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

Inclusion Criteria:

- Male or female subjects with confirmed pneumonia, defined as the presence of a new
progressive infiltrate(s) on chest radiograph and the presence of gram-negative
organism by either culture or Gram stain of respiratory secretions. The subject must
be intubated and mechanically ventilated and expected to remain so for at least 3
days after the start of study treatment. Subjects with a tracheostomy were also
eligible.

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