NTM Lung Infection Due to MAC Clinical Trial
Official title:
An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients With Nontuberculous Mycobacterial (NTM) Lung Infections Caused by Mycobacterium Avium Complex (MAC) That Are Refractory to Treatment
This is an open-label safety extension study to assess the safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in participants with nontuberculous mycobacterial (NTM) lung infections due to Mycobacterium avium complex (MAC) who were refractory to therapy and failed to convert in Study INS-212 (NCT02344004).
Safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation
(LAI) added to a multi-drug regimen in participants with non-tuberculous mycobacterium (NTM)
lung infections due to Mycobacterium avium complex (MAC) who are refractory to therapy and
failed to convert in Study INS-212.
Participants participating in Study INS-212 who had not achieved the INS-212 protocol
definition of culture conversion (3 consecutive monthly negative sputum cultures) or who had
experienced a relapse or recurrence (agar positive or more than 2 consecutive broth positive
results after culture conversion had occurred) by Month 6, as determined by their sputum
culture results from Day 1 through Month 6 and confirmed at their scheduled Month 8 visit,
were eligible to participate in Study INS-312. For participants who chose to participate in
Study INS-312, the Month 8 visit of Study INS-212 became their end of treatment (EOT) visit;
these participants were then asked to provide written informed consent for Study INS-312 and
were enrolled directly into Study INS-312 after having met all eligibility criteria.
Participants in Study INS-212 had either received 590 mg LAI plus an MDR (LAI + MDR arm) or a
multidrug regimen alone (MDR alone arm). All participants in this safety extension study were
to continue the multidrug antimycobacterial regimen that they were receiving during Study
INS-212 and will receive LAI 590 mg administered daily (QD) for up to 12 months. The
participants will remain in the study for up to a total of 13 months (up to 12 months
on-treatment plus 1 month off LAI treatment for safety follow up).
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