ICU Patients With ECMO And-or RRT and With Gram Negative Infections Susceptible to BL-BLIsNCT07287813
Extracorporeal Therapy and Therapeutic Drug Monitoring
An observational study of ICU Patients With ECMO And-or RRT and With Gram Negative Infections Susceptible to BL-BLIs, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
The aim of this study is to comparatively evaluate serum concentrations of continuously applied antibiotics in ICU patients, with and without ECMO/RRT support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patients With ECMO And-or RRT and With Gram Negative Infections Susceptible to BL-BLIs
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 12 Dec 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: ICU patients with ECMO and/or RRT and with gram-negative infections susceptible to BL/BLIs
Who may be able to join
- adult patients (age 18y or older)
- admitted to ICU
- supported or not-supported with extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy (RRT)
- affected by gram-negative bacterial infections susceptible to the novel antibiotics.
Who cannot join
- Pediatric age (<18y)
- allergies to pharmaceutical and/or inactive drug ingredients (excipients)
- life expectancy less than 1 month
- body mass index (BMI) >45 kg/m2
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
Simona De Gregori, +39 0382503647, s.degregori@smatteo.pv.it
About this study
Official title: Pharmacokinetics/Pharmacodynamics and Therapeutic Drug Monitoring of Novel β-lactams and β-lactamase Inhibitors in Critically Ill Patients Undergoing Extracorporeal Therapy
The aim of this study is to comparatively evaluate serum concentrations of continuously applied antibiotics in ICU patients, with and without ECMO/RRT support.
Read the detailed description
Among all patients being treated with new generation antibiotics (beta.lactams and beta-lactamase inhibitors), we will take into consideration the results of those admitted to intensive care units.
Effective antimicrobial treatment is critical to reduce their mortality associated with bacterial sepsis. They often also require extracorporeal supports, such as renal replacement therapy (RRT) and extracorporeal membrane oxygenation (ECMO), for their survival. However, few studies, limited only to some drugs, report the importance of therapeutic drug monitoring for adequate dose adjustment in these particular conditions of extracoporeal support.
The risk of reaching sub therapeutic or toxic levels is quite high, due to possible very significant variations in the pharmacokinetics of the drugs because of their interaction with the various components of the ECMO and RRT devices, the characteristics of the drug itself and the pathophysiological changes of the patients on ECMO and/or RRT.
Primary aim is to evaluate whether the standard prescriptions of beta lactams/beta lactamase inhibitors (BL/BLIs) are adequate to achieve the optimal PK/PD target also for ECMO and RRT (or combined) patients admitted to intensive care unit.
Secondary aims include to evaluate:
- the occurrence of sub-therapeutic and/or toxic drugs levels
- the proportion of patients with insufficient drugs levels in different subgroups (i.e., absence of extracorporeal therapy vs. ECMO; absence of extracorporeal therapy vs. RRT, absence of extracorporeal therapy vs ECMO and RRT) - the proportion of patients with toxic or sub-therapeutic drugs levels in the same subgroups;
- the proportion, when possible, of drugs level before and during the extracorporeal therapy, for the same patient;
- the occurrence of drug resistance by pathogens and their mechanism
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary aim
evaluate whether the standard prescriptions of beta lactams/beta lactamase inhibitors (BL/BLIs) are adequate to achieve the optimal PK/PD target also for ECMO and RRT (or combined) patients admitted to intensive care unit.
Measured: up to 24 months
Secondary outcomes (5)
occurrence of sub-therapeutic and/or toxic drugs levels
Measured: up to 24 months
proportion of patients with insufficient drugs levels in different subgroups
Measured: up to 24 months
proportion of patients with toxic or sub-therapeutic drugs levels in the same subgroups
Measured: up to 24 months
proportion, when possible, of drugs level before and during the extracorporeal therapy, for the same patient
Measured: up to 24 months
occurrence of drug resistance by pathogens and their mechanism
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start12 Dec 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Patients With ECMO And-or RRT and With Gram Negative Infections Susceptible to BL-BLIsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona De Gregori, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287813
- Sponsor's protocol ID
- BL/BLIs in ICU - 2024
- Status last verified
- Aug 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics/Pharmacodynamics and Therapeutic Drug Monitoring of Novel β-lactams and β-lactamase Inhibitors in Critically Ill Patients Undergoing Extracorporeal Therapy
- ClinicalTrials.gov ID
- NCT07287813
- Acronym / sponsor ID
- BL/BLIs in ICU - 2024
- Conditions
- ICU Patients With ECMO And-or RRT and With Gram Negative Infections Susceptible to BL-BLIs
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 12 Dec 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Dec 2025 (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 aim of this study is to comparatively evaluate serum concentrations of continuously applied antibiotics in ICU patients, with and without ECMO/RRT support.
Detailed description
Among all patients being treated with new generation antibiotics (beta.lactams and beta-lactamase inhibitors), we will take into consideration the results of those admitted to intensive care units.
Effective antimicrobial treatment is critical to reduce their mortality associated with bacterial sepsis. They often also require extracorporeal supports, such as renal replacement therapy (RRT) and extracorporeal membrane oxygenation (ECMO), for their survival. However, few studies, limited only to some drugs, report the importance of therapeutic drug monitoring for adequate dose adjustment in these particular conditions of extracoporeal support.
The risk of reaching sub therapeutic or toxic levels is quite high, due to possible very significant variations in the pharmacokinetics of the drugs because of their interaction with the various components of the ECMO and RRT devices, the characteristics of the drug itself and the pathophysiological changes of the patients on ECMO and/or RRT.
Primary aim is to evaluate whether the standard prescriptions of beta lactams/beta lactamase inhibitors (BL/BLIs) are adequate to achieve the optimal PK/PD target also for ECMO and RRT (or combined) patients admitted to intensive care unit.
Secondary aims include to evaluate:
- the occurrence of sub-therapeutic and/or toxic drugs levels
- the proportion of patients with insufficient drugs levels in different subgroups (i.e., absence of extracorporeal therapy vs. ECMO; absence of extracorporeal therapy vs. RRT, absence of extracorporeal therapy vs ECMO and RRT) - the proportion of patients with toxic or sub-therapeutic drugs levels in the same subgroups;
- the proportion, when possible, of drugs level before and during the extracorporeal therapy, for the same patient;
- the occurrence of drug resistance by pathogens and their mechanism
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients with ECMO and/or RRT and with gram-negative infections susceptible to BL/BLIs
Key inclusion criteria (4 listed)
- adult patients (age 18y or older)
- admitted to ICU
- supported or not-supported with extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy (RRT)
- affected by gram-negative bacterial infections susceptible to the novel antibiotics.
Key exclusion criteria (5 listed)
- Pediatric age (<18y)
- allergies to pharmaceutical and/or inactive drug ingredients (excipients)
- life expectancy less than 1 month
- body mass index (BMI) >45 kg/m2
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary aim
Time frame: up to 24 months
evaluate whether the standard prescriptions of beta lactams/beta lactamase inhibitors (BL/BLIs) are adequate to achieve the optimal PK/PD target also for ECMO and RRT (or combined) patients admitted to intensive care unit.
5 secondary outcomes
occurrence of sub-therapeutic and/or toxic drugs levels
Time frame: up to 24 months
proportion of patients with insufficient drugs levels in different subgroups
Time frame: up to 24 months
proportion of patients with toxic or sub-therapeutic drugs levels in the same subgroups
Time frame: up to 24 months
proportion, when possible, of drugs level before and during the extracorporeal therapy, for the same patient
Time frame: up to 24 months
occurrence of drug resistance by pathogens and their mechanism
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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.
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 ICU Patients With ECMO And-or RRT and With Gram Negative Infections Susceptible to BL-BLIs, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Dec 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simona De Gregori (+39 0382503647, s.degregori@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary aim (time frame: up to 24 months). 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 17 Dec 2025.