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

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ClinicalTrials.gov Identifier: NCT02344004
Recruitment Status : Active, not recruiting
First Posted : January 22, 2015
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Insmed Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Mycobacterium Infections, Nontuberculous Drug: Liposomal Amikacin for Inhalation Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
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
Actual Study Start Date : May 27, 2015
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

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 147 Study Locations
Sponsors and Collaborators
Insmed Incorporated
Investigators
Study Director: Gina Eagle, MD Insmed Incorporated

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Insmed Incorporated
ClinicalTrials.gov Identifier: NCT02344004     History of Changes
Other Study ID Numbers: INS-212
2014-005010-31 ( EudraCT Number )
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

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