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 2014 by Bayer
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00805168
First received: December 8, 2008
Last updated: August 6, 2014
Last verified: August 2014
  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:
  • Clinical response at the Test-of-Cure (TOC) visit in the modified Intent-to-Treat (ie, ITT population plus a pre-therapy culture positive for a Gram-negative respiratory tract pathogen and an APACHE II score of at least 10) population. [ 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 ]
  • Total number of days of Gram-negative IV antibiotics per patient [ Time Frame: 17-19 days and then 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 hospital days at the Day 28 visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Clinical relapse rates at the Day 28 visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Per pathogen microbiological response rates at the TOC visit [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Per patient microbiological response rates at the 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 pneumonia- 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
  • Signs of infection
  • Impaired oxygenation
  • CPIS of at least 6
  • 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 24 hours at the time of randomization
  • Primary lung cancer (including patients with small cell lung carcinoma/non-small cell lung carcinoma and patients with unknown histology) or another malignancy metastatic to the lungs or other known endobronchial obstructions Exception: Please note that patients with complete resection of non-small cell lung carcinoma are eligible for the study.
  • Known or suspected active tuberculosis, cystic fibrosis, human immunodeficiency virus (HIV) infection with CD 4 count < 200 cell/mm3, or invasive fungal infection of the lung, lung abscess, or empyema
  • Known or suspected bacteremia secondary to Staphylococcus aureus
  • Has had a stroke within five days
  • A positive urine and/or serum beta-hCG pregnancy test
  • Burns greater than 40% of total body surface area
  • 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 (CVVH and CVVH-D) or daily hemodialysis will receive the aerosol study drug treatment
  • Neutropenia (Screening ANC < 103 neutrophils/mm3), stem cell transplant
  • 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 VAP that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
  • Stem cell transplantation
  • Patients with documented Legionella infection (eg, Legionella pneumonia)
  • Has an APACHE II score < 10
  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, 1090
Not yet recruiting
Bruxelles - Brussel, Belgium, 1070
Not yet recruiting
Bruxelles - Brussel, Belgium, 1200
Recruiting
Yvoir, Belgium, 5530
Bulgaria
Not yet recruiting
Plovdiv, Bulgaria, 4002
Not yet recruiting
Rousse, Bulgaria, 7000
Not yet recruiting
Sofia, Bulgaria, 1709
Not yet recruiting
Sofia, Bulgaria, 1527
Not yet recruiting
Sofia, Bulgaria, 1606
Not yet recruiting
Stara Zagora, Bulgaria, 6000
Not yet recruiting
Veliko Turnovo, Bulgaria, 5000
China, Fujian
Not yet recruiting
Fuzhou, Fujian, China
China, Guangdong
Terminated
Guangzhou, Guangdong, China
Terminated
Guangzhou, Guangdong, China, 510515
Not yet recruiting
Guangzhou, Guangdong, China, 510120
Not yet recruiting
Shenzhen, Guangdong, China
China, Guangxi
Not yet recruiting
Nanning, Guangxi, China, 530021
China, Hainan
Not yet recruiting
Haikou, Hainan, China, 570311
Not yet recruiting
Haikou, Hainan, China
Recruiting
Haikou, Hainan, China
China, Hubei
Not yet recruiting
Wuhan, Hubei, China, 430030
Terminated
Wuhan, Hubei, China, 430060
China, Hunan
Terminated
Changsha, Hunan, China, 410011
Not yet recruiting
Changsha, Hunan, China, 410008
Not yet recruiting
Changsha, Hunan, China, 410013
China, Jiangsu
Not yet recruiting
Nanjing, Jiangsu, China, 210029
Not yet recruiting
Suzhou, Jiangsu, China, 215006
China, Jilin
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Changchun, Jilin, China
China, Liaoning
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Shenyang, Liaoning, China, 110004
China, Ningxia
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Yinchuan, Ningxia, China
China, Shaanxi
Not yet recruiting
Xi'an, Shaanxi, China, 710032
Recruiting
Xi'an, Shaanxi, China, 710032
Not yet 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
Not yet recruiting
Chengdu, Sichuan, China, 610041
China, Xinjiang
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Urumchi, Xinjiang, China
China, Zhejiang
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Hangzhou, Zhejiang, China, 310016
China
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Beiing, China
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Beijing, China, 100020
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Beijing, China
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Beijing, China, 100038
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Beijing, China, 100083
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Beijing, China, 100029
Not yet recruiting
Beijing, China, 100088
Not yet recruiting
