CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections
Recruiting
Phase 3
Interventional Study
Lung Infection
MAC Lung Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 424 (estimated)
- Sponsor
- Centre Hospitalier Universitaire, Amiens · Other
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About This Trial
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 fou…
Trial Locations
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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 excl…
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