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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

January 9, 2015
January 22, 2015
March 23, 2018
May 27, 2015
May 1, 2019   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02344004 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mycobacterium Infections, Nontuberculous
Drug: Liposomal Amikacin for Inhalation
  • 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)
    Intervention: Drug: Liposomal Amikacin for Inhalation
Griffith DE, Eagle G, Thomson R, Aksamit TR, Hasegawa N, Morimoto K, Addrizzo-Harris DJ, O'Donnell AE, Marras TK, Flume PA, Loebinger MR, Morgan L, Codecasa LR, Hill AT, Ruoss SJ, Yim JJ, Ringshausen FC, Field SK, Philley JV, Wallace RJ Jr, van Ingen J, Coulter C, Nezamis J, Winthrop KL; CONVERT Study Group. Amikacin Liposome Inhalation Suspension for Treatment-Refractory Lung Disease Caused by Mycobacterium avium Complex (CONVERT): A Prospective, Open-Label, Randomized Study. Am J Respir Crit Care Med. 2018 Sep 14. doi: 10.1164/rccm.201807-1318OC. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
350
Same as current
July 2019
May 1, 2019   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Canada,   France,   Germany,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Spain,   Sweden,   Taiwan,   Thailand,   United Kingdom,   United States
 
 
NCT02344004
INS-212
2014-005010-31 ( EudraCT Number )
Yes
Not Provided
Not Provided
Insmed Incorporated
Insmed Incorporated
Not Provided
Study Director: Gina Eagle, MD Insmed Incorporated
Insmed Incorporated
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP