Study Completed

Pneumonia, bacterial

Bayer Identifier:

13085

ClinicalTrials.gov Identifier:

NCT00805168

EudraCT Number:

2008-000906-35

EU CT Number:

Not Available

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

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).

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal

461

Trial Dates

April 2013 - April 2017

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Amikacin Inhalation Solution (BAY41-6551)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Withdrawn		Mannheim, 68167, Germany
Withdrawn		Regensburg, 93053, Germany
Withdrawn		Berlin, 13353, Germany
Withdrawn		Rostock, 181057, Germany
Withdrawn		Köln, 50937, Germany
Withdrawn		Hannover, 30625, Germany
Withdrawn		Berlin, 10117, Germany
Withdrawn		Southampton, SO16 6YD, United Kingdom
Withdrawn		Toulouse, 31059, France
Completed		Nimes, 30029, France
Withdrawn		Angers Cedex, 49100, France
Completed		PARIS, 75877, France
Withdrawn		Saint Michel, 16470, France
Withdrawn		Krakow, 31-826, Poland
Withdrawn		Leipzig, 04289, Germany
Withdrawn		Frankfurt, 60590, Germany
Withdrawn		Tübingen, 72076, Germany
Withdrawn		München, 81545, Germany
Withdrawn		Dresden, 01307, Germany
Withdrawn		Halle, 06112, Germany
Withdrawn		Glasgow, G42 9TY, United Kingdom
Withdrawn		Leeds, LS9 7TF, United Kingdom
Withdrawn		London, SE1 7EH, United Kingdom
Withdrawn		Winchester, SO22 5DG, United Kingdom
Completed		Paris, 75651, France
Withdrawn		Limoges, 87042, France
Withdrawn		Villefranche Sur Saône Cedex, 69655, France
Withdrawn		Paris Cedex 04, 75181, France
Withdrawn		Szczecin, 71-252, Poland
Withdrawn		Warszawa, 02-005, Poland
Withdrawn		Ota-ku, 143-8541, Japan
Withdrawn		Sagamihara, 252-0375, Japan
Withdrawn		Matsumoto, 399-0021, Japan
Completed		Nagoya, 460-0001, Japan
Completed		Osaka, 540-0006, Japan
Withdrawn		Osaka, 558-8558, Japan
Withdrawn		Sakai, 591-8555, Japan
Completed		Himeji, 670-8520, Japan
Withdrawn		Hofu, 747-8511, Japan
Completed		Nagasaki, 852-8501, Japan
Completed		Barcelona, 08036, Spain
Completed		Getafe, 28905, Spain
Completed		Poitiers, 86021, France
Withdrawn		Colombes, 92701, France
Withdrawn		Argenteuil Cedex, 95107, France
Withdrawn		VESOUL, 70014, France
Withdrawn		Poznan, 60-479, Poland
Completed		Szczecin, 70-111, Poland
Withdrawn		Poznan, 60-355, Poland
Withdrawn		Lodz, 90-549, Poland
Withdrawn		Krakow, 31-503, Poland
Withdrawn		Bydgoszcz, 85-094, Poland
Withdrawn		Morioka, 020-8505, Japan
Withdrawn		Niigata, 950-1197, Japan
Withdrawn		Niigata, 951-8520, Japan
Withdrawn		Bunkyo-ku, 113-8655, Japan
Withdrawn		Barcelona, 08035, Spain
Completed		BRUXELLES - BRUSSEL, 1090, Belgium
Withdrawn		BRUXELLES - BRUSSEL, 1070, Belgium
Completed		GENT, 9000, Belgium
Withdrawn		AMSTERDAM, 1105 AZ, Netherlands
Withdrawn		UTRECHT, 3584 CX, Netherlands
Withdrawn		Hradec Kralove, 50005, Czech Republic
Withdrawn		Brno, 62500, Czech Republic
Withdrawn		Stara Zagora, 6000, Bulgaria
Withdrawn		Plovdiv, 4002, Bulgaria
Withdrawn		Sofia, 1709, Bulgaria
Withdrawn		Sofia, 1527, Bulgaria
Withdrawn		Sofia, 1606, Bulgaria
Withdrawn		Budapest, H-1204, Hungary
Withdrawn		Bunkyo-ku, 113-8519, Japan
Completed		Maebashi, 371-8511, Japan
Completed		Seto, 489-8642, Japan
Completed		Kyoto, 607-8062, Japan
Withdrawn		Kumamoto, 860-8556, Japan
Completed		Kumamoto, 860-0008, Japan
Completed		Madrid, 28040, Spain
Withdrawn		Barcelona, 08003, Spain
Withdrawn		Alicante, 03010, Spain
Withdrawn		Badalona, 08916, Spain
Withdrawn		AMSTERDAM, 1081 HV, Netherlands
Completed		ROTTERDAM, 3083 AN, Netherlands
Withdrawn		Praha, 150 06, Czech Republic
Withdrawn		Rousse, 7000, Bulgaria
