Pneumonia

- 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.

- 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