NCT04867993: Amicool

Amikacin Pharmacokinetics to Optimize Dosing Recommendations and Patho(Physiological) Considerations in Neonates With Perinatal Asphyxia Treated With Hypothermia

Status unknown NA Last updated 27 April 2021

What this trial tests

NA trial testing Amikacin in Asphyxia Neonatorum in 80 participants. Status unknown.

Timeline

28 August 2018

Primary endpoint
1 August 2022

1 December 2022

Quick facts

Lead sponsor	University of Sarajevo
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	28 August 2018
Primary completion	1 August 2022
Estimated completion	1 December 2022
Sites	1 location across Bosnia and Herzegovina

Drugs / interventions tested

• Amikacin (AMIKACIN) — full drug profile →

Conditions studied

• Asphyxia Neonatorum — all drugs for Asphyxia Neonatorum →

Sponsor

University of Sarajevo

Who can join

Under 1 Day, any sex, with Asphyxia Neonatorum. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Maximum Plasma Concentration [Cmax]
  Time frame: 5 years
  the first plasma concentration measured after the dosing
• Minimum Plasma concentration (Ctrough)
  Time frame: 5 years
  the last plasma concentration measured after the dosing
• Area under the plasma concentration versus time curve (AUC)
  Time frame: 5 years
  Area under the plasma concentration versus time curve calculated based on a trapezoidal rule
• Clearance (CL)
  Time frame: 5 years
  Clearance of the drug, seen from the last part of the concentration-time curve
• Volume of distribution (Vd)
  Time frame: 5 years
  Volume of distribution of the drug, seen from the early part of the concentration-time curve
• Minumum inhibitory concentration (MIC 90)
  Time frame: 5 years
  concentration of the drug needed to inhibit the growth of 90% of isolates

Sponsor's own description

As a part of a project on perinatal clinical pharmacology, the primary aim of the present project is to study amikacin pharmacokinetics (PK) and physiology in asphyxiated neonates treated with therapeutic hypothermia and to provide amikacin dosing recommendations, which will be validated prospectively. For this purpose, we aim to first collect retrospective data on amikacin available in neonates treated with hypothermia in the neonatal intensive care unit (NICU)s in Leuven and Amsterdam, and consequently to propose the dosing regimen to be used in the prospective amikacin PK study at our NICU in University Clinical Center (UCC) Sarajevo. At our NICU we aim to collect amikacin PK observations and other covariates in at least 40 neonates while treated with hypothermia and after re-warming period (a paired analysis), and in asphyxiated neonates not treated with hypothermia (control group).

We hereby will use a stepwise approach, as initially used to develop and to validate an amikacin dosing regimen in preterm and term neonates (De Cock RFW et al., 2012, Smits A et al, 2015).

A 3-step approach will be used, of which different parts will be conducted in different contributing hospitals:

1. Retrospective evaluation of amikacin therapeutic drug monitoring (TDM) in asphyxiated neonates treated with hypothermia (University hospital Leuven, VUmc Amsterdam)
2. Development of population PK model derived amikacin dosing recommendation
3. Prospective PK study with validation of the new dosing regimen (UCC Sarajevo, UCC Tuzla)

Publications & conference data

No peer-reviewed publications indexed yet for this trial.