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

• Sponsor: Emilio Bouza (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04196608
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 1,005
• Location: 1
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 91.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ceftolozane/Tazobactam; Imipenem/Relebactam; Hematology and Oncology	Drug: Ceftolozane/tazobactam; Drug: imipenem- relebactam

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1005 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: In Vitro Activity of Ceftolozane/Tazobactam and Imipenem/Relebactam in Clinical Isolates of Pseudomonas Aeruginosa and Enterobacterales Collected From Hematology and Oncology Patients
• Actual Study Start Date: Nov 1, 2019
• Anticipated Primary Completion Date: May 31, 2020
• Anticipated Study Completion Date: Sep 30, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Summary MIC and its distributions as susceptible, intermediate and resistant [31 october 2020]

   Summary of MIC data, distribution presented as the cumulative MIC frequency, MIC50, MIC90, and MIC range for each antimicrobial and species.

2. Summary of percentages of isolates [31 october 2020]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. aeruginosa isolates

• Enterobacterales isolates

Exclusion Criteria:

• Non P. aeruginosa isolates

• Non Enterobacterales isolates

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HG Gregorio Marañón	Madrid		Spain	28007

Sponsors and Collaborators

• Emilio Bouza
• Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emilio Bouza, Phd, MD Senior Assesor, Hospital General Universitario Gregorio Marañon
• ClinicalTrials.gov Identifier: NCT04196608
• Other Study ID Numbers: MICRO.HGUGM.2019-008
• First Posted: Dec 12, 2019
• Last Update Posted: Dec 12, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Tazobactam; Imipenem; Ceftolozane; Ceftolozane, tazobactam drug combination; Relebactam

Study Results

No Results Posted as of Dec 12, 2019