Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-06-17 @ 7:09 AM
Study NCT ID:
NCT05914467
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TDM-optimized Teicoplanin Dosing Versus Standard of Care
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': 'D017334', 'term': 'Teicoplanin'}], 'ancestors': [{'id': 'D000077427', 'term': 'Lipoglycopeptides'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized 1:1 between standard treatment and treatment guided by TDM with MIPD.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acute Kidney Injury (AKI)', 'timeFrame': '30 days after initiation of teicoplanin therapy', 'description': 'incidence of AKI during teicoplanin treatment. Occurrence of nephrotoxicity will be defined as a binary denominator complying to any of the following markers according to the Kidney Disease: Improving Global Outcomes (KDIGO) guideline for acute kidney injury.\n\n* Increase in serum creatinine of \\> 0.3 mg/dl within 48 hours\n* Increase in serum creatinine to \\> 1.5 times baseline, which is known or presumed to have occurred within the prior 7 day'}], 'primaryOutcomes': [{'measure': 'Fraction of participants that reaches therapeutic exposure after 5 days of treatment', 'timeFrame': '5-7 days after initiation of teicoplanin therapy', 'description': 'Unbound teicoplanin exposure after 5 days will be determined and compared to the predefined therapeutic window of 70-150 mg/L\\*24h'}], 'secondaryOutcomes': [{'measure': 'Time until reaching target attainment', 'timeFrame': '5-7 days after initiation of teicoplanin therapy', 'description': 'Time until a participant reaches the therapeutic window will be estimated using the MIPD'}, {'measure': 'Clinical failure', 'timeFrame': '30 days after initiation of teicoplanin therapy', 'description': 'Incidence of clinical failure at day 30. Incidence of clinical failure of teicoplanin treatment will be defined as occurrence of one of the following on day 30:\n\n* Persistent bacteremia\n* Uncontrolled infection at the site of infection by the pathogen for which teicoplanin treatment was started\n* Escalation of therapy\n* Switch of antimicrobial therapy due to lack of effectiveness of teicoplanin'}, {'measure': 'Days in hospital', 'timeFrame': '30 days after initiation of teicoplanin therapy', 'description': 'Total number of days in the hospital'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'Value of TDM for teicoplanin is not well defined. In this single-center low-interventional randomized trial the investigators aim to investigate the superiority of teicoplanin TDM-optimized using Model-Informed-Precision-Dosing (MIPD) of unbound concentrations versus the standard of care (dosing based on antibiotic guidelines) in target attainment.', 'detailedDescription': 'Teicoplanin is a glycopeptide antibiotic that is frequently used in the treatment of gram-positive bacterial infections.\n\nThe glycopeptide antibiotic vancomycin is currently the first choice of treatment against methicillin-resistant Staphylococcus aureus (MRSA), but teicoplanin is found to have a similar efficacy while showing less nephrotoxicity (4.8% vs 10.7%). Vancomycin dosing is based on therapeutic drug monitoring (TDM). In contrast to vancomycin, value of TDM for teicoplanin is not as well defined. In this study the superiority of teicoplanin TDM-optimized dosing using Model-Informed-Precision-Dosing (MIPD) of unbound concentrations versus the standard of care (dosing based on antibiotic guidelines) in target attainment will be investigated. The overall aim of this research is to improve antibiotic treatment with teicoplanin to allow safe and optimal treatment of glycopeptide susceptible strains and to prevent de novo development of resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient is admitted to the ICU, haematology, gastroenterology or orthopaedics department.\n2. The patient is at least 18 years old on the day of inclusion.\n3. The patient is treated with teicoplanin as part of standard care.\n4. The patient or a representative is willing to sign the Informed Consent Form\n\nExclusion Criteria:\n\n1. The patient has previously participated in this study.\n2. The patient receives any form of renal replacement criteria (RRT) other than CVVHD / CVVHDF.\n3. Expected duration of teicoplanin therapy is less than 5 days.\n4. The patient is pregnant'}, 'identificationModule': {'nctId': 'NCT05914467', 'acronym': 'PLATO-3', 'briefTitle': 'TDM-optimized Teicoplanin Dosing Versus Standard of Care', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'A Randomized Trial Investigating the Superiority of TDM-optimized Teicoplanin Dosing Versus Standard of Care', 'orgStudyIdInfo': {'id': '113998'}, 'secondaryIdInfos': [{'id': '2023-503411-15-00', 'type': 'OTHER', 'domain': 'EU CT-number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Participants receive teicoplanin on discretion of the doctor'}, {'type': 'EXPERIMENTAL', 'label': 'Model Informed Precision Dosing (MIPD) guided Therapeutic Drug Monitoring(TDM)', 'description': 'Participants start on standard of care dosing. After 2 days blood samples will be analysed and exposure will be determined using MIPD. Wherever necessary dose adjustments will be made.', 'interventionNames': ['Drug: Teicoplanin']}], 'interventions': [{'name': 'Teicoplanin', 'type': 'DRUG', 'description': 'Dose will be adjusted in the study arm using MIPD guided TDM- dosing', 'armGroupLabels': ['Model Informed Precision Dosing (MIPD) guided Therapeutic Drug Monitoring(TDM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525GA', 'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jaap Mouton', 'role': 'CONTACT', 'email': 'jaap.mouton@radboudumc.nl', 'phone': '+31629698767'}], 'facility': 'RadboudUMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'jaap Mouton', 'role': 'CONTACT', 'email': 'jaap.mouton@radboudumc.nl', 'phone': '0031 24 361 9191'}, {'name': 'Nynke Jager', 'role': 'CONTACT', 'email': 'Nynke.Jager@Radboudumc.nl', 'phone': '0031 24 361 9191'}], 'overallOfficials': [{'name': 'Nynke Jager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud university medical center (Radboudumc)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}