protocolSection identificationModule nctId: NCT06338345, orgStudyIdInfo id: 38RC23.0222, briefTitle: Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients, acronym: KAMELOT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-09-01, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: The use of antibiotic therapy is common in intensive care units and primarily involves beta-lactams. Its optimal implementation is made difficult by the pharmacokinetic changes inherent in critically ill patients.Despite the current recommendations from the French Society of Anesthesiology and Intensive Care (SFAR) and the French Society of Pharmacology and Therapeutics (SFPT), there are no recommendations on prescription modalities for patients under veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The use of antibiotic therapy is common in VA-ECMO patients and their pharmacokinetic variability factors are then exacerbated.We aim to conduct a prospective, multicenter, interventional study designed to identify predictive factors for failure to achieve therapeutic target circulating concentrations of beta-lactams in patients under VA-ECMO treated with one of the studied beta-lactams, conditionsModule conditions: Cardiogenic Shock, conditions: Post-cardiac Surgery, conditions: Cardiac Arrest, conditions: Extracorporeal Membrane Oxygenation Complication, conditions: Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Therapeutic drug monitoring of beta-lactam, outcomesModule primaryOutcomes measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem., primaryOutcomes measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem., primaryOutcomes measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem., primaryOutcomes measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem., primaryOutcomes measure: Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Clermont Ferrand - Hôpital Gabriel Montpied, city: Clermont-Ferrand, zip: 63003, country: France, geoPoint lat: 45.77966, lon: 3.08628, locations facility: CHU Dijon-Bourgogne, city: Dijon, zip: 21000, country: France, contacts name: Pierre-Alain BAHR, MD, role: CONTACT, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Aphp Pitie Salpetriere, city: Paris, zip: 75013, country: France, contacts name: PAULINE DUREAU, MD, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU ROUEN - Hôpital Charles-Nicolle, city: Rouen, zip: 76031, country: France, contacts name: Emmanuel BESNIER, MD, PhD, role: CONTACT, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Hôpital Rangueil - CHU Toulouse, city: Toulouse, zip: 31059, country: France, contacts name: Stéphanie RUIZ, MD, role: CONTACT, contacts name: Camille MANE, MD, role: CONTACT, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False