Withdrawn		Veliko Turnovo, 5000, Bulgaria
Withdrawn		Vac, 2600, Hungary
Withdrawn		Budapest, 1134, Hungary
Withdrawn		Szekesfehervar, 8000, Hungary
Completed		Kistarcsa, 2143, Hungary
Completed		Mezourlo / Larissa, Greece
Completed		Haidari, 12462, Greece
Withdrawn		Novosibirsk, 630008, Russia
Withdrawn		Novosibirsk, 630051, Russia
Withdrawn		St. Petersburg, 196247, Russia
Withdrawn		Budapest, 1115, Hungary
Withdrawn		Miskolc, 3501, Hungary
Withdrawn		Budapest, 1145, Hungary
Withdrawn		Szeged, 6720, Hungary
Completed		Heraklion, 711 10, Greece
Completed		Larissa, 41221, Greece
Withdrawn		Alexandroupolis, 68100, Greece
Completed		Smolensk, 214018, Russia
Withdrawn		Moscow, 123060, Russia
Withdrawn		Moscow, 117049, Russia
Withdrawn		Bucharest, 050098, Romania
Withdrawn		Cluj-Napoca, 400006, Romania
Withdrawn		Singapore, Singapore
Withdrawn		Singapore, 529889, Singapore
Completed		NIJMEGEN, 6525 GA, Netherlands
Withdrawn		Milano, 20162, Italy
Withdrawn		Padova, 35128, Italy
Withdrawn		Novara, 28100, Italy
Withdrawn		Pavia, 27100, Italy
Withdrawn		Bergamo, 24127, Italy
Completed		CRETEIL, 94010, France
Completed		NICE CEDEX 3, 06202, France
Withdrawn		Holon, 5810001, Israel
Completed		Petah Tikva, 4941492, Israel
Completed		Haifa, 3109601, Israel
Withdrawn		Afula, 1834111, Israel
Completed		Ramat Gan, 5262000, Israel
Completed		Tel Aviv, 64239, Israel
Completed		L'Hospitalet de Llobregat, 08907, Spain
Completed		Terrassa, 08221, Spain
Completed		Valencia, 46026, Spain
Completed		Girona, 17007, Spain
Completed		Braga, 4710-243, Portugal
Withdrawn		Porto, 4099, Portugal
Completed		Porto, 4200-072, Portugal
Withdrawn		Tübingen, 72076, Germany
Withdrawn		Hannover, 30625, Germany
Withdrawn		Aachen, 52074, Germany
Completed		Lyon, 69003, France
Completed		PARIS, 75674, France
Completed		PARIS, 75014, France
Withdrawn		Itabashi-ku, 173-8606, Japan
Completed		Nagakute, 480-1195, Japan
Withdrawn		Okayama, 700-8505, Japan
Completed		Sasebo, 857-8511, Japan
Withdrawn		Nagoya, 454-8502, Japan
Completed		Vac, 2600, Hungary
Completed		Budapest, 1121, Hungary
Completed		Budapest, 1125, Hungary
Completed		YVOIR, 5530, Belgium
Withdrawn		Bern, 3010, Switzerland
Withdrawn		Genève, 1205, Switzerland
Completed		Kyiv, 01133, Ukraine
Withdrawn		Kiev, 03110, Ukraine
Completed		Poltava, 36011, Ukraine
Withdrawn		Lugansk, 91045, Ukraine
Completed		Kharkiv, 61018, Ukraine
Completed		Yaroslavl, 150003, Russia
Completed		ANTWERPEN, 2060, Belgium
Withdrawn		Barcelona, 08035, Spain
Withdrawn		Porto, 4200-319, Portugal
Withdrawn		NANCY, 54037, France
Completed		Madrid, 28034, Spain
Completed		BRUXELLES - BRUSSEL, 1200, Belgium
Completed		Vinnitsa, 21000, Ukraine
Completed		Beijing, 100020, China
Completed		Shenyang, 110001, China
Withdrawn		Shanghai, 200080, China
Withdrawn		Beijing, 100191, China
Completed		Guangzhou, 510120, China
Withdrawn		Beijing, 100020, China
Withdrawn		Suzhou, 215006, China
Completed		Fuzhou, 350025, China
Completed		Haikou, 570311, China
Withdrawn		Beijing, 100038, China
Completed		Beiing, 100048, China
Withdrawn		Beijing, 100044, China
Completed		Beijing, 100029, China
Completed		Beijing, 100088, China
Completed		Shanghai, 200003, China
Completed		Shanghai, 200040, China
Withdrawn		Guangzhou, China
Withdrawn		Guangzhou, 510515, China
Withdrawn		Chongqing, 400038, China
Withdrawn		Chongqing, 400042, China
Completed		Chongqing, 400010, China
Completed		Nanjing, 210029, China
Completed		Hangzhou, 310016, China
Completed		Shenyang, 110004, China
Withdrawn		Chengdu, China
Completed		Xi'an, 710032, China
Withdrawn		Wuhan, 430060, China
Completed		Wuhan, 430030, China
Completed		Jinan, China
