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

NCT03236987 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire, Amiens

Phase

Phase 3

Started

2018-02-05

Last updated

2025-11-19

Condition(s) studied

Lung InfectionMAC Lung Disease

Investigational drug(s) / intervention(s)

Clarithromycin 1000 MG →Azithromycin 250 mg →Rifampicin →Ethambutol →

Clarithromycin 1000 MG: The patient will be received for at least 12 months, a daily antibiotic treatment who is a combination of Clarithromycin, Ethambutol and Rifampicin.

Azithromycin 250 mg: The patient will be received for at least 12 months, a daily antibiotic treatment who is a combination of Azithromycin, Ethambutol and Rifampicin.

Rifampicin: The patient will be received for at least 12 months, a dailty antibiotic treatment who is a combination of Azithromycin or Clarithromycin (according to the randomisation), Ethambutol and Rifampicin.

Ethambutol: The patient will be received for at least 12 months, a dailty antibiotic treatment who is a combination of Azithromycin or Clarithromycin (according to the randomisation), Ethambutol and Rifampicin.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Culture results of respiratory specimens taken 6 months after starting treatment. — 6 months
Three spontaneous sputum specimens will be obtained at baseline and 6 months. If it's not possible to obtain good quality specimens, the clinician may perform three hypertonic aerosol-induced sputum specimens on 3 consecutive days. In the absence of sputum (spontaneous or induced), bronchoscopic aspiration and two post-bronchoscopy sputum specimens will be performed. Microscopic examination will be performed after auramine or Ziehl-Neelsen stain. Specimens will be cultured at 37°C after decontamination on Lowenstein-Jensen solid medium and Coletsos medium. Results will be expressed quantitatively as the number of colonies per tube according to a logarithmic scale. Culture on liquid medium will also be performed. The analysis will be based on the Mycobacteria National Reference Centre microscopy, culture and antibiotic susceptibility test results.

Trial sites (3)

Facility	City	Region	Status
CHU Amiens Picardie	Amiens	Picardie	Not Yet Recruiting
CHU Angers	Angers	France	Recruiting
Saint Joseph Hospital	Marseille	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03236987 on ClinicalTrials.gov ↗ ← All trials in France