Status:
RECRUITING
CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Conditions:
Lung Infection
MAC Lung Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
1. Scientific rationale and general description: Nontuberculous mycobacteria (NTM) represent all mycobacteria not belonging to the Mycobacterium tuberculosis complex. This group of mycobacteria wa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 5 2029
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT03236987
Start Date
February 5 2018
End Date
February 5 2029
Last Update
November 19 2025
Active Locations (3)
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1
CHU Amiens Picardie
Amiens, Picardie, France, 80054
2
CHU Angers
Angers, France, 49933
3
Saint Joseph Hospital
Marseille, France, 13000