Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT06585020
Eligibility Criteria:
Inclusion 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
Exclusion Criteria:
* 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 in association with renal insufficiency.
Contraindication to the use of Rifampicine:
* 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, praziquantel, rilpivirine, sofosbuvir, velpatasvir, voriconazole, voxilaprévir, (see section 4. 5 of the CPR). In children under 6 years of age, due to the risk of malaria
Contradiction the the use of Ethambutol:
* 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%.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06585020
Study Brief:
Protocol Section:
NCT06585020