Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection
Recruiting
Phase 2
Interventional Study
Mycobacterium; Xenopi
Lung Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 190 (estimated)
- Sponsor
- Centre Hospitalier Universitaire, Amiens · Other
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About This Trial
Treatment of Mycobacterium xenopi (MX) lung disease is not-well- tolerated and concerned a growing number of patients, especially with chronic pulmonary diseases or immunosuppression. The outcome of these patients is poor, and treatment is very long. Indeed, this duration is based on the date of sputum conversion. Treatment should be continued until 12 months after sputum conversion. In the vast m…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 18 years old or older
* with an highly effective or acceptable contraception
* must present ATS/IDSA 2020 criteria for nontuberculous mycobacterial pulmonary infection
* the NTM should be M. xenopi
Exclusion Criteria:
* Patients presenting any of the following criteria canno…
Contacts