Comparing Clarithromycin and Azithromycin with Rifampicin and Ethambutol for Treating Mycobacterium Avium Complex Lung Infections Phase 3 Study on Treatment Effectiveness and Tolerance

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.

CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections