Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867135
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2021-04-27
Brief Title:
Population Pharmacokinetics of Amikacin in Neonates
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Population Pharmacokinetics of Amikacin in Suspected Cases of Neonatal Sepsis Multicenter Study
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
In 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
Due 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
In 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
Due 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
Detailed Description:
Three blood samples will be taken from each of the 138 participants As a standard of care a sample will always be taken at 05h 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
The 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
PKPD profile of amikacin will be evaluated with NONMEM non-linear mixed effects modelling software for the analysis
The 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
PKPD profile of amikacin will be evaluated with NONMEM non-linear mixed effects modelling software for the analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None