Comparing Clarithromycin and Azithromycin for MAC Lung Infections

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

This study is testing whether clarithromycin or azithromycin works better and is safer for people with lung infections caused by Mycobacterium avium complex.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire, Amiens (Academic / other)
• Locations: 3 sites (Amiens, Picardie and 2 other locations)
• Trial ID: NCT03236987 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the efficacy and safety of clarithromycin and azithromycin in treating lung infections caused by Mycobacterium avium complex (MAC). It focuses on patients who meet specific clinical, radiological, and microbiological criteria for MAC infection. The study will involve administering either clarithromycin or azithromycin alongside rifampicin and ethambutol to evaluate which treatment is more effective and better tolerated. The trial is significant as it addresses a gap in existing research regarding the treatment of pulmonary MAC infections.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of MAC lung infection requiring treatment.

Not a fit: Patients with known hypersensitivity to the study medications, those with resistant strains of MAC, or individuals with certain health conditions such as severe renal insufficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from MAC lung infections, potentially reducing side effects and enhancing efficacy.

How similar studies have performed: While previous studies have compared macrolides for MAC infections, this trial is novel as it specifically focuses on pulmonary infections and has not been previously conducted.

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.

Where this trial is running

Amiens, Picardie and 2 other locations

• CHU Amiens Picardie — Amiens, Picardie, France (Not_yet_recruiting)
• CHU Angers — Angers, France (Recruiting)
• Saint Joseph Hospital — Marseille, France (Recruiting)

Study contacts

• Study coordinator: Claire ANDREJAK, PhD

Conditions Lung Infection; MAC Lung Disease; Clarithromycin; Azithromycin; Efficacy; Safety