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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04196608

Acronym

ACTHEON

Enrollment

1005

Registered

2019-12-12

Start date

2019-11-01

Completion date

2020-09-30

Last updated

2019-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ceftolozane/Tazobactam, Imipenem/Relebactam, Hematology and Oncology

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

Interventions

DRUGCeftolozane/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

DRUGimipenem- relebactam

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* P. aeruginosa isolates * Enterobacterales isolates

Exclusion criteria

* Non P. aeruginosa isolates * Non Enterobacterales isolates

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Countries

Spain

Contacts

Primary ContactEmilia Cercenado

emilia.cercenado@salud.madrid.org+34-915868459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026