Withdrawn		Changsha, 410011, China
Withdrawn		Changsha, 410013, China
Completed		Changsha, 410008, China
Completed		Changsha, China
Withdrawn		Fuzhou, China
Completed		Yinchuan, 750004, China
Withdrawn		ENSCHEDE, 7511 JX, Netherlands
Completed		Omura, 856-8562, Japan
Completed		Matsusaka, 515-8544, Japan
Completed		Izumisano, 598-8577, Japan
Completed		Osaka, 543-0035, Japan
Completed		Nakagun, 319-1113, Japan
Withdrawn		Nanning, 530021, China
Withdrawn		Beijing, China
Completed		Shimajiri-gun, 901-1193, Japan
Completed		Xi'an, 710032, China
Completed		Xi'an, 710032, China
Withdrawn		Chongqing, 400016, China
Completed		Urumchi, 830054, China
Completed		Haikou, China
Completed		Haikou, China
Completed		Changchun, 130021, China
Withdrawn		Changchun, 130021, China
Withdrawn		Qingdao, 266000, China
Completed		Shenzhen, China
Completed		Xi'an, 710061, China
Withdrawn		Shanghai, 200032, China
Completed		Chengdu, 610041, China
Completed		Beijing, 100020, China
Withdrawn		Qingdao, 266071, China
Completed		Beijing, 100853, China
Withdrawn		Yokohama, 230-8765, Japan
Withdrawn		Fukuoka, 811-0213, Japan
Withdrawn		Onga, 807-0051, Japan
Withdrawn		Baotou, 014010, China
Completed		Shanghai, 200092, China
Completed		Beijing, 100029, China
Completed		Tianjin, 300052, China
Completed		Beijing, 100029, China
Completed		BRUXELLES - BRUSSEL, 1070, Belgium
Completed		Ota, 373-8585, Japan
Withdrawn		Hirakata, 573-1191, Japan
Withdrawn		Moscow, 117997, Russia
Withdrawn		Yekaterinburg, 620109, Russia
Completed		Yekaterinburg, 620102, Russia
Completed		Mineola, 10065, United States
Completed		Miami, 33125, United States
Completed		Hazard, 41701, United States
Completed		Phoenix, 85008-4956, United States
Withdrawn		New York, 10029, United States
Completed		Birmingham, 35233, United States
Completed		Cincinnati, 45267-0769, United States
Withdrawn		Chicago, 60612, United States
Withdrawn		Chicago, 60611, United States
Completed		New York, 10065, United States
Withdrawn		Grand Blanc, 48439, United States
Withdrawn		Johnson City, 13790, United States
Completed		Cleveland, 44195, United States
Withdrawn		Charleston, 25304, United States
Completed		Greensboro, 27401, United States
Withdrawn		Porto Alegre, 90610-000, Brazil
Completed		New York, 10019, United States
Withdrawn		Memphis, 38163, United States
Completed		São José do Rio Preto, Brazil
Withdrawn		Porto Alegre, 90880-480, Brazil
Withdrawn		Lima, Peru
Withdrawn		Lima, LIMA 11, Peru
Withdrawn		Buenos Aires [Capital Federal], 1120, Argentina
Withdrawn		Porto Alegre, 90035-074, Brazil
Withdrawn		Porto Alegre, 90450 130, Brazil
Completed		Belo Horizonte, 30150 221, Brazil
Withdrawn		Curitiba, 80440-080, Brazil
Withdrawn		Lima, 31, Peru
Withdrawn		Lima, LIMA 1, Peru
Withdrawn		Sherbrooke, J1H 5N4, Canada
Completed		Toronto, M5T 2S8, Canada
Completed		Barranquilla, Colombia
Withdrawn		Houston, 77030, United States
Withdrawn		Englewood, 07631, United States
Withdrawn		Bogotá, Colombia
Withdrawn		Bogotá, Colombia
Completed		Cali, Colombia
Withdrawn		Sao Paulo, 04012-000, Brazil
Completed		Campinas, 13060904, Brazil
Completed		Brooklyn, 11215, United States
Withdrawn		Farmington, 06030, United States
Withdrawn		Sarasota, 34232, United States
Completed		Taipei, Taiwan
Completed		Oklahoma City, 73117, United States
Completed		Columbus, 43215, United States
Completed		Mobile, 36617, United States
Withdrawn		Knoxville, 37920, United States
Withdrawn		Augusta, 30909, United States
Completed		Muncie, 47303, United States
Completed		Charleston, 29425, United States
Completed		Danbury, 06810, United States
Completed		Las Vegas, 89109, United States
Completed		Hartford, 06102, United States
