Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia (INHALE 2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Bayer
Sponsor:
Collaborators:
Nektar Therapeutics
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00805168
First received: December 8, 2008
Last updated: August 3, 2015
Last verified: August 2015
  Purpose

To evaluate the efficacy and safety of adjunctive aerosolized BAY 41-6551 (amikacin inhalation solution) versus aerosolized placebo in the treatment of intubated and mechanically ventilated adult patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics


Condition Intervention Phase
Pneumonia, Bacterial
Drug: Amikacin Inhalation Solution (BAY41-6551)
Drug: Aerosolized Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Proportion of cured patients in the BAY41-6551 group divided by the proportion of cured patients in the placebo group [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of days on mechanical ventilation through the Day 28 visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Number of intensive care unit (ICU) days at the Day 28 visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Number of days in the hospital [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Relapse rates [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Per patient microbiological response rates at the Test Of Cure (TOC) visit [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Microbiological recurrence rates at the TOC and Day 28 Visit [ Time Frame: 17-19 days and then 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Emergence of new potential respiratory pathogens during the treatment period. [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Emergence of resistance among baseline pathogens in those patients with persistent infection or colonization [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Number of patients who have received at least one dose of study drug and reported an adverse event [ Time Frame: After patient has signed Informed Consent until they have ended participation on the Study ] [ Designated as safety issue: Yes ]
  • Mortality during the treatment period, Day 15, and Day 28 visit [ Time Frame: 17-19 days and then 28-32 days after start of treatment with study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 650
Study Start Date: May 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Amikacin Inhalation Solution (BAY41-6551)
400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
Placebo Comparator: Arm 2 Drug: Aerosolized Placebo
Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 or at least two risk factors for multi-drug resistant 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805168

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Hide Study Locations
Locations
Belgium
Recruiting
Antwerpen, Belgium, 2060
Not yet recruiting
Bruxelles - Brussel, Belgium, 1070
Recruiting
Bruxelles - Brussel, Belgium, 1090
Recruiting
Bruxelles - Brussel, Belgium, 1200
Not yet recruiting
Gent, Belgium, 9000
Recruiting
Yvoir, Belgium, 5530
Bulgaria
Not yet recruiting
Plovdiv, Bulgaria, 4002
Not yet recruiting
Rousse, Bulgaria, 7000
Not yet recruiting
Sofia, Bulgaria, 1527
Not yet recruiting
Sofia, Bulgaria, 1606
Not yet recruiting
Sofia, Bulgaria, 1709
Not yet recruiting
Stara Zagora, Bulgaria, 6000
Not yet recruiting
Veliko Turnovo, Bulgaria, 5000
China, Fujian
Not yet recruiting
Fuzhou, Fujian, China
China, Guangdong
Recruiting
Guangzhou, Guangdong, China, 510120
Terminated
Guangzhou, Guangdong, China, 510515
Terminated
