Clinical Research Directory

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 the standard treatments. It will also learn about the safety of this new combination antibiotic treatment when compared to the standard treatments. The main questions it aims to answer are: * How well does Arm D treat mycobacterium abscessus pulmonary disease? * What side effects does Arm D cause when used to treat mycobacterium abscessus pulmonary disease? Researchers will compare Arm D to the current standard of care treatments to see if Arm D treats mycobacterium abscessus pulmonary disease better and if it will cause less side effects. Participants will: * Be screened and recruited to the FORMaT adaptive platform trial (NCT04310930) * Be given Arm D for 4 weeks or standard of care treatments for 6 weeks. * Be reviewed by the study doctors weekly for checkups and tests. * Provide respiratory samples (sample coughed up from the chest), respond to quality-of-life questionnaires, have CT lung scans and blood tests.

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 Mycobacterium abscessus pulmonary disease, with the goal of reducing mycobacterial burden and improving pulmonary outcomes.

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 complex (MABc) Lung Disease (LD) of mild to moderate severity. For this study, two EBO oral dose regimens will be studied in patients with MABc-LD, each compared to a placebo group (ie, 4 treatment groups): 500 mg daily and 750 mg daily. Detailed inclusion and exclusion criteria attempt to identify only those patients who have acceptable risks based upon the EBO preclinical findings, phase 1, phase 2, and Phase 3 experience; standard-of-care procedures; and the specified procedures of the study. Following receipt of informed consent, and a Screening period, eligible patients will be randomized to one of the 4 treatment groups to receive active or matched placebo EBO tablets for 84 days. Patients will be assessed for clinical and microbiological evidence of efficacy. At selected investigative sites, patients will undergo sparse PK sampling. Safety and tolerability will be determined by standard clinical and laboratory assessment, with oversight by a qualified and appropriately constituted Data Safety Monitoring Board (DSMB). Data collected during the study will be analyzed per a comprehensive Statistical Analysis Plan (SAP). The study will be registered on clinicaltrials.gov. The total duration of patient participation is approximately 6 months.

Clinical Study on the Early Bactericidal Activity of Contezolid Against Mycobacterium Abscessus Disease

This study is a single-center, randomized, controlled, open-label clinical trial designed to assess the early bactericidal activity of a single agent, contezolid, in patients with Mycobacterium abscessus infections. Patients were administered contezolid monotherapy for 14 days specifically targeting Mycobacterium abscessus, and were compared to a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug. The comparison was conducted through the analysis of colony forming units counts and Time To Positivity in sputum cultures. By evaluating the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus infections, this study aimed to assess the early bactericidal activity of contezolid, thereby providing a basis for the selection of new therapeutic options for the treatment of patients with Mycobacterium abscessus infections.

Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households: A Case-control Study of Exposure Risk at Home

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 fibrosis. Environmental samples from the homes of CF patients with and without NTM infection will be analyzed and genetically compared with available clinical isolates, alongside assessment of environmental risk factors, to improve understanding of exposure pathways and inform future prevention strategies.

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 Mycobacterium abscessus with goal to reduce infection burden and improve pulmonary disease

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