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Study Comparing Clarithromycin and Azithromycin for Treating Mycobacterium Avium Complex Lung Infections in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of lung infections caused by the Mycobacterium avium complex, a type of bacteria that can lead to serious respiratory issues. The study compares two medications: clarithromycin and azithromycin. Both are antibiotics commonly used to treat bacterial infections. The purpose of the study is to determine if azithromycin is as effective as clarithromycin in treating these lung infections.

Participants in the study will receive either clarithromycin or azithromycin over a period of time, and their progress will be monitored to see how well the bacteria in their lungs respond to the treatment. The main goal is to see if the bacteria are cleared from the lungs after six months of treatment. The study will also look at other factors, such as any side effects from the medications and improvements in lung health as seen on scans.

Throughout the study, participants will have regular check-ups to monitor their health and the effectiveness of the treatment. This includes checking for any digestive issues or liver problems, as well as assessing overall health improvements. The study aims to provide more options for doctors in choosing the best treatment for patients with Mycobacterium avium complex lung infections.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria related to Mycobacterium avium complex (MAC) lung disease. This includes respiratory symptoms and specific findings on a chest scan, as well as positive cultures for MAC.

  2. Step 2

    Randomization and treatment assignment

    Participants are randomly assigned to receive either clarithromycin or azithromycin as part of their treatment regimen. This is to compare the effectiveness of these two medications in treating MAC lung disease.

  3. Step 3

    Medication administration

    The treatment involves taking medications orally. The medications include Rifampicin (300 mg capsule), Clarithromycin (500 mg modified-release tablet), Ethambutol hydrochloride (500 mg film-coated tablet), and Azithromycin (250 mg film-coated tablet).

    The specific dosage and frequency of each medication are determined by the study protocol and are administered over a period of six months.

  4. Step 4

    Monitoring and assessments

    Throughout the study, regular monitoring is conducted to assess the treatment's effectiveness and safety. This includes checking for negative sputum conversion, which means the absence of MAC in sputum samples after six months.

    Additional assessments include monitoring for any digestive issues, liver function, and clinical and radiological improvements.

  5. Step 5

    Follow-up evaluations

    Follow-up evaluations occur at three and twelve months to check for sputum conversion and overall health outcomes. This includes checking for any new symptoms or changes in existing conditions.

  6. Step 6

    Completion of the study

    The study concludes with a final evaluation of the treatment's effectiveness and safety. The primary endpoint is the six-month negative sputum conversion rate, while secondary endpoints include safety assessments and clinical improvements.

Who can join the trial?

10 criteria

  • The patient must be 18 years old or older.
  • The patient must meet the ATS/IDSA 2007 criteria for a type of lung infection caused by bacteria that are not the usual tuberculosis bacteria. This includes:
    • Clinical criteria: The patient must have breathing problems and a specific type of lung damage seen on a special chest scan called a high-resolution computed tomography (CT) scan. This damage can look like small nodules or cavities in the lungs.
    • Microbiological criteria: The patient must have at least two positive test results for the bacteria called Mycobacterium avium complex (MAC) from two different samples of mucus from the lungs taken on different days.
    • Alternatively, a positive test for MAC from a sample taken during a procedure called bronchoalveolar lavage or bronchoscopic aspiration is acceptable.
    • Alternatively, a lung tissue sample taken during a procedure called transbronchial biopsy or surgical lung biopsy must show signs of infection by mycobacteria, such as a specific type of inflammation called a granuloma or a positive result on a special stain test, along with a positive culture for MAC.
    • Alternatively, a biopsy showing signs of mycobacterial infection and one or more positive cultures for MAC from mucus samples is acceptable.
    • Other possible causes of the symptoms must be ruled out using CT scans, a procedure called bronchoscopy, and other tests. If common bacteria are found, the symptoms and lung damage must continue even after proper antibiotic treatment to suggest a MAC infection.
    • If there are signs of another infection called Aspergillus fumigatus along with signs of MAC infection, the patient may have both infections.
    • Both male and female patients can participate.
    • The study does not include vulnerable populations.

Who cannot join the trial?

8 criteria

  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have a history of allergic reactions to azithromycin or clarithromycin, which are the drugs being studied.
  • Patients who are currently participating in another clinical trial or have participated in one within the last 30 days.
  • Patients with severe liver disease, as this can affect how the body processes the medication.
  • Patients with a history of heart rhythm problems, as the study drugs can affect heart rhythm.
  • Patients who are pregnant or breastfeeding, as the effects of the study drugs on unborn babies or infants are not fully known.
  • Patients with a known infection with a different type of bacteria that requires treatment with other antibiotics.
  • Patients who have a condition that, in the opinion of the study doctor, would make participation unsafe or affect the study results.
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Investigated drugs

  • Clarithromycin

    is an antibiotic used in this study to treat lung infections caused by Mycobacterium avium complex (MAC). It works by stopping the growth of bacteria, helping to clear the infection from the lungs.

  • Azithromycin

    is another antibiotic being tested in this trial for its effectiveness in treating MAC lung infections. Like clarithromycin, it helps to stop the growth of bacteria, aiming to clear the infection from the lungs.

What is already known about the treatment

  • Azithromycin

    Azithromycin is an antibiotic administered orally, typically in tablet or liquid form, and is used to treat various bacterial infections. It is currently well-established in medical practice and literature, particularly for respiratory infections. The main therapeutic indication in this trial is for Mycobacterium avium complex (MAC) pulmonary infections. Azithromycin works by inhibiting bacterial protein synthesis, effectively stopping the growth of bacteria. It belongs to the pharmacological class of macrolide antibiotics.

  • Clarithromycin

    Clarithromycin is an antibiotic that is usually taken orally in tablet or liquid form, and it is used to treat a range of bacterial infections. It is widely recognized in medical literature and practice, especially for respiratory and skin infections. In this trial, its primary use is for treating Mycobacterium avium complex (MAC) lung disease. Clarithromycin functions by interfering with bacterial protein synthesis, thereby halting bacterial growth. It is classified as a macrolide antibiotic.

Investigated diseases

Mycobacterium avium complex lung disease – This is a chronic lung infection caused by a group of bacteria known as Mycobacterium avium complex (MAC). It primarily affects individuals with pre-existing lung conditions or weakened immune systems. The disease progresses slowly, often starting with symptoms like a persistent cough, fatigue, and weight loss. Over time, it can lead to more severe respiratory issues, including shortness of breath and chest pain. The bacteria can cause inflammation and damage to lung tissue, leading to the formation of nodules or cavities. The progression of the disease can vary, with some individuals experiencing stable symptoms while others may see a gradual worsening of their condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518578-15-00Protocol codePI2017_843_0010Estimated enrolment424 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

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