In Vitro Activity of Ceftolozane/Tazobactam and Imipenem/Relebactam in Clinical Isolates of Pseudomonas Aeruginosa and Enterobacterales Collected From Hematology and Oncology Patients
NCT ID: NCT04196608
Last Updated: 2019-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1005 participants
OBSERVATIONAL
2019-11-01
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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P. aeruginosa isolates
All isolates will be sent to the Central Laboratory, where identification will be confirmed by MALDI-TOF and susceptibility testing against ceftolozane/tazobactam, imipenem- relebactam and comparative agents will be performed
Ceftolozane/tazobactam
Minimum inhibitory concentrations (MICs) will be determined by the standard broth microdilution method (standard ISO method 20776-1:2006) using dry-form Sensititre panels (Thermo Fisher Scientific, Denmark) and will be interpreted according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) and the Clinical and Laboratory Standards Institute (CLSI) criteria
imipenem- relebactam
Minimum inhibitory concentrations (MICs) will be determined by the standard broth microdilution method (standard ISO method 20776-1:2006) using dry-form Sensititre panels (Thermo Fisher Scientific, Denmark) and will be interpreted according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) and the Clinical and Laboratory Standards Institute (CLSI) criteria
Enterobacterales isolates
All isolates will be sent to the Central Laboratory, where identification will be confirmed by MALDI-TOF and susceptibility testing against ceftolozane/tazobactam, imipenem- relebactam and comparative agents will be performed
Ceftolozane/tazobactam
Minimum inhibitory concentrations (MICs) will be determined by the standard broth microdilution method (standard ISO method 20776-1:2006) using dry-form Sensititre panels (Thermo Fisher Scientific, Denmark) and will be interpreted according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) and the Clinical and Laboratory Standards Institute (CLSI) criteria
imipenem- relebactam
Minimum inhibitory concentrations (MICs) will be determined by the standard broth microdilution method (standard ISO method 20776-1:2006) using dry-form Sensititre panels (Thermo Fisher Scientific, Denmark) and will be interpreted according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) and the Clinical and Laboratory Standards Institute (CLSI) criteria
Interventions
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Ceftolozane/tazobactam
Minimum inhibitory concentrations (MICs) will be determined by the standard broth microdilution method (standard ISO method 20776-1:2006) using dry-form Sensititre panels (Thermo Fisher Scientific, Denmark) and will be interpreted according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) and the Clinical and Laboratory Standards Institute (CLSI) criteria
imipenem- relebactam
Minimum inhibitory concentrations (MICs) will be determined by the standard broth microdilution method (standard ISO method 20776-1:2006) using dry-form Sensititre panels (Thermo Fisher Scientific, Denmark) and will be interpreted according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) and the Clinical and Laboratory Standards Institute (CLSI) criteria
Eligibility Criteria
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Inclusion Criteria
* Enterobacterales isolates
Exclusion Criteria
* Non Enterobacterales isolates
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Emilio Bouza
OTHER
Responsible Party
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Emilio Bouza
Phd, MD Senior Assesor
Locations
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HG Gregorio Marañón
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Emilia Cercenado
Role: primary
Other Identifiers
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MICRO.HGUGM.2019-008
Identifier Type: -
Identifier Source: org_study_id