Population Pharmacokinetics of Amikacin in Neonates

Population Pharmacokinetics of Amikacin in Suspected Cases of Neonatal Sepsis: Multicenter Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04867135

Enrollment

138

Registered

2021-04-30

Start date

2019-12-01

Completion date

2021-09-03

Last updated

2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Sepsis, Late-Onset

Keywords

Neonatal Sepsis, Amikacin, Population Pharmacokinetic, Neonate

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.

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 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. 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. PK/PD profile of amikacin will be evaluated with NONMEM (non-linear mixed effects modelling) software for the analysis.

Interventions

DRUGAmikacin Sulfate Injection

The dose and frequency of amikacin was defined by each hospital.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Days to 1 Months

Inclusion criteria

* Receive at least one dose of Amikacin * Be at least three days old (72 hours)

Exclusion criteria

* Receive the first dose of Amikacin in a healthcare center other than those included in the research * Patient on renal replacement therapy

Design outcomes

Primary

Measure	Time frame	Description
PK/PD targets of amikacin	first dose amikacin (1 day)	Peak Plasma Concentration (Cmax) over 8 fold Minimum Inhibitory Concentration (MIC) or Cmax: 24-35 mg/L
Volume of Distribution (L/Kg) of Amikacin	first dose amikacin (1 day)	The mean population parameter and their interindividual variability in neonates with suspected sepsis
Clearance (L/h) of Amikacin	first dose amikacin (1 day)	The mean population parameter and their interindividual variability in neonates with suspected sepsis

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026