Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2025-12-12
2027-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* allergies to pharmaceutical and/or inactive drug ingredients (excipients)
* life expectancy less than 1 month
* body mass index (BMI) \>45 kg/m2
* pregnancy
18 Years
ALL
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Responsible Party
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Simona De Gregori
PhD in Chemical Sciences
Locations
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Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
Countries
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Central Contacts
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Facility Contacts
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Simona De Gregori
Role: primary
Other Identifiers
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BL/BLIs in ICU - 2024
Identifier Type: -
Identifier Source: org_study_id