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

Ceftolozane/Tazobactam Clinical Trial

— ACTHEON  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04196608
• Other study ID #: MICRO.HGUGM.2019-008
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2019
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Emilia Cercenado
• Phone: +34-915868459
• Email: emilia.cercenado[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1005
• Est. completion date: September 30, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• P. aeruginosa isolates

• Enterobacterales isolates

Exclusion Criteria:

• Non P. aeruginosa isolates

• Non Enterobacterales isolates

Related Conditions & MeSH terms

• Ceftolozane/Tazobactam
• Hematology and Oncology
• Imipenem/Relebactam
• Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	HG Gregorio Marañón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Emilio Bouza	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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