Ceftolozane/TazobactamACTHEONNCT04196608
In Vitro Activity of Ceftolozane/Tazobactam and Imipenem/Relebactam in Clinical Isolates of Pseudomonas Aeruginosa and Enterobacterales Collected From Hematology and Oncology Patients
An observational study of Ceftolozane/Tazobactam and Imipenem/Relebactam, run by Emilio Bouza at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ceftolozane/Tazobactam, Imipenem/Relebactam, Hematology and Oncology
- What is being tested?
- Ceftolozane/tazobactam and imipenem- relebactam
- How many people
- 1,005 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- P. aeruginosa isolates
- Enterobacterales isolates
Who cannot join
- Non P. aeruginosa isolates
- Non Enterobacterales isolates
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
HG Gregorio Marañón
Madrid, 28007
Emilia Cercenado, +34-915868459, emilia.cercenado@salud.madrid.org
About this study
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
- Being tested
- Ceftolozane/tazobactam, imipenem- relebactam
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftolozane/tazobactamDrug
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- relebactamDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ceftolozane/tazobactam; Drug: imipenem- relebactam | |
| 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 Receives: Drug: Ceftolozane/tazobactam; Drug: imipenem- relebactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 31 october 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Nov 2019
- Primary completion31 May 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ceftolozane/TazobactamStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,005 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emilio Bouza
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Emilio Bouza, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196608
- Sponsor's protocol ID
- MICRO.HGUGM.2019-008
- Acronym
- ACTHEON
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04196608
- Acronym / sponsor ID
- ACTHEON / MICRO.HGUGM.2019-008
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,005 participants (estimated)
- Lead sponsor
- Emilio BouzaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P. aeruginosa isolates | – | Drug: Ceftolozane/tazobactam, Drug: imipenem- relebactamAll 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 | – | Drug: Ceftolozane/tazobactam, Drug: imipenem- relebactamAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- P. aeruginosa isolates
- Enterobacterales isolates
Key exclusion criteria (2 listed)
- Non P. aeruginosa isolates
- Non Enterobacterales isolates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftolozane/tazobactamMinimum 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 | Enterobacterales isolates, P. aeruginosa isolates |
| imipenem- relebactamMinimum 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 | Enterobacterales isolates, P. aeruginosa isolates |
Primary outcome
Summary MIC and its distributions as susceptible, intermediate and resistant
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Individual participant dataSharing planned: No. 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).
Related trials for Ceftolozane/Tazobactam
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ceftolozane/Tazobactam and Imipenem/Relebactam, run by Emilio Bouza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilia Cercenado (+34-915868459, emilia.cercenado@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary MIC and its distributions as susceptible, intermediate and resistant (time frame: 31 october 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.