Clinical trials: Mycobacterium Abscessus Pulmonary Disease
Cystic Fibrosis
Study of a Nebulised Nitric Oxide Generating Solution in Patients With Mycobacterium Abscessus
To evaluate the change in M. abscessus cfu/g in induced sputum samples from baseline to the end of treatment with RESP301 in patients with cystic fibrosis who have treatment-naïve or treatment-refractory M.
- Trial name
- NOMAB (NCT05101915)
- Testing
- RESP301
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Papworth Hospital NHS Foundation Trust
Pulmonary Disease Due to Mycobacteria (Diagnosis)
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans.
- Trial name
- FORMaT (NCT04310930)
- Testing
- Amikacin, Tigecycline, Imipenem
- Where
- 50 sites in Australia, Denmark and 5 more
- Volunteers
- 300 people
- Sponsor
- The University of Queensland
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
Mycobacterium Abscessus Infection, Adult-Onset Immunodeficiency With Acquired Anti-Interferon-Gamma Autoantibodies
Treatment Outcome Between Mycobacterium Abscessus Infection in Chronic Lung Disease and Acquired Interferon-gamma Autoantibody Syndrome
The treatment outcome of Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome has not been well studied.
- Conditions
- Mycobacterium Abscessus Infection, Adult-Onset Immunodeficiency With Acquired Anti-Interferon-Gamma Autoantibodies, Nontuberculous Mycobacterial Pulmonary Infection
- Trial name
- NCT05354583
- Testing
- Appropriate treatment
- Where
- Thailand
- Volunteers
- 36 people
- Sponsor
- King Chulalongkorn Memorial Hospital
Mycobacterium Abscessus Infection
Epetraborole in Patients With Mycobacterium Abscessus Lung Disease
This double-blind, randomized, placebo-controlled, parallel-group, multicenter, prospective, investigator-initiated trial will evaluate epetraborole (EBO) monotherapy in the treatment of adults with Mycobacterium abscessus…
- Trial name
- REBOUND (NCT07301320)
- Testing
- Epetraborole
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Kevin Winthrop
Non-Tuberculous Mycobacterial Pneumonia, Cystic Fibrosis Lung
Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis
In this project the investigators aim to identify new biological markers by characterizing the response/inflammation associated with the development and progression of M.
- Trial name
- BioMol-MA (NCT06413459)
- Testing
- Luminex; scRNAsec
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Ospedale San Raffaele
Mycobacterium Infections, Nontuberculous, Cystic Fibrosis (CF)
Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection
A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis (CF) subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing…
- Trial name
- ENCORE (NCT03597347)
- Testing
- Molgramostim nebulizer solution, PARI eFlow nebulizer system
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Savara Inc.
Nontuberculous Mycobacterial Pulmonary Infection
PK and PD of Antibiotics for Treatment of Mycobacterium Abscessus Pulmonary Disease
Investigating the PK and PD indices in patients with M. abscessus complex-PD who will be treated with a currently recommended regimen, minimum inhibitory concentrations of organism, and their relation with clinical outcomes
- Trial name
- NCT05676138
- Testing
- Measuring PK and PD indices in patients who receive conventional treatment
- Volunteers
- 40 people
- Sponsor
- Seoul National University Hospital
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 Abscessus Lung Disease
The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance
Background: Mycobacterium abscessus, one of the most common species of nontuberculous mycobacterium (NTM), poses a significant clinical challenge due to its natural resistance to antibiotics and high treatment failure rates…
- Trial name
- NCT07514364
- Testing
- Rifabutin, No Rifabutin
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- National Taiwan University Hospital
Mycobacterium Abscessus Pulmonary Disease
TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease
Chinese herbs can facilitate sputum culture conversion, promote lesion absorption, and enhance clinical symptoms and quality of life for patients with Mycobacterium abscessus pulmonary disease (MAB-PD).
