Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
NCT ID: NCT01799993
Last Updated: 2018-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
725 participants
INTERVENTIONAL
2013-04-13
2017-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Amikacin inhale (BAY41-6551)
Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.
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
Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.
Aerosolized Placebo
Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
Interventions
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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)
Aerosolized Placebo
Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
Eligibility Criteria
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Inclusion Criteria
* 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 a multi-drug resistant (MDR) organism in a pre-therapy respiratory specimen OR at least two risk factors for MDR organisms
Exclusion Criteria
* 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) \[Exception: Patients with a serum creatinine \> 2 mg/dL (177 µmol/L) and being treated with continuous renal replacement therapy (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or daily hemodialysis will receive the aerosol study drug treatment\]
* 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)
18 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Danbury, Connecticut, United States
Hartford, Connecticut, United States
Newark, Delaware, United States
Hollywood, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Springfield, Illinois, United States
Muncie, Indiana, United States
Iowa City, Iowa, United States
Hazard, Kentucky, United States
Kalamazoo, Michigan, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Butte, Montana, United States
Las Vegas, Nevada, United States
Brooklyn, New York, United States
Mineola, New York, United States
New York, New York, United States
New York, New York, United States
Asheville, North Carolina, United States
Greensboro, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Youngstown, Ohio, United States
Oklahoma City, Oklahoma, United States
Charleston, South Carolina, United States
Blacktown, New South Wales, Australia
Clayton, Victoria, Australia
Wollongong, , Australia
Belo Horizonte, Minas Gerais, Brazil
Campinas, São Paulo, Brazil
São José do Rio Preto, São Paulo, Brazil
Kingston, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, , Canada
Barranquilla, Atlántico, Colombia
Cali, Valle del Cauca Department, Colombia
Prague, , Czechia
Zlín, , Czechia
Guadalajara, Jalisco, Mexico
México, D.F., Mexico City, Mexico
Monterrey, Nuevo León, Mexico
Aguascalientes, , Mexico
San Luis Potosí City, , Mexico
Quezon City, , Philippines
Quezon City, , Philippines
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Kaohsiung City, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Chiang Mai, , Thailand
Khon Kaen, , Thailand
Ankara, , Turkey (Türkiye)
Trabzon, , Turkey (Türkiye)
Countries
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References
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Niederman MS, Alder J, Bassetti M, Boateng F, Cao B, Corkery K, Dhand R, Kaye KS, Lawatscheck R, McLeroth P, Nicolau DP, Wang C, Wood GC, Wunderink RG, Chastre J. Inhaled amikacin adjunctive to intravenous standard-of-care antibiotics in mechanically ventilated patients with Gram-negative pneumonia (INHALE): a double-blind, randomised, placebo-controlled, phase 3, superiority trial. Lancet Infect Dis. 2020 Mar;20(3):330-340. doi: 10.1016/S1473-3099(19)30574-2. Epub 2019 Dec 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2013-001048-73
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13084
Identifier Type: -
Identifier Source: org_study_id
NCT00805168
Identifier Type: -
Identifier Source: nct_alias
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