M.Abscessus Pulmonary Disease
Conditions
Brief summary
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
Interventions
None listed
Sponsors
European network (http://www.ntm-net.org/index.php/ntm-net)
University Hospital, Montpellier
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| culture conversion | 1 day | Main study endpoints will consist of microbiological cure, clinical cure and treatment culture conversion at the end of treatment. Treatment outcome definitions according to the NTM net consensus are used |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical cure | 1 day | Main study endpoints will consist of microbiological cure, clinical cure and treatment culture conversion at the end of treatment. Treatment outcome definitions according to the NTM net consensus are used |
Countries
France
Contacts
Primary ContactRaphael CHIRON, PU-PH
Outcome results
None listed