Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT05354635
Status:
UNKNOWN
Last Update Posted:
2022-04-29
First Post:
2022-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2022-04-26', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence of at least one "underdosing" event of one of the Antibiotics used in a patient included during his or her hospitalization in pediatrics intensive care unit (PICU)', 'timeFrame': '2 months', 'description': 'Underdosing is defined as a measurement of plasma concentration below the optimal therapeutic concentration (OTC)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intensive Care Units, Pediatric']}, 'descriptionModule': {'briefSummary': 'Currently, recommendations for antibiotic testing (ATS) in adult intensive care have been published. The 2018 SFAR and the Abdul- Aziz et al expert conference recommend routine testing for β-lactams, aminoglycosides, linezolid, and vancomycin and provide plasma concentration goals. No recommendations have been made for the pediatric intensive care unit (PICU) population. However, several articles report suboptimal plasma concentrations for the most frequently used antibiotics in PICU. The University Hospital of Reunion is the reference center for the western region of the Indian Ocean. This region presents a large mixed population due to the migratory flow, as well as a specific bacterial ecology. This suggests that the data already collected on antibiotic dosage in other European studies may not be fully extrapolated to Reunion Island.\n\nIt is in this context that we will study the plasma concentration of antibiotics for all children who received the most commonly used antibiotics (β-lactams, linezolid, vancomycin, and aminoglycosides) during their hospitalization in PICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The aim of the research is to evaluate the adequacy of antibiotic therapy in children admitted to the pediatric intensive care unit at the University Hospital of La Réunion. The study population is intended to be exhaustive and will include all subjects affiliated to the Social Security who meet the eligibility criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any child hospitalized in the pediatric intensive care unit of the CHU Nord de La Réunion,\n* Age is less than 18 years,\n* Having started a curative antibiotic therapy by β-lactam, linezolid, vancomycin or aminosides.\n* For whom a non-opposition has been collected orally from both or one of the child's legal guardians and from the child himself (if applicable),\n* Covered by Social Security.\n\nExclusion Criteria:\n\n-Patients on prophylactic antibiotic therapy"}, 'identificationModule': {'nctId': 'NCT05354635', 'acronym': 'STAR-P', 'briefTitle': 'Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care', 'orgStudyIdInfo': {'id': '2022/CHU/05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Antibiotics Dosing', 'type': 'OTHER', 'description': 'Dosing concerns the main antibiotics used in the unit: b-lactams, linezolid, vancomycin and aminosides'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97400', 'city': 'Saint-Denis', 'country': 'Reunion', 'contacts': [{'name': 'Lise PEIPOCH, MD', 'role': 'CONTACT', 'email': 'lise.peipoch@chu-reunion.fr', 'phone': '+262 262 90 63 90'}, {'name': 'Théa VENET, MD', 'role': 'CONTACT', 'email': 'thea.venet@chu-reunion.fr', 'phone': '+262 262 90 63 90'}], 'facility': 'CHU de la Réunion', 'geoPoint': {'lat': -20.88231, 'lon': 55.4504}}], 'centralContacts': [{'name': 'Lise PEIPOCH, MD', 'role': 'CONTACT', 'email': 'lise.peipoch@chu-reunion.fr', 'phone': '+262 262 90 63 90'}, {'name': 'Laetitia BERLY, PhD', 'role': 'CONTACT', 'email': 'laetitia.berly@chu-reunion.fr', 'phone': '+262 262 90 62 86'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}