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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of the ACTHEON Study is to evaluate the in vitro activity of ceftolozane-tazobactam, imipenem-relebactam and comparator agents (amoxicillin- clavulanate, piperacillin-tazobactam, ceftazidime, cefotaxime, cefepime, imipenem, meropenem, levofloxacin and amikacin; see list more details on page 7) against clinical isolates of P. aeruginosa and Enterobacterales prospectively collected from hematology and oncology patients with complicated intra-abdominal infections (cIAIs), complicated urinary infections (cUTIs), lower respiratory tract infections (LRTIs), and blood stream infections (BSIs) from 15 participating centers in Spain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftolozane/tazobactam | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Summary MIC and its distributions as susceptible, intermediate and resistant | Summary of MIC data, distribution presented as the cumulative MIC frequency, MIC50, MIC90, and MIC range for each antimicrobial and species. | 31 october 2020 |
| Summary of percentages of isolates | Summary of percentages of isolates interpreted as susceptible, intermediate and resistant isolates according to CLSI and EUCAST guidelines, when available, for each species and for the total study isolates. | 31 october 2020 |
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Inclusion Criteria:
Exclusion Criteria:
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Participating laboratories will prospectively collect the first 1,005 clinical isolates (510 P. aeruginosa isolates and 495 Enterobacterales isolates) starting in a preestablished date from patients with cIAIs, cUTIs, LRTIs, or BSIs
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilia Cercenado | Contact | +34-915868459 | emilia.cercenado@salud.madrid.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HG Gregorio Marañón | Recruiting | Madrid | 28007 | Spain |
Fiveteen laboratories (Participating laboratories) will participate under the direction of Dr. E. Cercenado, Department of Microbiology and Infectious Diseases, Gregorio Marañón University Hospital, Madrid, Spain (Central laboratory), on behalf of the GEIRAS-SEIMC (Group for the Study of Healthcare-Related Infections of the Spanish Society for Infectious Diseases and Clinical Microbiology).
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| imipenem- relebactam | Drug | 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 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000594038 | ceftolozane, tazobactam drug combination |
| C000633884 | imipenem, cilastatin and relebactam |
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