Mycobacterium; XenopiPhase 2AKAPINCT06585020
Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection
A Phase 2 study testing Arikayce and standard treatment in people with Mycobacterium; Xenopi and Lung Diseases, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Indeed, this duration is based on the date of sputum conversion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium; Xenopi, Lung Diseases
- What is being tested?
- Arikayce and standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2024to Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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%.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, 80054
Claire Andréjak, MD
Frédéric GAGNADOUX, Pr
About this study
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. Indeed, this duration is based on the date of sputum conversion. Treatment should be continued until 12 months after sputum conversion. In the vast majority patients have converted after 6 months of treatment, so a 18 months duration in total. Unfortunately, few data are available for MX, as it is rare in USA, but it is the second NTM isolated in France and concerns an increasing number of patients. As it is uncommon in USA, no clinical studies conducted by the pharmaceutical laboratory will be planned. In a murine model of MX infection, the only drug which decreased the number colony formant units in mice lungs, was amikacin. Until now, amikacin was only available intravenously and used only for patients with very severe disease, because of renal and auditory toxicity. Amikacin liposome inhalation suspension (ARIKAYCE®) is amikacin sulfate encapsulated in liposomes for inhalational delivery. ARIKAYCE® increases amikacin uptake into alveolar macrophages, a refuge for NTM organisms; allows biofilm penetration; and limits systemic amikacin exposure ARIKAYCE® has already be tested in a randomized study on M. avium complex (MAC) refractory pulmonary infections. In this study, the culture conversion rate in the ARIKAYCE® group was higher than standard regimen group.
- Conditions
- Mycobacterium; Xenopi, Lung Diseases
- Being tested
- Arikayce, standard treatment
- Keywords
- Mycobacterium; Xenopi, Lung Diseases
- Medical subject headings
- Mycobacterium Infections, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArikayceDrug
Treatment regimens containing three molecules, rifampicin, ethambutol, and clarithromycin with ARIKAYCE® during the 6 first months of treatment. After having confirmed the presence of all inclusion criteria and the absence of all exclusion criteria, and after having obtained the patient's free and informed consent, the patient will be included and randomized to one of the treatment regimens.
treatment regimens containing three molecules, rifampicin, ethambutol, and clarithromycin during the 6 first months of treatment. After having confirmed the presence of all inclusion criteria and the absence of all exclusion criteria, and after having obtained the patient's free and informed consent, the patient will be included and randomized to one of the treatment regimens.
| Study group | Role | What they receive |
|---|---|---|
| ARIKAYCE | Experimental | Experimental arm = ARIKAYCE® during 6 months in addition to standard treatment (duration determined with date of sputum conversion) Receives: Drug: Arikayce |
| Standard treatment | Active comparator | Control arm = standard treatment Standard treatment = Rifampicin, ethambutol and clarithromycin Receives: Drug: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of sputum conversion rate in ARIKAYCE® addition group compared to standard treatment
Measured: 3 months
Secondary outcomes (3)
variation of time to culture conversion between both groups
Measured: at 3 month
variation of mortality between both groups
Measured: at 12 months
variation of mortality between both groups
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start20 Oct 2024
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium; XenopiStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers, Hospital Avicenne, University Hospital, Bordeaux, University Hospital, Brest, Centre Hospitalier Intercommunal de Compiègne-Noyon, Créteil Hospital, Centre Hospitalier Universitaire Dijon, University Hospital, Grenoble, Centre Hospitalier le Mans, Hôpital de la Croix-Rousse, APHM - Nord, Hôpital Saint Joseph, CH Mulhouse, CH Orléans, Tenon Hospital, Paris, Hôpital Necker-Enfants Malades, Perpignan Hospital Center, Poitiers University Hospital, CH Pontoise, CHU de Reims, Rennes University Hospital, CHU de Rouen - Accueil, Central Hospital Saint Quentin, IHU Strasbourg, University Hospital, Tours, Abbeville Hospital Center, CH Cannes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585020
- Sponsor's protocol ID
- PI2021_843_0148
- Acronym
- AKAPI
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection
- ClinicalTrials.gov ID
- NCT06585020
- Acronym / sponsor ID
- AKAPI / PI2021_843_0148
- Conditions
- Mycobacterium; Xenopi, Lung Diseases
- Keywords
- Mycobacterium; Xenopi, Lung Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Angers, Hospital Avicenne, University Hospital, Bordeaux, University Hospital, Brest, Centre Hospitalier Intercommunal de Compiègne-Noyon, Créteil Hospital, Centre Hospitalier Universitaire Dijon, University Hospital, Grenoble, Centre Hospitalier le Mans, Hôpital de la Croix-Rousse, APHM - Nord, Hôpital Saint Joseph, CH Mulhouse, CH Orléans, Tenon Hospital, Paris, Hôpital Necker-Enfants Malades, Perpignan Hospital Center, Poitiers University Hospital, CH Pontoise, CHU de Reims, Rennes University Hospital, CHU de Rouen - Accueil, Central Hospital Saint Quentin, IHU Strasbourg, University Hospital, Tours, Abbeville Hospital Center, CH Cannes
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Indeed, this duration is based on the date of sputum conversion. Treatment should be continued until 12 months after sputum conversion. In the vast majority patients have converted after 6 months of treatment, so a 18 months duration in total. Unfortunately, few data are available for MX, as it is rare in USA, but it is the second NTM isolated in France and concerns an increasing number of patients. As it is uncommon in USA, no clinical studies conducted by the pharmaceutical laboratory will be planned. In a murine model of MX infection, the only drug which decreased the number colony formant units in mice lungs, was amikacin. Until now, amikacin was only available intravenously and used only for patients with very severe disease, because of renal and auditory toxicity. Amikacin liposome inhalation suspension (ARIKAYCE®) is amikacin sulfate encapsulated in liposomes for inhalational delivery. ARIKAYCE® increases amikacin uptake into alveolar macrophages, a refuge for NTM organisms; allows biofilm penetration; and limits systemic amikacin exposure ARIKAYCE® has already be tested in a randomized study on M. avium complex (MAC) refractory pulmonary infections. In this study, the culture conversion rate in the ARIKAYCE® group was higher than standard regimen group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARIKAYCE | Experimental | Drug: ArikayceExperimental arm = ARIKAYCE® during 6 months in addition to standard treatment (duration determined with date of sputum conversion) |
| Standard treatment | Active comparator | Drug: standard treatmentControl arm = standard treatment Standard treatment = Rifampicin, ethambutol and clarithromycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (52 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArikayceTreatment regimens containing three molecules, rifampicin, ethambutol, and clarithromycin with ARIKAYCE® during the 6 first months of treatment. After having confirmed the presence of all inclusion criteria and the absence of all exclusion criteria, and after having obtained the patient's free and informed consent, the patient will be included and randomized to one of the treatment regimens. | Drug | ARIKAYCE |
| standard treatmenttreatment regimens containing three molecules, rifampicin, ethambutol, and clarithromycin during the 6 first months of treatment. After having confirmed the presence of all inclusion criteria and the absence of all exclusion criteria, and after having obtained the patient's free and informed consent, the patient will be included and randomized to one of the treatment regimens. | Drug | Standard treatment |
Primary outcome
variation of sputum conversion rate in ARIKAYCE® addition group compared to standard treatment
Time frame: 3 months
3 secondary outcomes
variation of time to culture conversion between both groups
Time frame: at 3 month
variation of mortality between both groups
Time frame: at 12 months
variation of mortality between both groups
Time frame: at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arikayce and standard treatment in people with Mycobacterium; Xenopi and Lung Diseases, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire ANDREJAK, Pr (03 22 08 79 98 ext. 33, Andrejak.Claire@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of sputum conversion rate in ARIKAYCE® addition group compared to standard treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.