Trial Condition(s):

Pneumonia, Bacterial

Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the treatment of Gram-Negative Pneumonia (INHALE 1)

Bayer Identifier:

13084

ClinicalTrials.gov Identifier:

NCT01799993

EudraCT Number:

2013-001048-73

Study Completed

Trial Purpose

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)

Trial Summary

Enrollment Goal
725
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Amikacin Inhalation Solution (BAY41-6551)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Mineola, United States, 10065

Status
Completed
 
Locations

Investigative Site

Miami, United States, 33125

Status
Completed
 
Locations

Investigative Site

Hazard, United States, 41701

Status
Completed
 
Locations

Investigative Site

Phoenix, United States, 85008-4956

Status
Completed
 
Locations

Investigative Site

Birmingham, United States, 35233

Status
Completed
 
Locations

Investigative Site

Cincinnati, United States, 45267-0769

Status
Completed
 
Locations

Investigative Site

New York, United States, 10065

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44195

Status
Completed
 
Locations

Investigative Site

Greensboro, United States, 27401

Status
Completed
 
Locations

Investigative Site

New York, United States, 10019

Status
Completed
 
Locations

Investigative Site

São José do Rio Preto, Brazil

Status
Completed
 
Locations

Investigative Site

Belo Horizonte, Brazil, 30150 221

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M5T 2S8

Status
Completed
 
Locations

Investigative Site

Barranquilla, Colombia

Status
Completed
 
Locations

Investigative Site

Cali, Colombia

Status
Completed
 
Locations

Investigative Site

Campinas, Brazil, 13060904

Status
Completed
 
Locations

Investigative Site

Brooklyn, United States, 11215

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China

Status
Completed
 
Locations

Investigative Site

Oklahoma City, United States, 73117

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43215

Status
Completed
 
Locations

Investigative Site

Mobile, United States, 36617

Status
Completed
 
Locations

Investigative Site

Muncie, United States, 47303

Status
Completed
 
Locations

Investigative Site

Charleston, United States, 29425

Status
Completed
 
Locations

Investigative Site

Danbury, United States, 06810

Status
Completed
 
Locations

Investigative Site

Las Vegas, United States, 89109

Status
Completed
 
Locations

Investigative Site

Hartford, United States, 06102

Status
Completed
 
Locations

Investigative Site

Springfield, United States, 65803

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 11217

Status
Completed
 
Locations

Investigative Site

Tainan, Taiwan, China, 710

Status
Completed
 
Locations

Investigative Site

Monterrey, Mexico, 64460

Status
Completed
 
Locations

Investigative Site

Aguascalientes, Mexico, 20000

Status
Completed
 
Locations

Investigative Site

San Luis Potosí, Mexico, 78240

Status
Completed
 
Locations

Investigative Site

Guadalajara, Mexico, 44340

Status
Completed
 
Locations

Investigative Site

México, D.F., Mexico, 07760

Status
Completed
 
Locations

Investigative Site

Blacktown, Australia, 2148

Status
Completed
 
Locations

Investigative Site

Clayton, Australia, 3168

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 137-701

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 136-705

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Investigative Site

Wollongong, Australia, 2500

Status
Completed
 
Locations

Investigative Site

Kaohsiung, Taiwan, China, 82445

Status
Completed
 
Locations

Investigative Site

Ankara, Turkey, 06100

Status
Completed
 
Locations

Investigative Site

Trabzon, Turkey, 61080

Status
Completed
 
Locations

Investigative Site

Chiang Mai, Thailand, 50200

Status
Completed
 
Locations

Investigative Site

Khon Kaen, Thailand, 40002

Status
Completed
 
Locations

Investigative Site

Newark, United States, 19713

Status
Completed
 
Locations

Investigative Site

Atlanta, United States, 30342

Status
Completed
 
Locations

Investigative Site

Youngstown, United States, 44501

Status
Completed
 
Locations

Investigative Site

Zlin, Czech Republic, 762 75

Status
Completed
 
Locations

Investigative Site

Praha 10, Czech Republic, 100 34

Status
Completed
 
Locations

Investigative Site

Barranquilla, Colombia

Status
Terminated
 
Locations

Investigative Site

Kalamazoo, United States, 49007

Status
Completed
 
Locations

Investigative Site

Quezon City, Philippines, NCR 1100

Status
Completed
 
Locations

Investigative Site

Quezon City, Philippines, 1105

Status
Completed
 
Locations

Investigative Site

Hollywood, United States, 33021-5421

Status
Completed
 
Locations

Investigative Site

Butte, United States, 59701

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44109-1998

Status
Completed
 
Locations

Investigative Site

Ottawa, Canada, K1H 8L6

Status
Completed
 
Locations

Investigative Site

Kingston, Canada

Status
Completed
 
Locations

Investigative Site

Iowa City, United States, 52242

Status
Completed
 
Locations

Investigative Site

Asheville, United States, 28801

Status
Completed
 
Locations

Investigative Site

Tampa, United States, 33606-3508

Status
Completed
 
Locations

Investigative Site

Springfield, United States, 62702

Status
Completed
 
Locations

Investigative Site

Quebec, Canada, G1V 4G5

Status
Completed
 
Locations

Investigative Site

St. Louis, United States, 63110-1093

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H1T 2M4

Status
Completed
 

Trial Design