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Study on Amikacin for Treating Mycobacterium Xenopi Lung Infection in Patients Using Amikacin and Drug Combination

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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 a lung infection caused by a type of bacteria called Mycobacterium xenopi. The study is testing a treatment that includes a medication called ARIKAYCE, which is an inhaled form of the antibiotic amikacin. This medication is being added to the standard treatment to see if it improves the rate at which the bacteria are cleared from the lungs over a period of three months. The standard treatment may include other antibiotics such as rifampicin, amoxicillin, and ethambutol hydrochloride, which are taken orally.

The purpose of the study is to determine if adding ARIKAYCE to the usual treatment is more effective than the standard treatment alone. Participants in the study will receive either the standard treatment or the standard treatment plus ARIKAYCE. The study will monitor the participants over a period of up to six months to assess the effectiveness of the treatment in clearing the infection from the lungs. The study will also look at other outcomes such as the recurrence of the infection, any failures or relapses, and the overall safety of the treatment.

Participants will be required to undergo regular check-ups and provide samples to measure the presence of the bacteria in their lungs. The study aims to provide valuable information on the best way to treat Mycobacterium xenopi lung infections and improve patient outcomes. The results of this study could lead to better treatment options for those affected by this type of lung infection.

The research process

The trial runs in 5 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 respiratory symptoms and microbiological evidence of Mycobacterium xenopi infection.

  2. Step 2

    Initial treatment phase

    The treatment begins with the administration of rifampicin, amoxicillin, and ethambutol hydrochloride. These medications are taken orally.

    The dosage and frequency of these medications are determined by the study protocol and are aimed at managing the pulmonary infection.

  3. Step 3

    Addition of inhalation therapy

    In addition to the oral medications, ARIKAYCE liposomal 590 mg is administered through inhalation. This is a nebuliser dispersion designed to target the infection directly in the lungs.

    The inhalation therapy is intended to enhance the treatment's effectiveness over a period of three months.

  4. Step 4

    Monitoring and evaluation

    Throughout the treatment, regular monitoring is conducted to assess the sputum conversion rate at three months. This involves checking if the infection is responding to the treatment.

    Additional evaluations may occur at six months to monitor for recurrence, failure, relapse, cure, or any adverse effects.

  5. Step 5

    Completion of treatment

    The study aims to demonstrate the effectiveness of adding ARIKAYCE to the standard treatment regimen.

    The primary goal is to achieve a successful sputum conversion, indicating a reduction or elimination of the infection.

Who can join the trial?

7 criteria

  • You must be **18 years old or older**.
  • You must meet the **2020 ATS/ERS/ESCMID/IDSA criteria** for a type of lung infection caused by bacteria that are not the usual ones causing tuberculosis.
  • You should have **respiratory symptoms** and a **nodular or cavitary lesion** on a chest x-ray, which is confirmed by a detailed chest scan. These lesions might also appear as a **diffuse micronodular syndrome**, which means small nodules spread throughout the lungs.
  • You need to meet **microbiological criteria**, which means:
    • Having at least **two positive cultures** for the specific bacteria on two different days, with at least 7 days apart, OR
    • A **positive culture** for the bacteria from a lung wash or a sample taken during a lung examination, OR
    • A **lung biopsy** showing signs of this bacterial infection and a positive culture, OR a biopsy showing signs of infection and one or more positive cultures from sputum.
    • Other possible diagnoses must be **excluded** through scans, lung examinations, and lab tests.

Who cannot join the trial?

10 criteria

  • Patients who have a different lung infection than the one being studied cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have a medical condition that might interfere with the study or make it unsafe for them cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent surgery or are planning to have surgery during the study period cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of allergic reactions to the study medication cannot participate.
  • Patients who have a history of substance abuse or alcohol abuse cannot participate.
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Investigated drugs

  • ARIKAYCE

    This is an inhalation medication that contains amikacin, an antibiotic. It is used in this trial to treat lung infections caused by Mycobacterium xenopi. The medication is delivered directly to the lungs to help clear the infection more effectively. The trial aims to see if adding ARIKAYCE to the standard treatment improves the rate at which patients' sputum tests negative for the bacteria after three months.

  • Standard Treatment

    This refers to the usual medications and therapies used to treat Mycobacterium xenopi lung infections. The standard treatment typically includes a combination of antibiotics that are taken over a long period to help eliminate the infection. The trial compares the effectiveness of the standard treatment alone versus the standard treatment combined with ARIKAYCE.

What is already known about the treatment

Arikayce – This medication is administered as an inhalation suspension, specifically designed for delivery directly to the lungs. It is currently being studied in clinical trials for its effectiveness in treating Mycobacterium xenopi pulmonary infection. The main therapeutic indication is to improve the sputum conversion rate in patients with this type of lung infection. Arikayce works by delivering amikacin, an antibiotic, directly to the site of infection, where it disrupts bacterial protein synthesis, leading to bacterial cell death. It is classified as an aminoglycoside antibiotic.

Investigated diseases

Mycobacterium xenopi pulmonary infection – This is a lung infection caused by the bacterium Mycobacterium xenopi, which is part of the non-tuberculous mycobacteria group. It primarily affects individuals with weakened immune systems or pre-existing lung conditions. The infection can lead to symptoms such as chronic cough, fatigue, weight loss, and fever. Over time, it may cause progressive lung damage if not managed properly. The disease is characterized by its slow progression and can be challenging to diagnose due to its similarity to other lung infections. It is not considered a rare disease, but it requires specific medical attention to manage its symptoms and progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506843-40-00Protocol codePI2021_843_0148Estimated enrolment190 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

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