Trial Condition(s):

Pneumonia, Bacterial

Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the treatment of Gram-Negative Pneumonia (INHALE 2)

Bayer Identifier:

13085

ClinicalTrials.gov Identifier:

NCT00805168

EudraCT Number:

2008-000906-35

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 specimen, 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 umol/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
461
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

Nimes, France, 30029

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75877

Status
Completed
 
Locations

Investigative Site

Paris, France, 75651

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 460-0001

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 540-0006

Status
Completed
 
Locations

Investigative Site

Himeji, Japan, 670-8520

Status
Completed
 
Locations

Investigative Site

Nagasaki, Japan, 852-8501

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Getafe, Spain, 28905

Status
Completed
 
Locations

Investigative Site

Poitiers, France, 86021

Status
Completed
 
Locations

Investigative Site

Szczecin, Poland, 70-111

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1090

Status
Completed
 
Locations

Investigative Site

GENT, Belgium, 9000

Status
Completed
 
Locations

Investigative Site

Maebashi, Japan, 371-8511

Status
Completed
 
Locations

Investigative Site

Seto, Japan, 489-8642

Status
Completed
 
Locations

Investigative Site

Kyoto, Japan, 607-8062

Status
Completed
 
Locations

Investigative Site

Kumamoto, Japan, 860-0008

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28040

Status
Completed
 
Locations

Investigative Site

ROTTERDAM, Netherlands, 3083 AN

Status
Completed
 
Locations

Investigative Site

Kistarcsa, Hungary, 2143

Status
Completed
 
Locations

Investigative Site

Mezourlo / Larissa, Greece

Status
Completed
 
Locations

Investigative Site

Haidari, Greece, 12462

Status
Completed
 
Locations

Investigative Site

Heraklion, Greece, 711 10

Status
Completed
 
Locations

Investigative Site

Larissa, Greece, 41221

Status
Completed
 
Locations

Investigative Site

Smolensk, Russia, 214018

Status
Completed
 
Locations

Investigative Site

NIJMEGEN, Netherlands, 6525 GA

Status
Completed
 
Locations

Investigative Site

CRETEIL, France, 94010

Status
Completed
 
Locations

Investigative Site

NICE CEDEX 3, France, 06202

Status
Completed
 
Locations

Investigative Site

Petah Tikva, Israel, 4941492

Status
Completed
 
Locations

Investigative Site

Haifa, Israel, 3109601

Status
Completed
 
Locations

Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

Investigative Site

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Investigative Site

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Investigative Site

Terrassa, Spain, 08221

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46026

Status
Completed
 
Locations

Investigative Site

Girona, Spain, 17007

Status
Completed
 
Locations

Investigative Site

Braga, Portugal, 4710-243

Status
Completed
 
Locations

Investigative Site

Porto, Portugal, 4200-072

Status
Completed
 
Locations

Investigative Site

Lyon, France, 69003

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75674

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75014

Status
Completed
 
Locations

Investigative Site

Nagakute, Japan, 480-1195

Status
Completed
 
Locations

Investigative Site

Sasebo, Japan, 857-8511

Status
Completed
 
Locations

Investigative Site

Vac, Hungary, 2600

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1121

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1125

Status
Completed
 
Locations

Investigative Site

YVOIR, Belgium, 5530

Status
Completed
 
Locations

Investigative Site

Kyiv, Ukraine, 01133

Status
Completed
 
Locations

Investigative Site

Poltava, Ukraine, 36011

Status
Completed
 
Locations

Investigative Site

Kharkiv, Ukraine, 61018

Status
Completed
 
Locations

Investigative Site

Yaroslavl, Russia, 150003

Status
Completed
 
Locations

Investigative Site

ANTWERPEN, Belgium, 2060

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28034

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Investigative Site

Vinnitsa, Ukraine, 21000

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100020

Status
Completed
 
Locations

Investigative Site

Shenyang, China, 110001

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510120

Status
Completed
 
Locations

Investigative Site

Fuzhou, China, 350025

Status
Completed
 
Locations

Investigative Site

Haikou, China, 570311

Status
Completed
 
Locations

Investigative Site

Beiing, China, 100048

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100029

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100088

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200003

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200040

Status
Completed
 
Locations

Investigative Site

Chongqing, China, 400010

Status
Completed
 
Locations

Investigative Site

Nanjing, China, 210029

Status
Completed
 
Locations

Investigative Site

Hangzhou, China, 310016

Status
Completed
 
Locations

Investigative Site

Shenyang, China, 110004

Status
Completed
 
Locations

Investigative Site

Xi'an, China, 710032

Status
Completed
 
Locations

Investigative Site

Wuhan, China, 430030

Status
Completed
 
Locations

Investigative Site

Jinan, China

Status
Completed
 
Locations

Investigative Site

Changsha, China, 410008

Status
Completed
 
Locations

Investigative Site

Changsha, China

Status
Completed
 
Locations

Investigative Site

Yinchuan, China, 750004

Status
Completed
 
Locations

Investigative Site

Omura, Japan, 856-8562

Status
Completed
 
Locations

Investigative Site

Matsusaka, Japan, 515-8544

Status
Completed
 
Locations

Investigative Site

Izumisano, Japan, 598-8577

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 543-0035

Status
Completed
 
Locations

Investigative Site

Nakagun, Japan, 319-1113

Status
Completed
 
Locations

Investigative Site

Shimajiri-gun, Japan, 901-1193

Status
Completed
 
Locations

Investigative Site

Urumchi, China, 830054

Status
Completed
 
Locations

Investigative Site

Haikou, China

Status
Completed
 
Locations

Investigative Site

Changchun, China, 130021

Status
Completed
 
Locations

Investigative Site

Shenzhen, China

Status
Completed
 
Locations

Investigative Site

Xi'an, China, 710061

Status
Completed
 
Locations

Investigative Site

Chengdu, China, 610041

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100853

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200092

Status
Completed
 
Locations

Investigative Site

Tianjin, China, 300052

Status
Completed
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

Ota, Japan, 373-8585

Status
Completed
 
Locations

Investigative Site

Yekaterinburg, Russia, 620102

Status
Completed
 
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