Beijing, China, 100853
Terminated
Beijing, China, 100020
Not yet recruiting
Beijing, China, 100044
Not yet recruiting
Changsha, China
Not yet recruiting
Chongqing, China, 400038
Not yet recruiting
Chongqing, China, 400010
Not yet recruiting
Chongqing, China, 400016
Terminated
Chongqing, China, 400042
Not yet recruiting
Fuzhou, China, 350025
Not yet recruiting
Qingdao, China, 266071
Not yet recruiting
Shanghai, China, 200003
Terminated
Shanghai, China, 200080
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Shanghai, China, 200032
Not yet recruiting
Shanghai, China, 200040
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
Terminated
Lyon, France, 69003
Recruiting
Lyon, France, 69003
Recruiting
Nice, France, 06002
Recruiting
Nimes, France, 30029
Recruiting
Paris, France, 75674
Recruiting
Paris, France, 75651
Recruiting
Paris, France, 75014
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
Not yet recruiting
Haidari, Attica, Greece, 12462
Not yet recruiting
Alexandroupolis, Greece, 68100
Not yet recruiting
Heraklion, Greece, 711 10
Not yet recruiting
Larissa, Greece, 41221
Not yet recruiting
Mezourlo / Larissa, Greece
Hungary
Recruiting
Budapest, Hungary, H-1125
Terminated
Budapest, Hungary, H-1204
Not yet recruiting
Budapest, Hungary, 1134
Recruiting
Budapest, Hungary, 1121
Terminated
Budapest, Hungary, 1115
Terminated
Budapest, Hungary, 1145
Recruiting
Kistarcsa, Hungary, 2143
Terminated
Miskolc, Hungary, 3501
Terminated
Szeged, Hungary, 6720
Not yet recruiting
Szekesfehervar, Hungary, 8000
Recruiting
Vac, Hungary, 2600
Terminated
Vac, Hungary, 2600
Israel
Not yet recruiting
Afula, Israel, 1834111
Not yet recruiting
Haifa, Israel, 3525408
Not yet recruiting
Holon, Israel, 58100
Recruiting
Petach Tikva, Israel, 4941492
Recruiting
Tel Aviv, Israel, 64239
Not yet recruiting
Tel Hashomer, Israel, 5262000
Italy
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Bergamo, Italy, 24127
Not yet recruiting
Milano, Italy, 20162
Not yet recruiting
Novara, Italy, 28100
Not yet recruiting
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
Not yet recruiting
Seto, Aichi, Japan, 489-8642
Not yet recruiting
Maebashi, Gunma, Japan, 371-8511
Not yet recruiting
Himeji, Hyogo, Japan, 670-8520
Not yet recruiting
Nakagun, Ibaraki, Japan, 319-1113
Not yet recruiting
Morioka, Iwate, Japan, 020-8505
Terminated
Sagamihara, Kanagawa, Japan, 252-0375
Not yet recruiting
Matsusaka, Mie, Japan, 515-8544
Terminated
Matsumoto, Nagano, Japan, 399-0021
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Omura, Nagasaki, Japan, 856-8562
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Sasebo, Nagasaki, Japan, 857-8511
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Shimajiri-gun, Okinawa, Japan, 901-1105
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Izumisano, Osaka, Japan, 598-8577
Terminated
Sakai, Osaka, Japan, 591-8555
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Bunkyo-ku, Tokyo, Japan, 113-8519
Terminated
Bunkyo-ku, Tokyo, Japan, 113-8655
Not yet recruiting
Itabashi-ku, Tokyo, Japan, 173-8606
Terminated
Ota-ku, Tokyo, Japan, 143-8541
Terminated
Hofu, Yamaguchi, Japan, 747-8511
Recruiting
Kumamoto, Japan, 860-0008
Not yet recruiting
Kumamoto, Japan, 860-8556
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Kyoto, Japan, 607-8062
Not yet recruiting
Nagasaki, Japan, 852-8501
Not yet recruiting
Niigata, Japan, 950-1197
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Niigata, Japan, 951-8520
Not yet recruiting
Okayama, Japan, 700-8505
Terminated
Osaka, Japan, 558-8558
Not yet recruiting
Osaka, Japan, 543-0035
Recruiting
Osaka, Japan, 540-0006
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, 31-826
Terminated
Krakow, Poland, 31-503
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, 123060
Terminated
Moscow, Russian Federation, 117049
Terminated
Novosibirsk, Russian Federation, 630008
Terminated
Novosibirsk, Russian Federation, 630051
Not yet recruiting
Smolensk, Russian Federation, 214018
Terminated
St. Petersburg, Russian Federation, 196247
Not yet recruiting
Yaroslavl, Russian Federation, 150003
Singapore
Not yet recruiting
Singapore, Singapore
Not yet recruiting
Singapore, Singapore, 529889
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
Not yet recruiting
Barcelona, Spain, 08035
Not yet recruiting
Barcelona, Spain, 08036
Terminated
Barcelona, Spain, 08035
Recruiting
Girona, Spain, 17007
Not yet recruiting
Madrid, Spain, 28040
Recruiting
Madrid, Spain, 28034
Recruiting
Valencia, Spain, 46026
Switzerland
Not yet recruiting
Bern, Switzerland, 3010
Not yet recruiting
Genève, Switzerland, 1211
Ukraine
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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
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 6, 2014
Health Authority: Belgium: Institutional Review Board
Germany: Ethics Commission
France: Ministry of Health
Italy: Ministry of Health
Spain: Ministry of Health
Poland: Ministry of Health
Switzerland: Swiss Agency for Theraputic Products
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, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amikacin
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014