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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:
ClinicalTrials.gov Identifier:
NCT02344004
First Posted: January 22, 2015
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Insmed Incorporated
  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: None (Open Label)
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:


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

Information from the National Library of Medicine

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

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Submitted: January 9, 2015
First Posted: January 22, 2015
Last Update Posted: February 7, 2017
Last Verified: February 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