Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease
Completed · Phase 2
Conditions studied: Mycobacterium Infections, Nontuberculous, Mycobacteria, Atypical
In brief
The proposed study will assess the efficacy, safety and tolerability of once daily dosing of Liposomal-Amikacin for Inhalation (LAI) 590 mg for 12 months plus standard of care (SOC) mycobacterial multi-drug regimen in accordance with the 2007 ATS/ IDSA guidelines, for treatment of mycobacterium abscessus lung disease.
Key facts
- Study ID
- NCT03038178
- Run by
- Kevin Winthrop
- People needed
- 30
- Starts
- 2016-10-01
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2020-03-04
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female patients 12 years and older
- Diagnosis of M. abscessus, including all subspecies, abscessus, bolleti, and massiliense lung disease according to the 2007 ATS/IDSA criteria
- Both newly diagnosed and currently on treatment or previously treated patients will be included
- Culture positive (either sputum or bronchoscopy) for M. abscessus at time of screening
- Willingness to adhere to a treatment regimen, study visits, and study procedures during the course of the study.
- Ability to produce at approximately 3.0 mL of sputum or be willing to undergo an induction that produces approximately 3.0 mL of sputum for culture collection
- Female of childbearing potential agrees to practice an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD)
- Written informed consent or assent obtained from the patient, parent or legal guardian prior to the performance of any study related procedures
You may not qualify if…
- Active pulmonary tuberculosis requiring treatment at screening
- Treatment with inhaled or intravenous Amikacin within 14 days prior to baseline
- Known hypersensitivity to aminoglycosides
- Aspartate aminotransferase or alanine aminotransferase ≥ 3 times the upper limit of normal or total bilirubin ≥ 2 times the upper limit of normal (ULN) at screening
- Current addiction to alcohol or illicit drug abuse
- Any condition which in the opinion of the Investigator interferes with ability to adhere to study requirements
- Primary immunodeficiency syndromes and acquired immunodeficiency syndromes (e.g., HIV-positive patients regardless of CD4 counts)
- Absolute neutrophil count ≤500/μL at Screening
- Significant (as determined by the investigator) hearing loss, vestibular dysfunction, neuromuscular weakness or a diagnosis of myasthenia gravis, where the potential risk of aminoglycoside toxicity outweighs the potential benefit
- Serum creatinine >2 times ULN at Screening
- History of lung transplantation
- Any condition that, in the judgment of the Investigator, would compromise the ability of the subject to complete the study
Where it is running
- Oregon Health & Science University — Portland, Oregon, United States
- University of Texas Health Science Center — Tyler, Texas, United States
Full record on ClinicalTrials.gov
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