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Population Pharmacokinetics of Amikacin in Neonates

NCT04867135 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2022-04-07

No results posted yet for this study

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.

Conditions

  • Neonatal Sepsis, Late-Onset

Interventions

DRUG

Amikacin Sulfate Injection

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

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Nicolas F Severino, PharmD · Facultad de Medicina. Pontificia Universidad Católica de Chile

Eligibility

Min Age
3 Days
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2021-07-31
Completion
2021-09-03

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04867135 on ClinicalTrials.gov