Liposomal Amikacin Inhalation in M.Abscessus Patients

• Conditions: M.Abscessus Pulmonary Disease

• Registration Number: NCT04163601
• Lead Sponsor: University Hospital, Montpellier

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Study Start: 2019-11-30
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12
• Primary Completion: 2020-12-01
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France