Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585020
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AKAPI
Brief 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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None