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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00805168
First Posted: December 9, 2008
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Nektar Therapeutics
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Bayer
  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).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 patients deemed to be clinical successes in the BAY41-6551 treatment group divided by the proportion of cured patients in the placebo treatment group [ Time Frame: Late follow-up (LFU) visit (day 28-32) ]

Secondary Outcome Measures:
  • Pneumonia-related mortality through the LFU visit [ Time Frame: 28-32 days after start of treatment with study medication ]
  • Early Clinical Response which is based on CPIS scores, the presence of empyema or lung abscess, and all-cause mortality [ Time Frame: Assessed through day 10 ]
    Early Clinical Response success occurs if there is no rise of 2 points or more on Day 3, and a drop of 1 or more points on Day 5 and a drop 2 or more points on Day 10, and the absence of lung abscess or empyema by Day 10, and alive on Day 10.

  • Number of days on mechanical ventilation through the LFU visit [ Time Frame: 28-32 days after start of treatment with study medication ]
  • Number of days in the ICU through the LFU visit [ Time Frame: 28-32 days after start of treatment with study medication ]
  • Number of patients who received at least one dose of study drug and reported an adverse event [ Time Frame: 35-39 days after start of treatment with study medication ]
  • Number of patients who received at least one dose of study drug and reported a serious adverse event [ Time Frame: 28-32 days after start of treatment with study medication ]
  • Progression and incidence rates of organ failure [ Time Frame: 28-32 days after start of treatment with study medication ]
  • All-cause mortality rate [ Time Frame: 28-32 days after start of treatment with study medication ]
  • Identification of laboratory data outside normal ranges [ Time Frame: 28-32 days after start of treatment with study medication ]
  • Per pathogen microbiological response rates at the Test-of-Cure (TOC) visit [ Time Frame: 17-19 days after start of treatment with study medication ]
  • Per patient microbiological response rates at the TOC visit [ Time Frame: 17-19 days after start of treatment with study medication ]
  • Microbiological recurrence rates at the TOC and LFU visits [ Time Frame: 17-19 days and 28-32 days respectively after start of treatment with study medication ]
  • Emergence of new respiratory pathogens during the aerosol treatment period [ Time Frame: Days 1-10 ]
  • Emergence of resistance among baseline pathogens in those patients with persistent infection or colonization [ Time Frame: 28-32 days after start of treatment with study medication ]

Enrollment: 461
Actual Study Start Date: May 28, 2013
Study Completion Date: April 7, 2017
Primary Completion Date: April 7, 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805168


