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

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What is this study about?

This clinical trial is focused on finding the best treatment for a lung disease caused by an infection with Mycobacterium abscessus. This is a type of bacteria that can cause serious lung problems. The study will test several antibiotics to see which combination works best to clear the infection and is well-tolerated by patients. The antibiotics being studied include clofazimine, tigecycline, clarithromycin, azithromycin, imipenem, doxycycline, cilastatin, amikacin, rifabutin, cefoxitin, linezolid, moxifloxacin, ethambutol, sulfamethoxazole, and trimethoprim. Some of these medications are given by mouth, while others are given through an injection or infusion.

The purpose of the study is to determine which treatment regimen is most effective in clearing the Mycobacterium abscessus infection from the lungs while being safe and tolerable for patients. Participants in the study will receive one or more of these antibiotics, and their progress will be monitored over a period of time. The study will look for negative cultures, which means no bacteria are found in the sputum samples, as a sign of successful treatment. The study will also assess how well patients tolerate the medications, with a focus on minimizing any side effects.

Participants will be involved in the study for different lengths of time, depending on the treatment they receive. Some treatments may last up to 58 weeks, while others may be shorter. The study aims to ensure that the treatments are both effective and safe, with the goal of improving the health and quality of life for people with this challenging lung infection.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be required to sign an informed consent form, which indicates your understanding and agreement to participate in the study.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests to ensure you meet the criteria for participation.

3 treatment phase

During the treatment phase, you will receive a combination of medications aimed at treating Mycobacterium abscessus pulmonary disease. The medications include clofazimine, tigecycline, clarithromycin, azithromycin, imipenem, doxycycline, cilastatin, rifabutin, bedaquiline, amikacin, sulfamethoxazole, cefoxitin, linezolid, moxifloxacin, ethambutol, and trimethoprim.

The medications will be administered in various forms, including oral (by mouth), intravenous (through a vein), and inhalation (breathed in). The specific dosage, frequency, and duration of each medication will be determined by the study protocol and your healthcare provider.

4 monitoring and follow-up

Throughout the trial, regular monitoring will be conducted to assess your response to the treatment and to check for any side effects. This may involve physical examinations, laboratory tests, and imaging studies.

You will be required to provide sputum samples at specified intervals to evaluate the clearance of the infection. The goal is to achieve negative cultures from four consecutive samples, with one collected four weeks after completing the treatment.

5 completion of the trial

At the end of the trial, a final assessment will be conducted to determine the outcome of the treatment. This includes evaluating the microbiological clearance of the infection and assessing your tolerance to the medications.

You will receive information about the results of the trial and any further steps or follow-up care that may be necessary.

Who Can Join the Study?

  • Must have a positive diagnosis of Mycobacterium abscessus pulmonary disease (MABS-PD) that meets specific criteria:
    • Clinical: Must have lung symptoms and other possible diagnoses must be ruled out.
    • Radiological: Must show specific patterns on a chest X-ray or a detailed chest scan, such as nodular or cavitary opacities, or multifocal bronchiectasis with multiple small nodules.
    • Microbiological: Must have positive MABS culture results from at least two separate sputum samples, or from at least one bronchial wash or lavage, or a lung biopsy showing specific features and positive culture for non-tuberculous mycobacteria (NTM).
  • Can be male or female of any age.
  • Must not have received treatment for MABS-PD in the 12 months before being assessed for eligibility.
  • Must provide informed consent, or have a parent/legal guardian provide consent if under 18 years of age.
  • Must be able to comply with study visits, therapies, and procedures as judged by the study investigator.

Who Cannot Join the Study?

  • Patients who are not able to provide consent to participate in the study.
  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients with a medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse that could interfere with the study.
  • Patients who have a serious mental health condition that could affect their ability to follow study instructions.
  • Patients who have had a major surgery within the last 30 days.
  • Patients who have a known infection with a different type of bacteria that could interfere with the study results.
  • Patients who have a history of non-compliance with medical treatments or study protocols.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Rigshospitalet Copenhagen Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
10.04.2023

Trial locations

Investigated drugs:

Amikacin is an antibiotic used to treat serious bacterial infections. In this trial, it is being used to help clear the Mycobacterium abscessus bacteria from the lungs. It works by stopping the bacteria from growing and multiplying, which helps the body fight off the infection.

Clarithromycin is another antibiotic that is part of the treatment plan for Mycobacterium abscessus. It helps by interfering with the bacteria’s ability to produce proteins, which are essential for their growth and survival. This action helps reduce the number of bacteria in the body.

Linezolid is an antibiotic that is used to treat infections caused by certain types of bacteria. In this trial, it is being used to target Mycobacterium abscessus. It works by stopping the bacteria from making proteins, which are necessary for their growth and reproduction.

Tigecycline is an antibiotic that is used to treat a variety of bacterial infections. It is included in this trial to help combat Mycobacterium abscessus. Tigecycline works by preventing the bacteria from producing proteins, which are crucial for their growth and survival.

Imipenem is an antibiotic that is used to treat severe infections caused by bacteria. In this trial, it is being used to help eliminate Mycobacterium abscessus. It works by breaking down the bacteria’s cell walls, which leads to their death.

Clofazimine is a medication that is used to treat certain bacterial infections, including Mycobacterium abscessus. It works by interfering with the bacteria’s DNA, which prevents them from growing and multiplying.

Investigated diseases:

Mycobacterium abscessus pulmonary disease – This disease is a lung infection caused by the bacterium Mycobacterium abscessus, which is part of the non-tuberculous mycobacteria group. It typically affects individuals with underlying lung conditions, such as cystic fibrosis or bronchiectasis. The disease progresses as the bacteria colonize the lungs, leading to symptoms like chronic cough, sputum production, and sometimes shortness of breath. Over time, the infection can cause lung damage and inflammation, resulting in worsening respiratory symptoms. The bacteria are known for their resistance to many common antibiotics, making the infection challenging to manage. The progression of the disease can vary, with some individuals experiencing more severe symptoms than others.

Trial ID:
2023-506575-99-00
Protocol code:
FORMaT001
NCT ID:
NCT04310930
Trial Phase:
Therapeutic exploratory (Phase II)

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