In short
Currently, there is 1 ongoing clinical trial investigating treatment options for Mycobacterium avium complex infection, a chronic lung infection caused by a group of bacteria. The trial is being conducted in France and compares two antibiotic treatments to determine which is more effective at clearing the infection from the lungs.
Clinical trial locations
Study Comparing Clarithromycin and Azithromycin for Treating Mycobacterium Avium Complex Lung Infections in Adults
This trial is designed to compare two antibiotic medications, clarithromycin and azithromycin, in treating lung infections caused by Mycobacterium avium complex bacteria. The main purpose is to determine whether azithromycin is as effective as clarithromycin in clearing these serious respiratory infections.
Who can participate:
- Adults aged 18 years or older
- Patients who meet specific diagnostic criteria including respiratory symptoms and lung damage visible on high-resolution CT scans
- Patients with at least two positive test results for Mycobacterium avium complex from different mucus samples, or one positive result from a bronchoalveolar lavage procedure
- Patients with lung tissue samples showing signs of mycobacterial infection along with positive cultures
- Both men and women are eligible to participate
Who cannot participate:
- Patients unable to follow study procedures or take medications as required
- Patients with a history of allergic reactions to azithromycin or clarithromycin
- Patients currently in another clinical trial or who participated in one within the last 30 days
- Patients with severe liver disease
- Patients with a history of heart rhythm problems
- Pregnant or breastfeeding women
- Patients with other bacterial infections requiring different antibiotic treatment
- Patients with conditions that could make participation unsafe or affect study results
What the trial involves:
Participants are randomly assigned to receive either clarithromycin or azithromycin, both given as oral tablets. The treatment also includes other medications such as rifampicin and ethambutol hydrochloride as part of a complete treatment regimen. The medications are taken over a six-month period.
Throughout the trial, participants undergo regular monitoring to assess how well the treatment is working. The main goal is to see if the bacteria are cleared from the lungs after six months of treatment. Doctors will check mucus samples to confirm whether the bacteria are no longer present. Additional assessments include monitoring for digestive issues, liver function, and improvements in lung health as seen on scans.
Follow-up evaluations occur at three months and twelve months after treatment begins to check for continued absence of bacteria and overall health improvements. The study also carefully monitors any side effects from the medications throughout the treatment period.
Investigational drugs:
Clarithromycin is a macrolide antibiotic that works by stopping bacterial growth. It interferes with bacterial protein synthesis, preventing the bacteria from multiplying and helping to clear the infection from the lungs.
Azithromycin is another macrolide antibiotic being tested for effectiveness against these lung infections. It functions similarly to clarithromycin by inhibiting bacterial protein synthesis and stopping bacterial growth.
Summary
Currently, only one clinical trial is actively recruiting patients with Mycobacterium avium complex infection. This trial is being conducted in France and focuses on comparing two well-established antibiotics from the same drug class—macrolides—to determine which provides better treatment outcomes. Both clarithromycin and azithromycin are already used in medical practice for various bacterial infections, but this study specifically aims to establish which is more effective for clearing Mycobacterium avium complex from the lungs. The trial emphasizes careful monitoring of both treatment effectiveness and safety, with particular attention to potential side effects such as digestive issues, liver function changes, and heart rhythm problems. The study requires a six-month treatment period with follow-up assessments extending to one year, reflecting the chronic nature of this bacterial infection and the need for sustained treatment monitoring.
