Clinical trials: Mycobacterium Avium-intracellulare Infection
Mycobacterium Infections
Study of Mycobacterial Infections
This study will examine the symptoms, course of disease and treatment of non-tuberculous mycobacterial (NTM) infections, as well as the genetics involved in these infections.
- Trial name
- NCT00018044
- Testing
- Clofazimine
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Nontuberculous Mycobacterial Lung Disease, Mycobacterium Avium Complex
Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
The SALINE trial will investigate the effect of Hypertonic Saline inhalation plus best supportive care on burden of symptoms, clearance of mycobacteria and functional capacities in participants with Mycobacterium avium complex…
- Trial name
- SALINE (NCT05192057)
- Testing
- Hypertonic Saline inhalation
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Radboud University Medical Center
Mycobacterium Avium Complex
A Study of Standard Drugs for Mycobacterium Avium Complex
To assess the early bactericidal activity of Azithromycin 250mg by mouth daily over the first 14 days of treatment for Mycobacterium avium complex (MAC) lung disease.
- Trial name
- NCT04287049
- Testing
- Azithromycin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University
Nontuberculous Mycobacterial Lung Disease, Bronchiectasis
Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease
This multicenter randomized controlled trial evaluates the clinical and microbiological effects of inhaled 3% hypertonic saline in treatment-naïve patients with nontuberculous mycobacterial lung disease (NTM-LD).
- Trial name
- HiNTM (NCT07647575)
- Testing
- Nebulized 3% Hypertonic Saline, Nebulized Normal Saline
- Where
- Taiwan
- Volunteers
- 262 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan
MAC Lung Disease, Treatment Refractory MAC Lung Disease
Study of Epetraborole in Patients With Treatment-refractory MAC Lung Disease
This is a pivotal Phase 2/3, double-blind, placebo-controlled study of epetraborole + OBR (Optimized Background Regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease.
- Trial name
- NCT05327803
- Testing
- Epetraborole
- Where
- 91 sites in United States, Australia and 2 more
- Volunteers
- 177 people
- Sponsor
- AN2 Therapeutics, Inc
Mycobacterium Avium-intracellulare Infection, Mycobacterium Infections, Nontuberculous
Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)
The purpose of this study is to find out if the Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine can be used safely to treat Mycobacterium avium complex (MAC) lung disease.
- Trial name
- BOOST (NCT07094711)
- Testing
- Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine, preservative-free saline
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Virginia
Mycobacterium Avium Complex
Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)
The purpose of this study is to evaluate the clinical effectiveness and safety of clofazimine when used to treat Mycobacteria avium complex (MAC) lung disease. Funding Source - FDA OOPD
- Trial name
- NCT02968212
- Testing
- Clofazimine, sugar pill
- Where
- 6 sites in United States
- Volunteers
- 102 people
- Sponsor
- Oregon Health and Science University
Mycobacterium Infections, Nontuberculous
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background…
- Trial name
- ENCORE (NCT04677569)
- Testing
- ALIS, Azithromycin, Ethambutol
- Where
- 258 sites in United States, Argentina and 21 more
- Volunteers
- 425 people
- Sponsor
- Insmed Incorporated
Mycobacterium Avium Complex, Nontuberculous Mycobacterium Infection
Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated patients frequently experience debilitating side effects, and many patients delay the start of antibiotic treatment due to these risks.
- Trial name
- MAC2v3 (NCT03672630)
- Testing
- Azithromycin, Ethambutol, Rifampin
- Where
- 26 sites in United States, Canada
- Volunteers
- 474 people
- Sponsor
- Kevin Winthrop
Nontuberculous Mycobacterial Lung Disease, Mycobacterium Avium Complex (MAC)
Clinical Characteristics and Immune Escape Mechanism of Nontuberculous Mycobacterial Lung Disease in South China
Nontuberculous Mycobacterial lung disease (NTM-LD) is a significant infectious challenge. The precise causes remain unclear, diagnosis can be complex, treatment outcomes are often unsatisfactory, and the disease can severely…
- Trial name
- NTM-LD (NCT07377864)
- Testing
- Prospective Biospecimen Sub-cohort
- Volunteers
- 1,500 people
- Sponsor
- Eighth Affiliated Hospital, Sun Yat-sen University
Retrograde Intrarenal Surgery (RIRS), Urolithiasis
Evaluation of Sevoflurane Consumption During Initial Phase of Minimal-Flow Anesthesia in Retrograde Intrarenal Surgery
This study aimed to compare the effects of minimal-flow (0.5 L/min) and low-flow (1.0 L/min) sevoflurane anesthesia on agent consumption, anesthetic depth, and cardiorespiratory safety during retrograde intrarenal surgery (RIRS).
