Informations générales (source: ClinicalTrials.gov)
CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections (CLAZI)
Interventional
Phase 3
Centre Hospitalier Universitaire, Amiens (Voir sur ClinicalTrials)
février 2018
février 2029
03 avril 2025
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.
Etablissements
Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
CHI DE CRETEIL | Bernard MAITRE | 29/03/2024 01:28:04 | Contacter | ||
HOPITAL FOCH | EMILIE CATHERINOT | 07/04/2025 07:02:08 | Contacter | ||
HOPITAL NOVO | GOSSET-WOIMANT Marine | 14/02/2025 09:03:14 | Contacter | ||
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
CHU Amiens Picardie - 80054 - Amiens - Picardie - France | Claire ANDREJAK, PhD | Contact (sur clinicalTrials) | |||
CHU Angers - 49933 - Angers - France | Contact (sur clinicalTrials) | ||||
Saint Joseph Hospital - 13000 - Marseille - France | Audoly Cristina, PH | Contact (sur clinicalTrials) |
Critères
Tous
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
- 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
- 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.