Liposomal Amikacin Inhalation in M.Abscessus Patients

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    400
  • sponsor
    University Hospital, Montpellier
Updated on 27 February 2022

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

Details
Condition M.Abscessus Pulmonary Disease
Clinical Study IdentifierNCT04163601
SponsorUniversity Hospital, Montpellier
Last Modified on27 February 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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