- Conditions
- Retrograde Intrarenal Surgery (RIRS), Urolithiasis, Minimal-flow Anesthesia, Sevoflurane
- Trial name
- SEVOMIN-RIRS (NCT07248917)
- Testing
- Sevoflurane Anesthesia with Minimal-flow, Sevoflurane Anesthesia with Low-flow
- Where
- Turkey (Türkiye)
- Volunteers
- 62 people
- Sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
MAC Lung Disease, Treatment Refractory MAC Lung Disease
ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)
- Conditions
- MAC Lung Disease, Treatment Refractory MAC Lung Disease, Mycobacterium Infections, Nontuberculous
- Trial name
- ICoN-1 (NCT06418711)
- Testing
- Clofazimine Inhalation Suspension
- Where
- 99 sites in United States, Australia and 3 more
- Volunteers
- 132 people
- Sponsor
- Mannkind Corporation
Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia
Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine
The purpose of this study is to evaluate the safety of progressively substituting day +3 and +4 post-transplant cyclophosphamide (PT-CY) with post-transplant bendamustine (PT-BEN) in myeloablative (MAC) haploidentical…
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndromes, Chronic Myelogenous Leukemia
- Trial name
- NCT02996773
- Testing
- Bendamustine, Cyclophosphamide
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Arizona
Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease
The purpose of the study is to evaluate 1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). 2.
- Trial name
- NCT05496374
- Testing
- SPR720 500 mg, SPR720 1000 mg
- Where
- 28 sites in United States
- Volunteers
- 25 people
- Sponsor
- Spero Therapeutics
Nontuberculous Mycobacterium Infection
IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
The purpose of this study is to assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM. Funding Source - FDA Office of Orphan Products Development (OOPD)
- Trial name
- ABATE (NCT04294043)
- Testing
- Gallium nitrate
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Chris Goss
Mycobacterium Infections, Nontuberculous
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the…
- Trial name
- ARISE (NCT04677543)
- Testing
- ALIS, Azithromycin, Ethambutol
- Where
- 62 sites in United States, Argentina and 10 more
- Volunteers
- 99 people
- Sponsor
- Insmed Incorporated
Mycobacterium Avium, Mycobacterium Infections, Nontuberculous
M. Avium WGS During Mav-PD Treatment
This is a prospective observational study using whole genome sequencing (WGS) to investigate whether new strains (other than the initially identified strain(s)) of M.
- Conditions
- Mycobacterium Avium, Mycobacterium Infections, Nontuberculous, Mycobacterium Infections, Nontuberculous Mycobacterial Lung Disease
- Trial name
- NCT06266442
- Testing
- Whole genome sequencing testing
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University Health Network, Toronto
Mycobacterium Avium Complex, Mycobacterium Avium-Intracellulare Infection
Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease
The incidence and prevalence of nontuberculous mycobacteria (NTM) infections have gradually increased over the years worldwide (1-3).
- Conditions
- Mycobacterium Avium Complex, Mycobacterium Avium-Intracellulare Infection, Gram-Positive Bacterial Infections, Mycobacterium Infections
- Trial name
- NCT05824988
- Testing
- Drug exposure
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis, Mycobacterial Pneumonia, Mycobacterium Abscessus Infection
- Trial name
- NCT04685720
- Testing
- LungFit
- Where
- Australia
- Volunteers
- 15 people
- Sponsor
- Beyond Air Inc.
Mycobacterium Avium Complex, Non-tuberculous Mycobacterium Pulmonary Disease
Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)
- Trial name
- NCT04553406
- Testing
- SPR720, Open-label Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 2 people
- Sponsor
- Spero Therapeutics