, with assessments continuing up to 5 years when possible.
Visits at 18, 24, 36 months, and possibly at 5 years post-treatment
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
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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