Guangzhou, Guangdong, China
Recruiting
Shenzhen, Guangdong, China
China, Guangxi
Not yet recruiting
Nanning, Guangxi, China, 530021
China, Hainan
Recruiting
Haikou, Hainan, China, 570311
Recruiting
Haikou, Hainan, China
China, Hubei
Not yet recruiting
Wuhan, Hubei, China, 430030
Terminated
Wuhan, Hubei, China, 430060
China, Hunan
Not yet recruiting
Changsha, Hunan, China, 410013
Terminated
Changsha, Hunan, China, 410011
Recruiting
Changsha, Hunan, China, 410008
China, Inner Mongolia
Not yet recruiting
Baotou, Inner Mongolia, China, 014010
China, Jiangsu
Recruiting
Nanjing, Jiangsu, China, 210029
Not yet recruiting
Suzhou, Jiangsu, China, 215006
China, Jilin
Not yet recruiting
Changchun, Jilin, China
Recruiting
Changchun, Jilin, China
China, Liaoning
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Shenyang, Liaoning, China, 11000
Recruiting
Shenyang, Liaoning, China, 110004
China, Ningxia
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Yinchuan, Ningxia, China
China, Shaanxi
Recruiting
Xi'an, Shaanxi, China, 710032
Recruiting
Xi'an, Shaanxi, China, 710061
China, Shandong
Not yet recruiting
Jinan, Shandong, China
Not yet recruiting
Qingdao, Shandong, China, 266100
China, Sichuan
Terminated
Chengdu, Sichuan, China
Recruiting
Chengdu, Sichuan, China, 610041
China, Xinjiang
Not yet recruiting
Urumchi, Xinjiang, China
China, Zhejiang
Recruiting
Hangzhou, Zhejiang, China, 310016
China
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Beiing, China
Recruiting
Beijing, China, 100020
Terminated
Beijing, China, 100020
Not yet recruiting
Beijing, China
Recruiting
Beijing, China, 100029
Not yet recruiting
Beijing, China, 100029
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Beijing, China, 100038
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Beijing, China, 100044
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Beijing, China, 100083
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Beijing, China, 100088
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Beijing, China, 100853
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Beijing, China, 100020
Recruiting
Changsha, China
Recruiting
Chongqing, China, 400010
Not yet recruiting
Chongqing, China, 400016
Not yet recruiting
Chongqing, China, 400038
Terminated
Chongqing, China, 400042
Recruiting
Fuzhou, China, 350025
Not yet recruiting
Qingdao, China, 266071
Not yet recruiting
Shanghai, China, 200003
Not yet recruiting
Shanghai, China, 200032
Recruiting
Shanghai, China, 200040
Terminated
Shanghai, China, 200080
Not yet recruiting
Shanghai, China
Not yet recruiting
Tianjin, China, 300052
Czech Republic
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Brno, Czech Republic, 62500
Not yet recruiting
Hradec Kralove, Czech Republic, 50005
Not yet recruiting
Praha, Czech Republic, 150 06
France
Terminated
Angers Cedex, France, 49100
Terminated
Argenteuil Cedex, France, 95107
Terminated
Colombes, France, 92701
Not yet recruiting
Creteil, France, 94010
Terminated
Limoges, France, 87042
Recruiting
Lyon, France, 69003
Terminated
Lyon, France, 69003
Recruiting
Nice, France, 06002
Recruiting
Nimes, France, 30029
Recruiting
Paris, France, 75674
Recruiting
Paris, France, 75014
Recruiting
Paris, France, 75651
Recruiting
Paris, France, 75877
Terminated
Paris Cedex 04, France, 75181
Recruiting
Poitiers, France, 86021
Terminated
Saint Michel, France, 16470
Terminated
Toulouse, France, 31059
Terminated
Vesoul, France, 70014
Terminated
Villefranche Sur Saône Cedex, France, 69655
Germany
Terminated
Mannheim, Baden-Württemberg, Germany, 68167
