Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

Inclusion Criteria:

- Males and non-pregnant, non-lactating females, 18 years of age or older

- Intubated and mechanically-ventilated

- Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on
chest radiograph

- Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory
secretions, or suspected Gram-negative pathogen

- Impaired oxygenation

- Clinical Pulmonary Infection Score (CPIS) of at least 6

- Presence of a multi-drug resistant (MDR) organism in a pre-therapy respiratory
specimen OR at least two risk factors for MDR organisms

Exclusion Criteria:

- History of hypersensitivity to amikacin or other aminoglycosides

- Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours
at the time of randomization

- Known or suspected bacteremia secondary to Staphylococcus aureus

- A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test

- Patients with a serum creatinine > 2 mg/dL (177 µmol/L) [Exception: Patients with a
serum creatinine > 2 mg/dL (177 µmol/L) and being treated with continuous renal
replacement therapy (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or
daily hemodialysis will receive the aerosol study drug treatment]

- Has been on mechanical ventilation for > 28 days

- Is participating in or has participated in other investigational interventional
studies within the last 28 days prior to study treatment

- The risk of rapidly fatal illness and death within 72 hrs, or any concomitant
condition not related to ventilator-associated pneumonia that, in the opinion of the
investigator, precludes completion of study evaluations and the course of therapy

- Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score < 10

- Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V
ECMO)