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

1 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Le Mans Le Mans France
Hopital Saint Joseph Marseille France
Hopital NOVO Pontoise France
Centre Hospitalier Intercommunal Compiegne Noyon Compiegne France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Centre Hospitalier De Cannes Simone Veil Cannes France
Centre Hospitalier De Saint-Quentin Saint Quentin France
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier Universitaire Rouen Rouen France
Hopital Tenon Paris France
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
Hôpital Avicenne Bobigny France
Centre Hospitalier Universitaire d’Orléans Orléans France
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
Centre Hospitalier Universitaire De Toulouse Toulouse France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hôpital Pontchaillou-CHU Rennes Rennes France
Cjccba Hubunqcyhis Dhkvzuqcmlfcydlom Abbeville France
Cni drhoiksjfypqof Epagny Metz Tessy France
Chntuv Hsgnvgtrlhp Uavjnkkkadegz Dz Dvskz Dijon France
Asgcqjtbqr Pscvyzmb Hmvewhyn Df Msmxqxglw Marseille France
Cvifaf Hvmgwzxpntf Rhzlhlne Uuwondhdiqtqd Dj Tbjjz Tours France
Cqhajy Hbcmlkewdle Ulkbpdwiqrcrz Rqeuy Reims France
Csykzz Hyoowfypwhw Rphvsrtu Deyagxfjvpooji Angers France
Cmg Cibcs Rlzeyjjfhgm Lyon France

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

Trial status

Country Status Recruitment Start
France France
Recruiting
01.07.2024

Trial locations

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.

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 ID:
2023-506843-40-00
Protocol code:
PI2021_843_0148
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on the Safety and Effects of VERT-002 for Patients with Advanced Solid Tumors, Including Lung Cancer with MET Alterations

    Recruiting

    1 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain
  • Evaluation of mRNA-4359 Monotherapy and Combined Pembrolizumab Therapy in Advanced Solid Tumors: A Phase 1/2 Clinical Trial

    Recruiting

    1 1 1
    Germany Italy Poland Spain