  Hide Study Locations
Locations
Belgium
Antwerpen, Belgium, 2060
Bruxelles - Brussel, Belgium, 1070
Bruxelles - Brussel, Belgium, 1090
Bruxelles - Brussel, Belgium, 1200
Gent, Belgium, 9000
Yvoir, Belgium, 5530
China, Fujian
Fuzhou, Fujian, China, 350025
Fuzhou, Fujian, China
China, Guangdong
Guangzhou, Guangdong, China, 510120
Guangzhou, Guangdong, China, 510515
Guangzhou, Guangdong, China
Shenzhen, Guangdong, China
China, Guangxi
Nanning, Guangxi, China, 530021
China, Hainan
Haikou, Hainan, China, 570311
Haikou, Hainan, China
China, Hubei
Wuhan, Hubei, China, 430030
Wuhan, Hubei, China, 430060
China, Hunan
Changsha, Hunan, China, 410008
Changsha, Hunan, China, 410011
Changsha, Hunan, China, 410013
China, Inner Mongolia
Baotou, Inner Mongolia, China, 014010
China, Jiangsu
Nanjing, Jiangsu, China, 210029
Suzhou, Jiangsu, China, 215006
China, Jilin
Changchun, Jilin, China, 130021
China, Liaoning
Shenyang, Liaoning, China, 110001
Shenyang, Liaoning, China, 110004
China, Ningxia
Yinchuan, Ningxia, China, 750004
China, Shaanxi
Xi'an, Shaanxi, China, 710032
Xi'an, Shaanxi, China, 710061
China, Shandong
Jinan, Shandong, China
Qingdao, Shandong, China, 266000
Qingdao, Shandong, China, 266071
China, Sichuan
Chengdu, Sichuan, China, 610041
Chengdu, Sichuan, China
China, Xinjiang
Urumchi, Xinjiang, China, 830054
China, Zhejiang
Hangzhou, Zhejiang, China, 310016
China
Beiing, China, 100048
Beijing, China, 100020
Beijing, China, 100029
Beijing, China, 100038
Beijing, China, 100044
Beijing, China, 100088
Beijing, China, 100191
Beijing, China, 100853
Beijing, China
Changsha, China
Chongqing, China, 400010
Chongqing, China, 400016
Chongqing, China, 400038
Chongqing, China, 400042
Shanghai, China, 200003
Shanghai, China, 200032
Shanghai, China, 200040
Shanghai, China, 200080
Shanghai, China, 200092
Tianjin, China, 300052
France
Angers Cedex, France, 49100
Argenteuil Cedex, France, 95107
Colombes, France, 92701
Creteil, France, 94010
Lille Cedex, France, 59037
Limoges, France, 87042
Lyon, France, 69003
Nancy, France, 54037
Nice Cedex 3, France, 06202
Nimes, France, 30029
Paris Cedex 04, France, 75181
Paris, France, 75014
Paris, France, 75651
Paris, France, 75674
Paris, France, 75877
Poitiers, France, 86021
Saint Michel, France, 16470
Toulouse, France, 31059
Vesoul, France, 70014
Villefranche Sur Saône Cedex, France, 69655
Germany
Mannheim, Baden-Württemberg, Germany, 68167
Tübingen, Baden-Württemberg, Germany, 72076
München, Bayern, Germany, 81545
Regensburg, Bayern, Germany, 93053
Frankfurt, Hessen, Germany, 60590
Rostock, Mecklenburg-Vorpommern, Germany, 181057
Halle, Sachsen-Anhalt, Germany, 06112
Leipzig, Sachsen, Germany, 04289
Berlin, Germany, 10117
Berlin, Germany, 13353
Greece
Alexandroupolis, Greece, 68100
Haidari, Greece, 12462
Heraklion, Greece, 711 10
Larissa, Greece, 41221
Mezourlo / Larissa, Greece
Hungary
Budapest, Hungary, 1115
Budapest, Hungary, 1121
Budapest, Hungary, 1125
Budapest, Hungary, 1134
Budapest, Hungary, 1145
Budapest, Hungary, H-1204
Kistarcsa, Hungary, 2143
Miskolc, Hungary, 3501
Szeged, Hungary, 6720
Szekesfehervar, Hungary, 8000
Vac, Hungary, 2600
Israel
Afula, Israel, 1834111
Haifa, Israel, 3109601
Holon, Israel, 5810001
Petah Tikva, Israel, 4941492
Ramat Gan, Israel, 5262000
Tel Aviv, Israel, 64239
Italy
Bergamo, Lombardia, Italy, 24127
Milano, Lombardia, Italy, 20162
Pavia, Lombardia, Italy, 27100
Novara, Piemonte, Italy, 28100
Padova, Veneto, Italy, 35128
Japan
Nagakute, Aichi, Japan, 480-1195
Nagoya, Aichi, Japan, 454-8502
Nagoya, Aichi, Japan, 460-0001
Seto, Aichi, Japan, 489-8642
Onga, Fukuoka, Japan, 807-0051
Maebashi, Gunma, Japan, 371-8511
Ota, Gunma, Japan, 373-8585
Himeji, Hyogo, Japan, 670-8520
Nakagun, Ibaraki, Japan, 319-1113
Morioka, Iwate, Japan, 020-8505
Sagamihara, Kanagawa, Japan, 252-0375
Yokohama, Kanagawa, Japan, 230-8765
Matsusaka, Mie, Japan, 515-8544
Matsumoto, Nagano, Japan, 399-0021
Omura, Nagasaki, Japan, 856-8562
Sasebo, Nagasaki, Japan, 857-8511
Shimajiri-gun, Okinawa, Japan, 901-1193
Hirakata, Osaka, Japan, 573-1191
Izumisano, Osaka, Japan, 598-8577
Sakai, Osaka, Japan, 591-8555
Bunkyo-ku, Tokyo, Japan, 113-8519
Bunkyo-ku, Tokyo, Japan, 113-8655
Itabashi-ku, Tokyo, Japan, 173-8606
Ota-ku, Tokyo, Japan, 143-8541
Hofu, Yamaguchi, Japan, 747-8511
Fukuoka, Japan, 811-0213
Kumamoto, Japan, 860-0008
Kumamoto, Japan, 860-8556
Kyoto, Japan, 607-8062
Nagasaki, Japan, 852-8501
Niigata, Japan, 950-1197
Niigata, Japan, 951-8520
Okayama, Japan, 700-8505
Osaka, Japan, 540-0006
Osaka, Japan, 543-0035
Osaka, Japan, 558-8558
Netherlands
Amsterdam, Netherlands, 1081 HV
Amsterdam, Netherlands, 1105 AZ
Enschede, Netherlands, 7511 JX
Nijmegen, Netherlands, 6525 GA
Rotterdam, Netherlands, 3083 AN
Utrecht, Netherlands, 3584 CX
Poland
Bydgoszcz, Poland, 85-094
Krakow, Poland, 31-503
Krakow, Poland, 31-826
Lodz, Poland, 90-549
Poznan, Poland, 60-355
Poznan, Poland, 60-479
Szczecin, Poland, 70-111
Szczecin, Poland, 71-252
Warszawa, Poland, 02-005
Portugal
Braga, Portugal, 4710-243
Porto, Portugal, 4099
Porto, Portugal, 4200-072
Porto, Portugal, 4200-319
Russian Federation
Moscow, Russian Federation, 117049
Moscow, Russian Federation, 117997
Moscow, Russian Federation, 123060
Novosibirsk, Russian Federation, 630008
Novosibirsk, Russian Federation, 630051
Smolensk, Russian Federation, 214018
St. Petersburg, Russian Federation, 196247
Yaroslavl, Russian Federation, 150003
Yekaterinburg, Russian Federation, 620102
Yekaterinburg, Russian Federation, 620109
Spain
Badalona, Barcelona, Spain, 08916
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Terrassa, Barcelona, Spain, 08221
Barcelona, Catalunya, Spain, 08003
Getafe, Madrid, Spain, 28905
Alicante, Spain, 03010
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Girona, Spain, 17007
Madrid, Spain, 28034
Madrid, Spain, 28040
Valencia, Spain, 46026
Ukraine
Kharkiv, Ukraine, 61018
Kiev, Ukraine, 03110
Kyiv, Ukraine, 01133
Lugansk, Ukraine, 91045
Poltava, Ukraine, 36011
Vinnitsa, Ukraine, 21000
Sponsors and Collaborators
Bayer
Nektar Therapeutics
Novartis Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00805168     History of Changes
Other Study ID Numbers: 13085
2008-000906-35 ( EudraCT Number )
First Submitted: December 8, 2008
First Posted: December 9, 2008
Last Update Posted: July 7, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Pharmaceutical Solutions
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents