In Vitro Activity of Ceftolozane/Tazobactam and Imipenem/Relebactam in Clinical Isolates of Pseudomonas Aeruginosa and Enterobacterales Collected From Hematology and Oncology Patients
ACTHEON
1 other identifier
observational
1,005
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 3, 2019
CompletedFirst Posted
Study publicly available on registry
December 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedDecember 12, 2019
December 1, 2019
7 months
December 3, 2019
December 10, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
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
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
Interventions
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
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
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
You may qualify if:
- P. aeruginosa isolates
- Enterobacterales isolates
You may not qualify if:
- Non P. aeruginosa isolates
- Non Enterobacterales isolates
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emilio Bouzalead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
HG Gregorio Marañón
Madrid, 28007, Spain
MeSH Terms
Conditions
Interventions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Phd, MD Senior Assesor
Study Record Dates
First Submitted
December 3, 2019
First Posted
December 12, 2019
Study Start
November 1, 2019
Primary Completion
May 31, 2020
Study Completion
September 30, 2020
Last Updated
December 12, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share
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).