Status:
COMPLETED
Population Pharmacokinetics of Amikacin in Neonates
Lead Sponsor:
Pontificia Universidad Catolica de Chile
Conditions:
Neonatal Sepsis, Late-Onset
Eligibility:
All Genders
3-1 years
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 possibl...
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...
Eligibility Criteria
Inclusion
- Receive at least one dose of Amikacin
- Be at least three days old (72 hours)
Exclusion
- Receive the first dose of Amikacin in a healthcare center other than those included in the research
- Patient on renal replacement therapy
Key Trial Info
Start Date :
December 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 3 2021
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04867135
Start Date
December 1 2019
End Date
September 3 2021
Last Update
April 7 2022
Active Locations (1)
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1
Hospital Clínico UC-Christus
Santiago, Chile, 8330024