AKAPI: Amikacin Liposome Inhalation Suspension for treatment of Mycobacterium xenopi pulmonary infection: A prospective controlled open-label randomized study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506843-40-00

Acronym

PI2021_843_0148

Enrollment

190

Registered

2024-07-15

Start date

2025-10-29

Completion date

Unknown

Last updated

2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycobacterium xenopi pulmonary infection

Brief summary

3 months sputum conversion rate

Detailed description

6 months sputum conversion rate, recurrence, failure, relapse, cure, death and safety

Interventions

DRUGARIKAYCE liposomal 590 mg nebuliser dispersion

DRUGRIFAMPICIN

DRUGDEXAMBUTOL 500 mg

DRUGcomprimé pelliculé

DRUGCLARITHROMYCIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
3 months sputum conversion rate	—

Secondary

Measure	Time frame
6 months sputum conversion rate, recurrence, failure, relapse, cure, death and safety	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026