Inhaled drug offers new hope for stubborn lung infection
NCT ID NCT06585020
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding an inhaled form of the antibiotic amikacin (ARIKAYCE) to standard treatment helps clear Mycobacterium xenopi from the lungs faster. About 190 adults with this rare, hard-to-treat lung infection will receive either standard care alone or standard care plus the inhaled drug. The goal is to see if sputum becomes bacteria-free sooner, which could shorten treatment and improve outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 190 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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%.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Amiens-Picardie
RECRUITINGAmiens, 80054, France
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