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New treatment option for Mycobacterium; Xenopi
Official title Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection
ClinicalTrials.gov ID: NCT06585020
What this study is testing
What is Arikayce?
Arikayce is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mycobacterium; xenopi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Treatment of Mycobacterium xenopi (MX) lung disease is not-well- tolerated and concerned a growing number of patients, especially with chronic pulmonary diseases or immunosuppression. The outcome of these patients is poor, and treatment is very long.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years old or older
- with an highly effective or acceptable contraception
- must present ATS/IDSA 2020 criteria for nontuberculous mycobacterial pulmonary infection
- the NTM should be M. xenopi
You likely can't join if
- Patients presenting any of the following criteria cannot be included:
- Known hypersensitivity to one of the molecules of the study
- Relapse of MX lung infection
- Treatment with molecules able to interfere with cytochrome P450 that cannot be replaced by another therapeutic class
- HIV 1 and 2 human immunodeficiency virus infection
- Renal failure with creatinine clearance less than 30 mL/min
See the full eligibility criteria
- 18 years old or older
- with an highly effective or acceptable contraception
- must present ATS/IDSA 2020 criteria for nontuberculous mycobacterial pulmonary infection
- the NTM should be M. xenopi
- Patients presenting any of the following criteria cannot be included:
- Known hypersensitivity to one of the molecules of the study
- Relapse of MX lung infection
- Treatment with molecules able to interfere with cytochrome P450 that cannot be replaced by another therapeutic class
- HIV 1 and 2 human immunodeficiency virus infection
- Renal failure with creatinine clearance less than 30 mL/min
- Pregnancy and breastfeeding
- Cystic fibrosis
- Contraindications to one of the antibiotic : Contraindication to the use of ARIKAYCE®:
- Hypersensitivity to the active substance, to aminoglycosides or to any of the excipients listed in section 6.1 of the CPR.
- Hypersensitivity to soy.
- Co-administration with any other aminoglycoside, regardless of the route of administration
- Severe Renal Failure Contraindication to the use of Clarithromycine: Allergy to macrolides or to any of the excipients listed in section 6.1;
- Association with :
- colchicine,
- ergot alkaloids, including for example dihydroergotamine, ergotamine, methylergometrine, methysergide: risk of ergotism,
- pimozide, mizolastine: risk of QT interval prolongation and cardiac rhythm disorders, in particular ventricular tachycardia, ventricular fibrillation and torsades de pointes,
- simvastatin, due to the increased risk of myopathy, including rhabdomyolysis.
- lomitapide,
- alfuzosin
- dapoxetine
- avanafil
- ivabradine,
- eplerenone,
- dronedarone,
- Quetiapine,
- ticagrelor,
- cisapride,
- astemizole,
- terfenadine,
- ranolazine,
- domperidone,
- Congenital or acquired prolongation of the QT interval (see sections 4.4 and 4.5 of the CPR)
- History of QT interval prolongation or ventricular rhythm disorders, in particular torsades de pointe (see sections 4.4 and 4.5 of the CPR);
- Electrolyte imbalances (hypokalaemia or hypomagnesaemia, due to the risk of QT interval prolongation) (see sections 4.4 and 4.5 of the CPR).Clarithromycin should not be used in patients with severe hepatic insufficiency...
- Hypersensitivity to rifamycins or to any of the excipients listed in section 6.1 of the CPR.
- Porphyrias.
- Association with bictegravir, cobicistat, daclatasvir, dasabuvir, delamanid, grazoprevir/elbasvir, ritonavir-boosted protease inhibitors, isavuconazole, lédipasvir, lurasidone, midostaurine, ombitasvir/paritaprévir...
- Known hypersensitivity to ethambutol
- Optic neuritis
- This medicine is contraindicated in patients with a wheat allergy (other than coeliac disease).
- Inability to comply with the requirements of the protocol, especially substance abuse, according to the investigator.
- Limited life expectancy (e.g 3 months)
- Patients with hematologic malignancies and allogeneic haematopoietic stem cells
- Women of childbearing age and not using an effective method of contraception (Pearl Index \<1%)
- The patient is treated with molecules prolonging the QT interval that cannot be replaced by another therapeutic class.
- The patient presents a heart failure with left ventricular ejection fraction less than 30%.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.