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