Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
138 participants
OBSERVATIONAL
2019-12-01
2021-09-03
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Amikacin Sulfate Injection
The dose and frequency of amikacin was defined by each hospital.
Interventions
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Amikacin Sulfate Injection
The dose and frequency of amikacin was defined by each hospital.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be at least three days old (72 hours)
Exclusion Criteria
* Patient on renal replacement therapy
3 Days
1 Month
ALL
No
Sponsors
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Pontificia Universidad Catolica de Chile
OTHER
Responsible Party
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Principal Investigators
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Nicolas F Severino, PharmD
Role: PRINCIPAL_INVESTIGATOR
Facultad de Medicina. Pontificia Universidad Católica de Chile
Locations
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Hospital Clínico UC-Christus
Santiago, , Chile
Countries
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References
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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.
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.
Other Identifiers
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190325002
Identifier Type: -
Identifier Source: org_study_id
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