In Vitro Activity of Ceftolozane/Tazobactam and Imipenem/Relebactam in Clinical Isolates of Pseudomonas Aeruginosa and Enterobacterales Collected From Hematology and Oncology Patients (ACTHEON)

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

Study Overview

• Status: Unknown
• Conditions: Ceftolozane/Tazobactam; Imipenem/Relebactam; Hematology and Oncology
• Intervention / Treatment: Drug: Ceftolozane/tazobactam; Drug: imipenem- relebactam

• Study Type: Observational
• Enrollment (Anticipated): 1005

Contacts and Locations

• Study Contact: Name: Emilia Cercenado; Phone Number: +34-915868459; Email: emilia.cercenado@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Recruiting
    • HG Gregorio Marañón
    • Contact: Emilia Cercenado; Phone Number: +34-915868459; Email: emilia.cercenado@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• P. aeruginosa isolates
• Enterobacterales isolates

Exclusion Criteria:

• Non P. aeruginosa isolates
• Non Enterobacterales isolates

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: 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; Drug: 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	Drug: 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; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Emilio Bouza
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Imipenem; Relebactam; Tazobactam; Ceftolozane; Ceftolozane, tazobactam drug combination
• Other Study ID Numbers: MICRO.HGUGM.2019-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No