Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone

Overview

About this study

A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) when added to multi-drug regimen in subjects with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Be continually positive for MAC on sputum culture while adhering to a multi-drug treatment regimen for a minimum duration of 6 months which is either ongoing or was completed no more than 12 months before screening
  2. Be diagnosed with MAC NTM lung infection with evidence of nodular bronchiectasis and/or fibrocavitary disease by chest CT
  3. Be willing to adhere to multi-drug treatment regimen during the course of the study

Exclusion Criteria:

  1. Patients with cystic fibrosis
  2. Positive pregnancy test or lactation at screening. All women of child bearing potential will be tested. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrheic for at least 1 year), or surgically or naturally sterile.
  3. Active pulmonary tuberculosis requiring treatment at screening
  4. History of lung transplantation
  5. Prior exposure to LAI (including clinical study).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Aksamit, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20147219

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