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