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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Aug 1, 2017

Keywords

ClinConnect Summary

This clinical trial is comparing two antibiotics, clarithromycin and azithromycin, to see which one works better for treating lung infections caused by a type of bacteria called Mycobacterium avium complex (MAC). MAC lung infections are becoming more common and can be serious, so finding the most effective treatment is important. Both medications are recommended in treatment guidelines, but this study aims to find out if azithromycin is just as effective as clarithromycin while potentially causing fewer side effects.

To participate in this trial, individuals must be at least 18 years old and have a confirmed MAC lung infection as determined by specific medical criteria. However, certain people will not be eligible, such as those with severe allergies to the study drugs, those with kidney problems, or those who are pregnant or breastfeeding. Participants can expect to receive either azithromycin or clarithromycin and will be closely monitored for their health and any side effects during the study. This research is important for improving treatment options for patients with MAC lung infections and ensuring they have a safer and more effective choice of medication.

Gender

ALL

Eligibility 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.