Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-03 @ 2:02 AM
Study NCT ID:
NCT03339869
Status:
UNKNOWN
Last Update Posted:
2017-11-14
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Drug Monitoring of Anti-infectious Drugs in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'patient hospitalized in intensive care unit'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-10', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dosage of betalactamins concentrations', 'timeFrame': '14 days', 'description': 'Target concentrations are determined from the PK/PD target defined for betalactamins in the intensive care patient, ie a steady-state concentration 100% of the time at 4-5xMIC.'}], 'secondaryOutcomes': [{'measure': 'efficacy of the treatment with the clinical response at the end of treatment', 'timeFrame': '14 days', 'description': 'Evaluate the efficacy of the treatment with the clinical response at the end of treatment and/or J14 according to the criteria of "resolution / improvement / failure" according to De Waele et al. (Intensive Care Medicine 2014 Sep; 40 (9): 1340-51)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection, Bacterial']}, 'referencesModule': {'references': [{'pmid': '40192838', 'type': 'DERIVED', 'citation': 'Zalta A, Trebuchon A, Daquin G, Velly L, Leone M, Blin O, Lagarde S, Guilhaumou R. Neural correlates of beta-lactam exposure in intensive care unit patients: an observational, prospective cohort study. J Neurol. 2025 Apr 7;272(5):320. doi: 10.1007/s00415-025-13067-3.'}]}, 'descriptionModule': {'briefSummary': 'This research targets four anti-infectives commonly prescribed in intensive care: ceftazidime, cefepime, cefotaxime and meropenem, used for severe infections For patient hospitalized in intensive care unit , there is little or no pharmacokinetic data for these four molecules.', 'detailedDescription': 'Antibiotics, and especially beta-lactams, are among the most used drugs in the world. The good use of antibiotics and the prevention of selection of resistant strains has been a public health priority for many years. In this context, it is essential to obtain effective antibiotic concentrations at the site of infection. In order to obtain effective concentrations, ceftazidime, cefepime, cefotaxime, piperacillin and meropenem are administered in this population by continuous infusion at high dose. Although beta-lactams are mostly well tolerated, they can cause adverse effects such as severe neurological toxicities.\n\nThe critically ill patient has physiological alterations that can significantly alter the pharmacokinetics of drugs. Several studies have clearly shown that the pharmacokinetics of beta-lactams in the critically ill patient is different from those of other patients. Depending on the clinical context and the co-morbidities of the patient, sub-therapeutic or potentially toxic concentrations can be observed for the same dosage. The risk of ineffective treatment and the development of resistance remains, despite the high doses administered. In addition, this pharmacokinetic variability may be responsible for the observation of toxic concentrations and the occurrence of adverse effects in this population.\n\nFollowing these arguments, therapeutic drug monitoring (TDM) of beta-lactams accompanied by personalized dosage adjustment appears to be an essential tool to optimize the management of critically ill patients. Although strongly recommended, the TDM of beta-lactams in the critically ill patient accompanied by a dosage adjustment is not currently performed systematically in all patients.\n\nThe objective of this study is to evaluate the impact of the use of a systematic therapeutic drug monitoring of beta-lactams in the critically ill treated with cefotaxime, ceftazidime, cefepime, meropenem or piperacillin, in terms of efficacy and prevention of neurotoxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (age\\> 18 years)\n* Patient hospitalized in intensive care for a duration greater than 7 days, treated with cefotaxime, ceftazidime, cefepime, piperacillin or meropenem according to a standardized dosing regimen.\n\nExclusion Criteria:\n\n* Age \\<18\n* Pregnant woman\n* Patient allergic to beta-lactams\n* No written informed consent by the patient or his/her (legal) representative'}, 'identificationModule': {'nctId': 'NCT03339869', 'acronym': 'STP-ATB-REA', 'briefTitle': 'Therapeutic Drug Monitoring of Anti-infectious Drugs in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Evaluation of the Use of Therapeutic Drug Monitoring in the Management of Infections in Intensive Care Unit Patients.', 'orgStudyIdInfo': {'id': '2017-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'blood sample group', 'description': 'Adult patient hospitalized in intensive care unit and treated for infection.', 'interventionNames': ['Other: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'description': "The blood samples will be taken from the patient's bed and then sent to the clinical pharmacology laboratory of Prof. Blin (DRC, Bat F, Timone Hospital).", 'armGroupLabels': ['blood sample group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Romain GUILHAUMOU', 'role': 'CONTACT', 'email': 'Romain.GUILHAUMOU@ap-hm.fr', 'phone': '491.38.96.56/75.65', 'phoneExt': '+33'}, {'name': 'Lionel VELLY', 'role': 'CONTACT', 'email': 'lionel.velly@ap-hm.fr', 'phone': '4 13 42 94 61', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Urielle DESALBRES', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}