Withdrawn		San Antonio, 78229, United States
Completed		Springfield, 65803, United States
Withdrawn		Detroit, 48202, United States
Completed		Taipei, 11217, Taiwan
Completed		Tainan, 710, Taiwan
Withdrawn		Kaoshiung, 81346, Taiwan
Withdrawn		Hermosillo, 83000, Mexico
Completed		Monterrey, 64460, Mexico
Withdrawn		México D.F., 14080, Mexico
Withdrawn		Chihuahua, Chih., 31000, Mexico
Completed		Aguascalientes, 20000, Mexico
Completed		San Luis Potosí, 78240, Mexico
Completed		Guadalajara, 44340, Mexico
Withdrawn		Toluca, 50130, Mexico
Completed		México, D.F., 07760, Mexico
Completed		Blacktown, 2148, Australia
Withdrawn		Herston, 4029, Australia
Withdrawn		Footscray, 3011, Australia
Withdrawn		Richmond, 3122, Australia
Completed		Clayton, 3168, Australia
Withdrawn		Parkville, 3050, Australia
Withdrawn		Hobart, 7000, Australia
Completed		Seoul, 137-701, Korea, Republic Of
Withdrawn		Seoul, 152-703, Korea, Republic Of
Completed		Seoul, 136-705, Korea, Republic Of
Completed		Seoul, 138-736, Korea, Republic Of
Withdrawn		Wonju-si, 220-701, Korea, Republic Of
Withdrawn		Herston, 4029, Australia
Completed		Wollongong, 2500, Australia
Completed		Kaohsiung, 82445, Taiwan
Withdrawn		Stanford, 94305, United States
Withdrawn		Incheon, 21565, Korea, Republic Of
Completed		Ankara, 06100, Turkey
Withdrawn		Ankara, 06500, Turkey
Withdrawn		Istanbul, 34160, Turkey
Completed		Trabzon, 61080, Turkey
Withdrawn		Istanbul, 34-300, Turkey
Withdrawn		Izmir, 35040, Turkey
Withdrawn		Seoul, 120-752, Korea, Republic Of
Completed		Chiang Mai, 50200, Thailand
Completed		Khon Kaen, 40002, Thailand
Withdrawn		Portland, 04102, United States
Completed		Newark, 19713, United States
Withdrawn		Baltimore, 21201, United States
Withdrawn		San Diego, 92103-8896, United States
Completed		Atlanta, 30342, United States
Withdrawn		Miami, 33136, United States
Completed		Youngstown, 44501, United States
Withdrawn		Hradec Kralove, 500 05, Czech Republic
Withdrawn		Praha 5, 150 06, Czech Republic
Completed		Zlin, 762 75, Czech Republic
Completed		Praha 10, 100 34, Czech Republic
Withdrawn		Usti nad Labem, 401 13, Czech Republic
Withdrawn		Córdoba, 5000, Argentina
Withdrawn		Mendoza, 5500, Argentina
Withdrawn		Cordoba, 5000, Argentina
Withdrawn		Merlo, B1712FJN, Argentina
Withdrawn		Buenos Aires, C1181ACH, Argentina
Terminated		Barranquilla, Colombia
Withdrawn		Bogotá, Colombia
Withdrawn		Guadalajara, 44280, Mexico
Withdrawn		San Antonio, 78229-3900, United States
Withdrawn		Buffalo, 14215, United States
Withdrawn		Jacksonville, 32209, United States
Withdrawn		Denver, 80204, United States
Completed		Kalamazoo, 49007, United States
Withdrawn		Manila, Philippines
Completed		Quezon City, NCR 1100, Philippines
Completed		Quezon City, 1105, Philippines
Completed		Hollywood, 33021-5421, United States
Completed		Butte, 59701, United States
Completed		Cleveland, 44109-1998, United States
Withdrawn		Royal Oak, 48073, United States
Withdrawn		Adelaide, 5011, Australia
Completed		Ottawa, K1H 8L6, Canada
Completed		Kingston, Canada
Completed		Iowa City, 52242, United States
Withdrawn		Nashville, 37212, United States
Completed		Asheville, 28801, United States
Completed		Tampa, 33606-3508, United States
Withdrawn		Peoria, 61606, United States
Withdrawn		Indianapolis, 46202, United States
Withdrawn		Chicago, 60612, United States
Withdrawn		Middletown, 45005, United States
Completed		Springfield, 62702, United States
Completed		Quebec, G1V 4G5, Canada
Completed		St. Louis, 63110-1093, United States
Withdrawn		Ann Arbor, 48109-0330, United States
Completed		Montreal, H1T 2M4, Canada
Completed		New York, 10065, United States

