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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Insmed Incorporated

ClinicalTrials.gov Identifier:

NCT02344004

First received: January 9, 2015

Last updated: February 3, 2017

Last verified: February 2017

History of Changes

Purpose

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).

Condition	Intervention	Phase
Mycobacterium Infections, Nontuberculous	Drug: Liposomal Amikacin for Inhalation	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	A Randomized, Open-label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients With Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC) That Are Refractory to Treatment

Resource links provided by NLM:

MedlinePlus related topics: Mycobacterial Infections

Drug Information available for: Amikacin sulfate

Genetic and Rare Diseases Information Center resources: Mycobacterium Avium Complex

U.S. FDA Resources

Further study details as provided by Insmed Incorporated:

Primary Outcome Measures:

Proportion of patients achieving culture conversion in the LAI plus a multi-drug regimen arm compared to a multi-drug regimen alone with no relapse or recurrence [ Time Frame: by 6 months ]

Secondary Outcome Measures:

Change from baseline in 6 Minute Walk Test (MWT) distance in the LAI plus a multi-drug regimen compared to a multi-drug regimen alone [ Time Frame: 6 months and up to 16 months ]


Estimated Enrollment:	350
Actual Study Start Date:	January 2015
Estimated Study Completion Date:	July 2019
Estimated Primary Completion Date:	October 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Multi-drug regimen Patients will receive their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines)
Experimental: Multi-drug regimen + LAI Subjects will receive LAI in addition to their already prescribed anti-mycobacterial regimen (based on the 2007 ATS/IDSA Guidelines)	Drug: Liposomal Amikacin for Inhalation

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
Be diagnosed with MAC NTM lung infection with evidence of nodular bronchiectasis and/or fibrocavitary disease by chest CT
Be willing to adhere to multi-drug treatment regimen during the course of the study

Exclusion Criteria:

Patients with cystic fibrosis
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.
Active pulmonary tuberculosis requiring treatment at screening
History of lung transplantation
Prior exposure to LAI (including clinical study).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02344004

Show 149 Study Locations

Sponsors and Collaborators

Insmed Incorporated

Investigators


Study Director:	Gina Eagle, MD	Insmed Incorporated

More Information


Responsible Party:	Insmed Incorporated
ClinicalTrials.gov Identifier:	NCT02344004 History of Changes
Other Study ID Numbers:	INS-212 2014-005010-31 ( EudraCT Number )
Study First Received:	January 9, 2015
Last Updated:	February 3, 2017

Additional relevant MeSH terms:


Infection Mycobacterium Infections Mycobacterium Infections, Nontuberculous Actinomycetales Infections Gram-Positive Bacterial Infections	Bacterial Infections Amikacin Anti-Bacterial Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on July 17, 2017

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