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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pneumonia, Bacterial

In brief

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).

Key facts

Study ID

NCT01799993

Run by

Bayer

People needed

725

Starts

2013-04-13

Expected to finish

2017-04-07

Last updated by the study team

2018-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Danbury, Connecticut, United States
• Study site — Hartford, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Hollywood, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Springfield, Illinois, United States
• Study site — Muncie, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Hazard, Kentucky, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Springfield, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Butte, Montana, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Brooklyn, New York, United States
• Study site — Mineola, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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