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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Azithromycin; Clarithromycin; Ethambutol; Rifampin

Criteria

Inclusion Criteria:

• patients 18 years of age or older

• having a positive Mycobacterium avium complex sample showing the ATS / IDSA infection criteria and requiring treatment

• ATS / IDSA infection criteria combine clinico-radiological criteria, associated with microbiological criteria

• the exclusion of any other diagnosis on the thoracic CT, fibroscopy and bacteriological samples

Exclusion Criteria:

• Known hypersensitivity to one of the study molecules (rifampicin, ethambutol, azithromycin, clarithromycin)

• Relapse of an MAC infection,

• Strain resistant to macrolides, based on genotyping susceptibility testing (genotyping susceptibility testing must be done before inclusion)

• Treatment that interacts with cytochrome p450 that can not be replaced by another therapeutic,

• HIV serology 1 and 2,

• Renal insufficiency with creatinine clearance less than 30 ml / min,

• Pregnancy and breast feeding,

• Contra-indication to one of the antibiotics,

• Impossibility to follow the protocol due in particular to drug addiction according to the investigator,

• Limited life expectancy, less than 6 months,

• Patient already participating in a clinical trial on a medical treatment or a therapeutic strategy for non-tuberculous mycobacteria.