Liposomal Amikacin Inhalation in M.Abscessus Patients

NTM-net Study: Liposomal Amikacin Inhalation in M.Abscessus Patients

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

Study Overview

• Status: Recruiting
• Conditions: M.Abscessus Pulmonary Disease

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: RAPHAEL CHIRON, PU-PH; Phone Number: 33 467336089; Email: c-chiron@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • UH Montpellier
    • Contact: RAPHAEL CHIRON, PU-PH; Phone Number: 33 467336089; Email: c-chiron@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with M. abscessus disease

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
culture conversion	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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical cure	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	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: European network (http://www.ntm-net.org/index.php/ntm-net)

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): March 31, 2024

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (ACTUAL): November 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: RECHMPL19_0487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No