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

Study acronym: CLAZI
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Site details revised at 1 of 3 sitesv8
  2. Primary completion date: Feb 1, 2025 to Feb 5, 2028
    • Study sites: 2 to 3
    • Study completion date: Feb 1, 2025 to Feb 5, 2029
    v7
  3. Primary and study completion dates: Feb 1, 2023 to Feb 1, 2025v6
  4. 3 versions Re-verified since Jul 17, 2020, no change to tracked fieldsv3-v5
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Sep 20, 2017 to Feb 5, 2018
    • Study sites: 1 to 2
    • Primary and study completion dates: Sep 20, 2022 to Feb 1, 2023
    • Eligibility criteria expanded, about 13 words
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03236987
Lead Sponsor Centre Hospitalier Universitaire, Amiens
Conditions
(from sponsor)		 Lung Infection, MAC Lung Disease
Enrollment 424 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov