Ongoing Clinical Trials for Mycobacterium abscessus Infection
Currently, there is 1 ongoing clinical trial investigating treatment options for Mycobacterium abscessus infection, a challenging lung disease caused by a type of bacteria that is resistant to many common antibiotics. This trial is testing combinations of multiple antibiotics to find the most effective and tolerable treatment regimen for patients with this condition.
Clinical trial locations
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.
Summary
Currently, only one clinical trial is actively recruiting patients with Mycobacterium abscessus infection, and it is being conducted in Denmark. This trial takes a comprehensive approach by testing multiple antibiotic combinations to address the challenge of treating this antibiotic-resistant bacterial infection. The study reflects the complexity of treating Mycobacterium abscessus, as it requires long treatment durations and combinations of several different medications. The focus on both effectiveness and tolerability demonstrates the importance of finding treatments that patients can complete successfully. Patients interested in this trial should discuss their eligibility with their healthcare provider, particularly regarding the requirement that they have not received treatment for this condition in the past 12 months.
