An Extension Study Assessing the Long-Term Safety, Tolerability, and Effectiveness of Liposomal Amikacin Inhalant in Patients with Non-Tuberculous Mycobacterial Lung Infections, Who Participated in Study INS-212

Overview

About this study

The purpose of this extension study is to assess the safety, tolerability, and effectiveness of Liposomal Amikacin for Inhalation added to a multi-drug regimen in subjects with non-tuberculous mycobacterium lung infections due to Mycobacterium avium complex who were resistant to therapy in Study INS-212.

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

  • Have successfully completed the month 6 and end of treatment visits in Study INS-212
  • Have not achieved the INS-212 protocol definition of culture conversion by month 6 in Study INS-212
  • OR have experienced a relapse or recurrence by month 6 in Study INS-212

Exclusion Criteria

  • Achieved culture conversion without relapse or recurrence in Study INS-212  by month 6

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
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