Mycobacterium Infections, Nontuberculous Clinical Trial
Official title:
An Open-label, Non-controlled, Multicentre, Pilot Clinical Trial of Inhaled Molgramostim in Subjects With Antibiotic-resistant Non-tuberculosis Mycobacterial (NTM) Infection
The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor; rhGM-CSF) in subjects with persistent pulmonary Nontuberculous Mycobacterial (NTM) infection. Subject will be treated for 24-weeks with inhaled molgramostim and will be followed up for 12-weeks after end of treatment. The primary aim of the trial is to investigate the efficacy of inhaled molgramostim on NTM sputum culture conversion to negative.
The study will comprise a Screening Visit, Baseline Visit, a 24-week treatment period and a 12-week follow up period. The Screening Visit (Visit 1) will be conducted up to 10 weeks prior to the Baseline Visit (Visit 2) to determine eligibility. Adult subjects with a history of chronic Nontuberculous Mycobacterial (NTM) infection with at least 2 positive cultures in the prior two years, of which at least one is within the last 6 months prior to Screening, will be considered for enrollment. Subjects should provide a positive NTM sputum culture at Screening to be eligible. Two subgroups of subjects will be recruited: - Group 1: Subjects who remain sputum culture positive while currently on a multidrug NTM guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit. - Group 2: Subjects who remain sputum culture positive but have either stopped a multidrug NTM guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or never started such treatment. The study will include 30 subjects. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03038178 -
Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease
|
Phase 2 | |
| Active, not recruiting |
NCT04922554 -
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
|
Phase 2 | |
| Terminated |
NCT04154826 -
Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease
|
Phase 2 | |
| Completed |
NCT02344004 -
Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
|
Phase 3 | |
| Recruiting |
NCT06266442 -
M. Avium WGS During Mav-PD Treatment
|
||
| Recruiting |
NCT02355015 -
A Prospective Registry For Non Tuberculous Mycobacterial (NTM) Infections
|
N/A | |
| Not yet recruiting |
NCT06418711 -
ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension
|
Phase 3 | |
| Terminated |
NCT03597347 -
Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection
|
Phase 2 | |
| Completed |
NCT02832843 -
Genome-Wide Association Study in Patients With Nontuberculous Mycobacterial Lung Disease
|
||
| Completed |
NCT04677543 -
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
|
Phase 3 | |
| Completed |
NCT02340897 -
Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT
|
N/A | |
| Completed |
NCT01315236 -
Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria
|
Phase 2 | |
| Recruiting |
NCT04677569 -
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
|
Phase 3 |