Terminated
Tübingen, Baden-Württemberg, Germany, 72076
Not yet recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Terminated
München, Bayern, Germany, 81545
Terminated
Regensburg, Bayern, Germany, 93053
Terminated
Frankfurt, Hessen, Germany, 60590
Terminated
Rostock, Mecklenburg-Vorpommern, Germany, 181057
Not yet recruiting
Hannover, Niedersachsen, Germany, 30625
Not yet recruiting
Aachen, Nordrhein-Westfalen, Germany, 52074
Not yet recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Terminated
Halle, Sachsen-Anhalt, Germany, 06112
Not yet recruiting
Dresden, Sachsen, Germany, 01307
Terminated
Leipzig, Sachsen, Germany, 04289
Terminated
Berlin, Germany, 13353
Terminated
Berlin, Germany, 10117
Greece
Recruiting
Haidari, Attica, Greece, 12462
Not yet recruiting
Alexandroupolis, Greece, 68100
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Heraklion, Greece, 711 10
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Larissa, Greece, 41221
Recruiting
Mezourlo / Larissa, Greece
Hungary
Terminated
Budapest, Hungary, 1115
Recruiting
Budapest, Hungary, 1121
Terminated
Budapest, Hungary, H-1204
Terminated
Budapest, Hungary, 1145
Recruiting
Budapest, Hungary, H-1125
Not yet recruiting
Budapest, Hungary, 1134
Recruiting
Kistarcsa, Hungary, 2143
Terminated
Miskolc, Hungary, 3501
Terminated
Szeged, Hungary, 6720
Not yet recruiting
Szekesfehervar, Hungary, 8000
Terminated
Vac, Hungary, 2600
Recruiting
Vac, Hungary, 2600
Israel
Not yet recruiting
Afula, Israel, 1834111
Not yet recruiting
Haifa, Israel, 3109601
Not yet recruiting
Holon, Israel, 5810001
Recruiting
Petach Tikva, Israel, 4941492
Recruiting
Tel Aviv, Israel, 64239
Recruiting
Tel Hashomer, Israel, 5262000
Italy
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Bergamo, Italy, 24127
Not yet recruiting
Milano, Italy, 20162
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Novara, Italy, 28100
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Padova, Italy, 35128
Not yet recruiting
Pavia, Italy, 27100
Japan
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Nagakute, Aichi, Japan, 480-1195
Not yet recruiting
Nagoya, Aichi, Japan, 460-0001
Terminated
Nagoya, Aichi, Japan, 454-8502
Recruiting
Seto, Aichi, Japan, 489-8642
Not yet recruiting
Onga, Fukuoka, Japan, 807-0051
Recruiting
Maebashi, Gunma, Japan, 371-8511
Recruiting
Himeji, Hyogo, Japan, 670-8520
Recruiting
Nakagun, Ibaraki, Japan, 319-1113
Not yet recruiting
Morioka, Iwate, Japan, 020-8505
Terminated
Sagamihara, Kanagawa, Japan, 252-0375
Terminated
Yokohama, Kanagawa, Japan, 230-8765
Recruiting
Matsusaka, Mie, Japan, 515-8544
Terminated
Matsumoto, Nagano, Japan, 399-0021
Recruiting
Omura, Nagasaki, Japan, 856-8562
Not yet recruiting
Sasebo, Nagasaki, Japan, 857-8511
Not yet recruiting
Shimajiri-gun, Okinawa, Japan, 901-1193
Recruiting
Izumisano, Osaka, Japan, 598-8577
Terminated
Sakai, Osaka, Japan, 591-8555
Terminated
Bunkyo-ku, Tokyo, Japan, 113-8655
Not yet recruiting
Bunkyo-ku, Tokyo, Japan, 113-8519
Terminated
Itabashi-ku, Tokyo, Japan, 173-8606
Terminated
Ota-ku, Tokyo, Japan, 143-8541
Terminated
Hofu, Yamaguchi, Japan, 747-8511
Not yet recruiting
Fukuoka, Japan, 811-0213
Not yet recruiting
Kumamoto, Japan, 860-8556
Recruiting
Kumamoto, Japan, 860-0008
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Kyoto, Japan, 607-8062
Recruiting
Nagasaki, Japan, 852-8501
Not yet recruiting
Niigata, Japan, 950-1197
Not yet recruiting
Niigata, Japan, 951-8520
Not yet recruiting
Okayama, Japan, 700-8505
Recruiting
Osaka, Japan, 540-0006
