Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-23 @ 4:18 PM
Study NCT ID:
NCT02694458
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2016-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Dosage Adjustment Strategies of Vancomycin in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2016-02-24', 'studyFirstSubmitQcDate': '2016-02-24', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with vancomycin AUC/MIC ≥ 400 and serum trough concentration ≤ 20 mg/L', 'timeFrame': '24th hour of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vancomycin', 'Children', 'Infection', 'Antibiotic', 'Methicillin-resistant Staphylococcus aureus (MRSA)', 'Population-based pharmacokinetic modeling', 'Pharmacokinetics', 'Pharmacodynamics', 'Bayesian approach', 'Therapeutic drug monitoring'], 'conditions': ['Methicillin-resistant Staphylococcal Infections']}, 'referencesModule': {'references': [{'pmid': '3632448', 'type': 'BACKGROUND', 'citation': 'Jordan DR, Anderson RL. A simple procedure for adjusting eyelid position after aponeurotic ptosis surgery. Arch Ophthalmol. 1987 Sep;105(9):1288-91. doi: 10.1001/archopht.1987.01060090146046.'}, {'pmid': '4275137', 'type': 'BACKGROUND', 'citation': 'Hikida RS, Lombardo JA. Regeneration of pigeon fast and slow muscle fiber types after partial excision and mincing. J Cell Biol. 1974 May;61(2):414-26. doi: 10.1083/jcb.61.2.414.'}, {'pmid': '21208910', 'type': 'BACKGROUND', 'citation': 'Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF; Infectious Diseases Society of America. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011 Feb 1;52(3):e18-55. doi: 10.1093/cid/ciq146. Epub 2011 Jan 4.'}, {'pmid': '31591117', 'type': 'RESULT', 'citation': 'Berthaud R, Benaboud S, Hirt D, Genuini M, Oualha M, Castelle M, Briand C, Artru S, Norsa L, Boyer O, Foissac F, Bouazza N, Treluyer JM. Early Bayesian Dose Adjustment of Vancomycin Continuous Infusion in Children: a Randomized Controlled Trial. Antimicrob Agents Chemother. 2019 Sep 9;63(12):e01102-19. doi: 10.1128/AAC.01102-19. Epub 2019 Oct 7.'}]}, 'descriptionModule': {'briefSummary': "Vancomycin is the standard first-line treatment for MRSA infections and a first-line empiric therapy. The relationship between exposure to vancomycin and efficacy is admitted but because of an important intersubject variability, therapeutic exposure isn't usually achieved.\n\nThe primary aim of this randomized controlled trial is to evaluate a new early dosage adjustment strategy of vancomycin in children, comparing it to the usual treatment strategy.\n\nUsing a bayesian approach, the purpose is to achieve earlier a therapeutic and non-toxic exposure to vancomycin.\n\nThe primary hypothesis is that an early dosage adjustment strategy using a bayesian approach will allow patients to achieve the vancomycin pharmacological target faster than with the usual treatment strategy.", 'detailedDescription': 'Introduction/ Clinical significance :\n\nStaphylococcus aureus is a common cause of serious infections. Methicillin-resistant Staphylococcus aureus (MRSA) are one of the most common causes of nosocomial antibiotic resistant bacterial infections in the world. According to the last data from the European Antimicrobial Resistance Network, in 2014, 17,4 % of invasive staphylococcal infections are due to MRSA in France, with proportions of up to 56 % in some regions in the European Economic Area (EEA). In the United-States of America, MRSA reach 50 % of Staphylococcus isolates in some studies. Vancomycin is the standard first-line treatment for MRSA infections and a first-line empiric therapy.\n\nTo optimize good clinical outcomes for invasive MRSA infections using pharmacokinetics-pharmacodynamics of vancomycin, studies support targeting area under the curve (AUC) of the serum concentration versus time over 24 hours to minimum inhibitory concentration (MIC) ratio ≥ 400, which frequently correlates to a trough concentration of 15 - 20 mg/L when the MIC is 1 mg/L. Because of few consensus regarding the dosage to use and high intersubject variability, this pharmacological target is difficult to reach in children, which may lead to a delayed infection control and an increase of vancomycin toxicity-related side effects.\n\nAims :\n\nThe primary aim is to evaluate an early dosage adjustment strategy of vancomycin in children, comparing it to the usual treatment strategy.\n\nUsing a bayesian approach, the main purpose is to achieve earlier a therapeutic and non-toxic exposure to vancomycin.\n\nThe secondary aims are to compare with the usual treatment strategy 1) the proportion of subjects with vancomycin serum concentration within the concentration targets at the 24th hour of treatment, and 2) the clinical (in terms of fever), biological (in terms of CRP) and bacteriological (in terms of blood culture) efficacy of this early dosage adjustment strategy of vancomycin.\n\nHypothesis :\n\nThis study hypothesizes that early dosage adjustment strategy of vancomycin using a bayesian approach will be superior to usual treatment strategy in achieving the pharmacological target of vancomycin at the 24th hour of treatment in children.\n\nMethodology :\n\nAs part of routine care, a prospective open-label randomized controlled trial will be conducted in a major paediatric hospital in Paris, France. Subjects will be divided into two arms. Each arm will contain 50 subjects.\n\nFor subjects of the Modeling arm, drug concentration will be measured at the 3rd hour of treatment and dosage adjustment will be done at the 6th hour of treatment using a bayesian approach. Vancomycin serum concentration will be then measured at the 24th hour of treatment.\n\nSubjects of the control arm will receive the usual treatment strategy. Vancomycin serum concentration will be measured at the 24th hour of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 1 months to 16 years\n* Children for whom a vancomycin treatment is started in the hospital Necker-Enfants Malades in Paris, France\n* No objection of parents and of the child himself if he is able to express it.\n\nExclusion Criteria:\n\n* Patients undergoing hemodialysis\n* Patients undergoing peritoneal dialysis\n* Newborns less than 1 months old\n* Adolescents more than 16 years old and adults'}, 'identificationModule': {'nctId': 'NCT02694458', 'acronym': 'OPTIBAYE', 'briefTitle': 'Comparison of Two Dosage Adjustment Strategies of Vancomycin in Children', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Comparison of Two Dosage Adjustment Strategies of Vancomycin in Children', 'orgStudyIdInfo': {'id': '2015-A01545-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modeling arm', 'description': 'Early vancomycin monitoring and bayesian dosage adjustment', 'interventionNames': ['Other: Early vancomycin monitoring and bayesian dosage adjustment']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control arm', 'description': 'Usual vancomycin dose and monitoring strategy', 'interventionNames': ['Other: usual vancomycin dose and monitoring strategy']}], 'interventions': [{'name': 'Early vancomycin monitoring and bayesian dosage adjustment', 'type': 'OTHER', 'description': 'Measure of vancomycin serum concentration at the 3rd hour of treatment and adjustment of vancomycin dosage at the 6th hour of treatment using a bayesian approach. Then measure of vancomycin serum concentration at the 24th hour of treatment.', 'armGroupLabels': ['Modeling arm']}, {'name': 'usual vancomycin dose and monitoring strategy', 'type': 'OTHER', 'description': 'Vancomycin serum concentration will be measured at the 24th hour of treatment.', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-Marc TRELUYER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Necker-Enfants Malades'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}