Primary Outcome

Number of Participants Surviving Through LFU Visit
The primary efficacy variable is Survival through the late follow-up (LFU) visit. Survival is achieved when the participant is alive through the LFU visit. No other factors are considered in the evaluation of survival.
Time Frame:
Up to 28-32 days after start of study treatment

Secondary Outcome

Number of Adjudicated Pneumonia-Related Death Through LFU Visit
Death through LFU visit was adjudicated as pneumonia-related or pneumonia-unrelated for participants in the amikacin inhale group and participants in the placebo group.
Time Frame:
Up to 28-32 days after start of study treatment
Number of Participants with Early Clinical Response
Early Clinical Response was determined by the following: 1. CPIS scoring at Days 3, 5, and 10 compared to baseline (a. On Day 3, CPIS increase from baseline by at least 2 points was considered a failure. b. On Day 5, CPIS decrease from baseline of at least 1 point was not a failure. CPIS of no change from baseline was considered a failure. Any CPIS increase from baseline was a failure. c. On Day 10, CPIS decrease from baseline of at least 2 points was not a failure. CPIS decrease of only 1 point is a failure. Clinical Pulmonary Infection Score of no change was considered a failure. Any CPIS increase from baseline was a failure). 2. All-cause mortality through EOT visit was a failure. 3. The development of empyema or lung abscess through the EOT visit was a failure.
Time Frame:
Up to 10 days after start of study treatment
Number of Days on Mechanical Ventilation Through LFU Visit
Number of days on mechanical ventilator was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived through the LFU visit, the ventilation days were actual days on ventilation with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days on ventilator was censored at 28 days. For participants who died or discontinued off ventilation, the number of days on ventilation was actual days on ventilation with a maximum value of 28 days. For participants who died or discontinued on ventilation, the number of days on ventilation was 28 days. Further analysis of the number of days on mechanical ventilator was to be performed with censoring at Day 28 for subset of participants on ventilation without censoring.
Time Frame:
Up to 28-32 days after start of study treatment
Number of Days in the ICU Through LFU Visit
Number of days in ICU was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived in ICU through the LFU visit, the ICU days were actual days in ICU with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days in ICU was censored at 28 days. For participants who died or discontinued in ICU, the number of days in ICU was 28 days. Further analysis of the number of days in ICU was to be performed with censoring at Day 28 for subset of participants on ventilation and without censoring.
Time Frame:
Up to 28-32 days after start of study treatment

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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