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

• Conditions: Ceftolozane/Tazobactam; Imipenem/Relebactam; Hematology and Oncology
• Interventions: Drug: Ceftolozane/tazobactam; Drug: imipenem- relebactam

• Registration Number: NCT04196608
• Lead Sponsor: Emilio Bouza

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Study First Posted: 2019-12-12
• Last Update Posted: 2019-12-12
• Primary Completion: 2020-05-31
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1005

Inclusion Criteria

• P. aeruginosa isolates
• Enterobacterales isolates

Exclusion Criteria

• Non P. aeruginosa isolates
• Non Enterobacterales isolates

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
P. aeruginosa isolates	imipenem- relebactam	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	Ceftolozane/tazobactam	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	imipenem- relebactam	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
P. aeruginosa isolates	Ceftolozane/tazobactam	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

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

HG Gregorio Marañón; 🇪🇸 Madrid, Spain