- Trial name
- NCT07295938
- Testing
- Chinese herbs-I, Chinese herbs-II
- Where
- 8 sites in China
- Volunteers
- 352 people
- Sponsor
- Shanghai University of Traditional Chinese Medicine
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
Nontuberculous Mycobacterium Infection, Mycobacterium Abscessus Infection
Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Abscessus Complex
The purpose of this study is to evaluate the efficacy and safety of delpazolid add-on therapy in Patients with Refractory Mycobacterium abscessus Complex Pulmonary disease
- Trial name
- NCT06004037
- Testing
- Delpazolid
- Where
- 5 sites in South Korea
- Volunteers
- 24 people
- Sponsor
- LigaChem Biosciences, Inc.
Non-Tuberculous Mycobacterial (NTM) Pneumonia, Mycobacterium Abscessus Infection
Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection
This study aims to use mycobacteriophage therapy, using identified in-vitro effective Mycobacteriophage Muddy_HRMN0052, along with combination conventional antimycobacterial therapy for their NTM pulmonary disease with…
- Trial name
- NCT07228702
- Testing
- Mycobacteriophage Muddy_HRMN0052, Amikacin Injection, Clofazimine
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- Vancouver Coastal Health
Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by…
- Conditions
- Mycobacterium Infections, Nontuberculous, Mycobacterium Abscessus Infection, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterial Pulmonary Infection
- Trial name
- NCT04922554
- Testing
- Omadacycline Oral Tablet
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- Paratek Pharmaceuticals Inc
Mycobacterium Abscessus Infection, Bacteriophage Therapy
Bacteriophage for Chronic Multidrug-Resistant Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection
The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant…
- Conditions
- Mycobacterium Abscessus Infection, Bacteriophage Therapy, Pulmonary Disease
- Trial name
- NCT07429162
- Testing
- DP-QB-MYA-002
- Volunteers
- 1 people
- Sponsor
- Alberta Health services
Mycobacterium Infections, Nontuberculous, Mycobacteria, Atypical
Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease
The proposed study will assess the efficacy, safety and tolerability of once daily dosing of Liposomal-Amikacin for Inhalation (LAI) 590 mg for 12 months plus standard of care (SOC) mycobacterial multi-drug regimen in accordance…
- Trial name
- NCT03038178
- Testing
- LAI plus multi-drug regimen
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Kevin Winthrop
Mycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection
Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial
The goal of this clinical trial is to learn if a new combination antibiotic treatment (Arm D) works to treat a rare lung condition called mycobacterium abscessus pulmonary disease in people of any age and sex, when compared to…
- Conditions
- Mycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection, Non-Tuberculous Mycobacterial (NTM) Infections, Non-Tuberculous Mycobacteria Pulmonary Disease
- Trial name
- FORMaT-EVOLVE (NCT07485010)
- Testing
- Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Ceftriaxone for Injection, Amoxicillin
- Volunteers
- 300 people
- Sponsor
- The University of Queensland
Cystic Fibrosis (CF), Mucoviscidosis
Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households
This multicenter, non-interventional case-control study investigates whether household environmental reservoirs, particularly water systems, are associated with non-tuberculous mycobacterial (NTM) infections in people with cystic…
- Conditions
- Cystic Fibrosis (CF), Mucoviscidosis, Non-Tuberculous Mycobacteria, Mycobacterium Abscessus Infection
- Trial name
- NTMecoCF (NCT07369414)
- Testing
- Multi-modal NTM diagnostic including PCR, WGS, culture
- Where
- 2 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Research Center Borstel
Mycobacterium Abscessus Infection, NTM Lung Infection Due to MAC
To Evaluate the Clinical Efficacy and Safety of Omadacycline in the Treatment of Mycobacterium Abscessus Infection.
The objective of this clinical trial is to evaluate the correlation between clinical efficacy and safety of omadacycline in the treatment of Mycobacterium abscessus infection through retrospective cohort studies.
- Trial name
- NTM (NCT07615309)
- Testing
- Omadacycline Treatment Group
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Beijing Chest Hospital