Mycobacterium abscessus infection Trials in Disease

Study on the Effectiveness of Clofazimine and Drug Combination for Treating Mycobacterium abscessus Lung Disease in Adult Patients

This clinical trial is investigating the best treatment approach for lung disease caused by Mycobacterium abscessus bacteria. The study is testing several antibiotics in combination to determine which regimen works most effectively to clear the infection while remaining safe and well-tolerated by patients.

Main inclusion criteria:

• Must have a confirmed diagnosis of Mycobacterium abscessus pulmonary disease based on clinical symptoms, chest imaging showing specific patterns, and positive bacterial cultures from sputum samples, bronchial wash, or lung biopsy
• Can be male or female of any age
• Must not have received treatment for this condition in the 12 months before joining the study
• Must be able to provide informed consent or have a parent or legal guardian provide consent if under 18 years of age
• Must be able to attend study visits and follow treatment protocols as required

Main exclusion criteria:

• Unable to provide consent to participate
• History of severe allergic reactions to any of the study medications
• Currently participating in another clinical trial
• Medical conditions that would make participation unsafe
• Pregnant or breastfeeding
• History of drug or alcohol abuse that could interfere with the study
• Serious mental health conditions affecting ability to follow study instructions
• Major surgery within the last 30 days
• Known infection with a different type of bacteria that could interfere with results
• History of not following medical treatments or study protocols

Focus and goals:

The main goal of this trial is to find the most effective antibiotic combination to clear Mycobacterium abscessus from the lungs while ensuring the treatment is safe and tolerable. The study will monitor participants for negative bacterial cultures, meaning no bacteria are found in sputum samples, as a sign of successful treatment. Participants will be closely monitored throughout the trial, with treatment lasting up to 58 weeks depending on the specific regimen received. The study aims to improve health and quality of life for people living with this challenging lung infection.

Investigational drugs:

The trial is testing multiple antibiotics, which may be given by mouth, through injection, or by inhalation. These include:

• Amikacin: An antibiotic that stops bacteria from growing and multiplying
• Clarithromycin: Works by interfering with the bacteria's ability to produce proteins essential for their survival
• Linezolid: Prevents bacteria from making proteins necessary for their growth and reproduction
• Tigecycline: Stops bacteria from producing proteins crucial for their survival
• Imipenem: Breaks down the bacteria's cell walls, leading to their death
• Clofazimine: Interferes with the bacteria's DNA to prevent growth and multiplication

Other antibiotics being tested include azithromycin, doxycycline, cilastatin, rifabutin, bedaquiline, cefoxitin, moxifloxacin, ethambutol, sulfamethoxazole, and trimethoprim.

Participants will undergo regular monitoring throughout the trial, including physical examinations, laboratory tests, and imaging studies. They will need to provide sputum samples at specified intervals to evaluate whether the infection is being cleared. The goal is to achieve negative cultures from four consecutive samples, with one collected four weeks after completing treatment.