check_circleStudy Completed
Pneumonia, bacterial
Bayer Identifier:
13085
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
461Trial Dates
April 2013 - April 2017Phase
Phase 3Could I Receive a placebo
YesProducts
Amikacin Inhalation Solution (BAY41-6551)Accepts Healthy Volunteer
NoWhere 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Withdrawn | Mannheim, 68167, Germany | |
Withdrawn | Regensburg, 93053, Germany | |
Withdrawn | Berlin, 13353, Germany | |
Withdrawn | Rostock, 181057, Germany | |
Withdrawn | Köln, 50937, Germany | |
Withdrawn | Hannover, 30625, Germany | |
Withdrawn | Berlin, 10117, Germany | |
Withdrawn | Southampton, SO16 6YD, United Kingdom | |
Withdrawn | Toulouse, 31059, France | |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Withdrawn | Angers Cedex, 49100, France | |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Withdrawn | Saint Michel, 16470, France | |
Withdrawn | Krakow, 31-826, Poland | |
Withdrawn | Leipzig, 04289, Germany | |
Withdrawn | Frankfurt, 60590, Germany | |
Withdrawn | Tübingen, 72076, Germany | |
Withdrawn | München, 81545, Germany | |
Withdrawn | Dresden, 01307, Germany | |
Withdrawn | Halle, 06112, Germany | |
Withdrawn | Glasgow, G42 9TY, United Kingdom | |
Withdrawn | Leeds, LS9 7TF, United Kingdom | |
Withdrawn | London, SE1 7EH, United Kingdom | |
Withdrawn | Winchester, SO22 5DG, United Kingdom | |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Withdrawn | Limoges, 87042, France | |
Withdrawn | Villefranche Sur Saône Cedex, 69655, France | |
Withdrawn | Paris Cedex 04, 75181, France | |
Withdrawn | Szczecin, 71-252, Poland | |
Withdrawn | Warszawa, 02-005, Poland | |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 VisitThe 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.date_rangeTime Frame:Up to 28-32 days after start of study treatment
Secondary Outcome
- Number of Adjudicated Pneumonia-Related Death Through LFU VisitDeath through LFU visit was adjudicated as pneumonia-related or pneumonia-unrelated for participants in the amikacin inhale group and participants in the placebo group.date_rangeTime Frame:Up to 28-32 days after start of study treatment
- Number of Participants with Early Clinical ResponseEarly 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.date_rangeTime Frame:Up to 10 days after start of study treatment
- Number of Days on Mechanical Ventilation Through LFU VisitNumber 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.date_rangeTime Frame:Up to 28-32 days after start of study treatment
- Number of Days in the ICU Through LFU VisitNumber 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.date_rangeTime Frame:Up to 28-32 days after start of study treatment
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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