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

Status:	Completed
Conditions:	Pneumonia
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	7/25/2018
Start Date:	April 13, 2013
End Date:	April 7, 2017

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients With Gram-Negative Pneumonia

To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg
(amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System
(PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal
saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and
mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint
objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized
placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on
ventilation, and the days in the intensive care unit (ICU).

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)

We found this trial at

sites

Clinical Trial Facility in Mineola New York

Mineola, New York 11501

496

from 43215

Mineola, NY