Population Pharmacokinetics of Amikacin in Neonates
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| ClinicalTrials.gov Identifier: NCT04867135 |
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Recruitment Status :
Recruiting
First Posted : April 30, 2021
Last Update Posted : April 30, 2021
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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 they 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, we have raised the need to develop a prospective observational study; describing a PK / PD model of amikacin in newborns with suspected sepsis.
| Condition or disease | Intervention/treatment |
|---|---|
| Neonatal Sepsis, Late-Onset | Drug: Amikacin Sulfate Injection |
Three blood samples will be taken from each of the 138 patients. 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.
| Study Type : | Observational |
| Estimated Enrollment : | 138 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Population Pharmacokinetics of Amikacin in Suspected Cases of Neonatal Sepsis: Multicenter Study |
| Actual Study Start Date : | December 1, 2019 |
| Estimated Primary Completion Date : | July 31, 2021 |
| Estimated Study Completion Date : | July 31, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Drug: Amikacin Sulfate Injection
The dose and frequency of amikacin was defined by each hospital.
Other Name: Amikacin |
- 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
- 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
- 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
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| Ages Eligible for Study: | up to 1 Month (Child) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04867135
| Contact: Nicolas F Severino, PharmD | +56223453193 | nseverin@med.puc.cl | |
| Contact: Maria Soledad Urzúa, MD | +56223453224 | soleurzua@gmail.com |
| Chile | |
| Hospital Clínico UC-Christus | Recruiting |
| Santiago, Chile, 8330024 | |
| Contact: Nicolas F Severino, PharmD +56223543193 nseverin@med.puc.cl | |
| Contact: Maria Soledad Urzúa, MD +56223543224 soleurzua@gmail.com | |
| Principal Investigator: | Nicolas F Severino, PharmD | Facultad de Medicina. Pontificia Universidad Católica de Chile |
| Responsible Party: | Pontificia Universidad Catolica de Chile |
| ClinicalTrials.gov Identifier: | NCT04867135 |
| Other Study ID Numbers: |
190325002 |
| First Posted: | April 30, 2021 Key Record Dates |
| Last Update Posted: | April 30, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Neonatal Sepsis Amikacin Population Pharmacokinetic Neonate |
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Sepsis Neonatal Sepsis Infections Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Infant, Newborn, Diseases Amikacin Anti-Bacterial Agents Anti-Infective Agents |