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Completed

NCT Number: NCT04867135

Population Pharmacokinetics of Amikacin in Neonates

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.

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Key information

Conditions

Neonatal Sepsis, Late-Onset Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

3 day–1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico UC-Christus

Santiago, 8330024, Chile

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amikacin Sulfate Injection

Drug

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

Other names: Amikacin

Primary outcomes

  1. Volume of Distribution (L/Kg) of Amikacin

    Time frame: first dose amikacin (1 day)

    The mean population parameter and their interindividual variability in neonates with suspected sepsis

  2. Clearance (L/h) of Amikacin

    Time frame: first dose amikacin (1 day)

    The mean population parameter and their interindividual variability in neonates with suspected sepsis

  3. PK/PD targets of amikacin

    Time frame: first dose amikacin (1 day)

    Peak Plasma Concentration (Cmax) over 8 fold Minimum Inhibitory Concentration (MIC) or Cmax: 24-35 mg/L

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2021
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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