Liposomal Amikacin Inhalation in M.Abscessus Patients

University Hospital Center (CHU)

Status: Unknown

Conditions: M.Abscessus Pulmonary Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04163601

RECHMPL19_0487

Details and patient eligibility

About

Mycobacterium abscessus is one of the many species of non-tuberculous mycobacteria. M. abscessus infections are known to be common in patients with cystic fibrosis (CF). Mycobacterium abscessus yields poor cure rates. Liposomal amikacin inhalation (LAI) might be a good alternative for intravenous treatment as the first results with mycobacterium avium treatment yield good results.

The objective of this study is to summarize the clinical data of patients with M.abscessus treated with LAI on compassionate use basis to assess treatment outcomes

Enrollment: 400 estimated patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• ATS diagnostic criteria for M.abscessus pulmonary disease
• > 12 years
• Patients with CF/COPD or other underlying disease
• LAI use for more than 3 weeks

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Extra-pulmonary or disseminated disease