Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia

Exclusion Criteria

• •Subjects with compromised or suppressed Immune systems, severe hypoxemia, neutropenia, serum creatinine \> 2mg/dl and chronic liver disease
• •Had primary lung cancer or another malignancy metastatic to the lungs
• •Were known or suspected to have active tuberculosis, cystic fibrosis, acquired immunodeficiency syndrome, or Pneumocystis carinii pneumonia
• •Were receiving immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications
• •Had a body mass index of ≥30 kg/m2
• •Had burns \>40% of total body surface area
• •Had known local or systemic hypersensitivity to amikacin or aminoglycosides
• •Had a diagnosis of end-stage renal failure or were currently on dialysis treatment
• •Had a serum albumin level \<2 g/dL at Screening
• •Used amikacin by any route within 7 days before the start of study treatment
• •Had a presence of any concomitant condition that, in the opinion of the investigator, would preclude completion of study evaluations or make it unlikely that the contemplated course of therapy and Follow-Up could be completed
• •Had known respiratory colonization with amikacin-resistant gram-negative rods