Not yet recruiting
Osaka, Japan, 543-0035
Terminated
Osaka, Japan, 558-8558
Netherlands
Terminated
Amsterdam, Netherlands, 1105 AZ
Terminated
Amsterdam, Netherlands, 1081 HV
Not yet recruiting
Enschede, Netherlands, 7511 JX
Recruiting
Nijmegen, Netherlands, 6525 GA
Not yet recruiting
Rotterdam, Netherlands, 3083 AN
Terminated
Utrecht, Netherlands, 3584 CX
Poland
Terminated
Bydgoszcz, Poland, 85-094
Terminated
Krakow, Poland, 31-503
Terminated
Krakow, Poland, 31-826
Terminated
Lodz, Poland, 90-549
Terminated
Poznan, Poland, 60-355
Terminated
Poznan, Poland, 60-479
Recruiting
Szczecin, Poland, 70-111
Terminated
Szczecin, Poland, 71-252
Terminated
Warszawa, Poland, 02-005
Portugal
Not yet recruiting
Braga, Portugal, 4710-243
Not yet recruiting
Porto, Portugal, 4099
Recruiting
Porto, Portugal, 4200-072
Not yet recruiting
Porto, Portugal, 4200-319
Romania
Not yet recruiting
Bucharest, Romania, 050098
Not yet recruiting
Cluj-Napoca, Romania, 400006
Russian Federation
Terminated
Moscow, Russian Federation, 117049
Terminated
Moscow, Russian Federation, 123060
Terminated
Novosibirsk, Russian Federation, 630008
Terminated
Novosibirsk, Russian Federation, 630051
Recruiting
Smolensk, Russian Federation, 214018
Terminated
St. Petersburg, Russian Federation, 196247
Recruiting
Yaroslavl, Russian Federation, 150003
Singapore
Not yet recruiting
Singapore, Singapore, 529889
Not yet recruiting
Singapore, Singapore
Spain
Terminated
Badalona, Barcelona, Spain, 08916
Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Recruiting
Terrassa, Barcelona, Spain, 08221
Terminated
Barcelona, Catalunya, Spain, 08003
Recruiting
Getafe, Madrid, Spain, 28905
Terminated
Alicante, Spain, 03010
Recruiting
Barcelona, Spain, 08036
Not yet recruiting
Barcelona, Spain, 08035
Terminated
Barcelona, Spain, 08035
Recruiting
Girona, Spain, 17007
Recruiting
Madrid, Spain, 28034
Not yet recruiting
Madrid, Spain, 28040
Recruiting
Valencia, Spain, 46026
Switzerland
Not yet recruiting
Bern, Switzerland, 3010
Not yet recruiting
Genève, Switzerland, 1211
Ukraine
Not yet recruiting
Kharkiv, Ukraine, 61018
Not yet recruiting
Kiev, Ukraine, 03110
Not yet recruiting
Kyiv, Ukraine, 01133
Not yet recruiting
Lugansk, Ukraine, 91045
Not yet recruiting
Poltava, Ukraine, 36011
Not yet recruiting
Vinnitsa, Ukraine, 21000
United Kingdom
Not yet recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Not yet recruiting
Glasgow, United Kingdom, G42 9TY
Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Not yet recruiting
London, United Kingdom, SE1 7EH
Not yet recruiting
Winchester, United Kingdom, SO22 5DG
Sponsors and Collaborators
Bayer
Nektar Therapeutics
Novartis Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00805168     History of Changes
Other Study ID Numbers: 13085, 2008-000906-35
Study First Received: December 8, 2008
Last Updated: August 3, 2015
Health Authority: Belgium: Institutional Review Board
Germany: Ethics Commission
France: Ministry of Health
Spain: Ministry of Health
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Netherlands: Medical Ethics Review Committee (METC)
Norway: Norwegian Medicines Agency (Statens legemiddelverk, NOMA)Russia: Ethics Committee
Ukraine: Ministry of Health
China: Ministry of Health
Greece: Ethics Committee
Israel: Ministry of Health
Japan: Institutional Review Board
Portugal: The National Institute of Pharmacy and Medicines (Infarmed)

Keywords provided by Bayer:
Gram-negative Pneumonia
Pneumonia
Intubation
Mechanical ventilation
Amikacin

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 03, 2015