NCT04867135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2021

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2021

Enrollment Period

1.7 years

First QC Date

April 27, 2021

Last Update Submit

March 29, 2022

Conditions

Neonatal Sepsis, Late-Onset

Keywords

Neonatal SepsisAmikacinPopulation PharmacokineticNeonate

Outcome Measures

Primary Outcomes (3)

  • Volume of Distribution (L/Kg) of Amikacin

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

    first dose amikacin (1 day)

  • Clearance (L/h) of Amikacin

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

    first dose amikacin (1 day)

  • PK/PD targets of amikacin

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

    first dose amikacin (1 day)

Study Arms (1)

No Sepsis / Sepsis

To compare amikacin PK / PD models of newborns with a confirmed diagnosis of sepsis (clinical or microbiological) and with ruled out sepsis.

Drug: Amikacin Sulfate Injection

Interventions

Amikacin Sulfate InjectionDRUG

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

Also known as: Amikacin
No Sepsis / Sepsis

Eligibility Criteria

Age3 Days - 1 Month
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to neonatal intensive care units of two hospitals of high-complexity in Chile

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico UC-Christus

Santiago, 8330024, Chile

Location

Related Publications (2)

  • 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: 15606440BACKGROUND

  • 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.

    PMID: 19305985BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Amikacin

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

KanamycinAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Nicolas F Severino, PharmD

    Facultad de Medicina. Pontificia Universidad Católica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 30, 2021

Study Start

December 1, 2019

Primary Completion

July 31, 2021

Study Completion

September 3, 2021

Last Updated

April 7, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)