Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-01 @ 1:16 AM
Study NCT ID:
NCT04867135
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2021-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Population Pharmacokinetics of Amikacin in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000583', 'term': 'Amikacin'}], 'ancestors': [{'id': 'D007612', 'term': 'Kanamycin'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of Distribution (L/Kg) of Amikacin', 'timeFrame': 'first dose amikacin (1 day)', 'description': 'The mean population parameter and their interindividual variability in neonates with suspected sepsis'}, {'measure': 'Clearance (L/h) of Amikacin', 'timeFrame': 'first dose amikacin (1 day)', 'description': 'The mean population parameter and their interindividual variability in neonates with suspected sepsis'}, {'measure': 'PK/PD targets of amikacin', 'timeFrame': 'first dose amikacin (1 day)', 'description': 'Peak Plasma Concentration (Cmax) over 8 fold Minimum Inhibitory Concentration (MIC) or Cmax: 24-35 mg/L'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonatal Sepsis', 'Amikacin', 'Population Pharmacokinetic', 'Neonate'], 'conditions': ['Neonatal Sepsis, Late-Onset']}, 'referencesModule': {'references': [{'pmid': '15606440', 'type': 'BACKGROUND', 'citation': 'Lingvall M, Reith D, Broadbent R. The effect of sepsis upon gentamicin pharmacokinetics in neonates. Br J Clin Pharmacol. 2005 Jan;59(1):54-61. doi: 10.1111/j.1365-2125.2005.02260.x.'}, {'pmid': '19305985', 'type': 'BACKGROUND', 'citation': 'Sherwin CM, Svahn S, Van der Linden A, Broadbent RS, Medlicott NJ, Reith DM. Individualised dosing of amikacin in neonates: a pharmacokinetic/pharmacodynamic analysis. Eur J Clin Pharmacol. 2009 Jul;65(7):705-13. doi: 10.1007/s00228-009-0637-4. Epub 2009 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'Aminoglycosides such as Amikacin are routinely used in newborns for the treatment of neonatal sepsis due to gram-negative bacilli. Despite the frequency of this indication, it has not yet been possible to establish definitive dosage schedules that ensure effectiveness and low risk of toxicity, due to the high pharmacokinetic variability observed in this population.\n\nIn addition to anthropometric variables, evidence from retrospective studies suggests that sepsis could be capable of significantly modifying the pharmacokinetics of aminoglycosides in neonates, but the investigators suggest conducting prospective studies of higher methodological quality to verify this hypothesis.\n\nDue to the lack of pharmacokinetic and pharmacodynamic (PK / PD) studies of Amikacin in this group of patients, the investigators have raised the need to develop a prospective observational study; describing a PK / PD model of amikacin in newborns with suspected sepsis.', 'detailedDescription': 'Three blood samples will be taken from each of the 138 participants. As a standard of care, a sample will always be taken at 0.5h (Cmax) after the first dose and a sample before the second dose, which can be at 24h, 36h, or 48h as per physician indication. The third sample will be collected according to what has been assigned by a block randomization method, in one of the following moments: 1, 2, 4, 8, 12 or 18 hours after the administration of the first dose of Amikacin.\n\nThe methods used to analyze the samples will be: Particle Enhanced Turbidimetric Immunoassay (PETIA), Architect C8000; and Homogeneous Microparticle Immunoassay in Solution (KIMS), Roche systems. The determination of the susceptibility and minimum Inhibitory Concentration (MIC) will be carried out by the laboratories of each hospital by agar dilution method.\n\nPK/PD profile of amikacin will be evaluated with NONMEM (non-linear mixed effects modelling) software for the analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '3 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to neonatal intensive care units of two hospitals of high-complexity in Chile', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receive at least one dose of Amikacin\n* Be at least three days old (72 hours)\n\nExclusion Criteria:\n\n* Receive the first dose of Amikacin in a healthcare center other than those included in the research\n* Patient on renal replacement therapy'}, 'identificationModule': {'nctId': 'NCT04867135', 'briefTitle': 'Population Pharmacokinetics of Amikacin in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Population Pharmacokinetics of Amikacin in Suspected Cases of Neonatal Sepsis: Multicenter Study', 'orgStudyIdInfo': {'id': '190325002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Sepsis / Sepsis', 'description': 'To compare amikacin PK / PD models of newborns with a confirmed diagnosis of sepsis (clinical or microbiological) and with ruled out sepsis.', 'interventionNames': ['Drug: Amikacin Sulfate Injection']}], 'interventions': [{'name': 'Amikacin Sulfate Injection', 'type': 'DRUG', 'otherNames': ['Amikacin'], 'description': 'The dose and frequency of amikacin was defined by each hospital.', 'armGroupLabels': ['No Sepsis / Sepsis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8330024', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Clínico UC-Christus', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Nicolas F Severino, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Facultad de Medicina. Pontificia Universidad Católica de Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}