Liposomal Amikacin Inhalation in M.Abscessus Patients

NCT ID: NCT04163601

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-30

Study Completion Date

2024-03-31

Brief Summary

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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

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Conditions

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M.Abscessus Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European network (http://www.ntm-net.org/index.php/ntm-net)

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphael CHIRON, PU-PH

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Montpellier

Locations

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Uh Montpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Raphael CHIRON, PU-PH

Role: CONTACT

467336089 ext. 33

Facility Contacts

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RAPHAEL CHIRON, PU-PH

Role: primary

467336089 ext. 33

Other Identifiers

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RECHMPL19_0487

Identifier Type: -

Identifier Source: org_study_id

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