A Study of Arikayce for Treatment of Mycobacteria that is not Tuberculosis


About this study

The purpose of this study is to evaluate the effectiveness, safety and tolerability of Amikacin for patients who have a mycobacterial lung disease that is not tuberculosis, and is difficult to treat.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Diagnosis of pulmonary nontuberculous mycobacterial lung disease in accordance with the 2007 ATS/IDSA criteria
  • Has evidence of nodular bronchiectasis and/or cavitary disease by chest computed tomography (CT)
  • History of chronic infection with either Mycobacterium avium complex or Mycobacterium abscessus or mixed infection with both species
    • Defined as at least 2 documented positive cultures in the prior 2 years, of which at least one was obtained in the 6 months prior to screening
  • Positive sputum culture obtained at screening visit with either Mycobacterium avium complex or Mycobacterium abscessus or mixed infection with one dominant species
  • Receiving ATS/IDSA guidelines-based treatment regimen defined as adherent to a multi-drug regimen for at least 6 months prior to screening with persistently positive mycobacterial cultures
  • Ability to produce at least 3 mL of sputum or be willing to undergo an induction that produces at least 3 mL of sputum for clinical evaluation
  • Female of childbearing potential agrees to practice an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD)

Exclusion Criteria

  • Forced Expiratory Volume in 1 second (FEV1) <30% of predicted at screening
  • Presence of any clinically significant cardiac disease as determined by Investigator
    •  QTc> 450 msec for males or QTc> 470 msec for females
  • Hemoptysis of ≥ 60 mL in a 24 hour period within 4 weeks prior to screening
  • Active pulmonary malignancy (primary or metastatic) 
  • Any malignancy requiring chemotherapy or radiation therapy within one year prior to screening or anticipated during the study period
  • Active allergic bronchopulmonary mycosis or any other condition requiring systemic steroids at a dose ≥ equivalent of 10 mg/day of prednisone within 3 months prior to screening or anticipated during the study period
  • Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening
  • History of lung transplantation
  • Hypersensitivity to aminoglycosides
  • Any change study day 1
  • Evidence of biliary cirrhosis with portal hypertension
  • History of daily, continuous oxygen supplementation
  • Smoking tobacco or any substance within 6 months prior to screening or anticipated inability to refrain from smoking throughout the study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Aksamit, M.D.

Closed for enrollment

More information


Publications are currently not available

Mayo Clinic Footer