Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05801484
Status:
RECRUITING
Last Update Posted:
2023-04-06
First Post:
2022-11-15
Brief Title:
Pharmacokinetics and Pharmacodynamics of Linezolid Continuous and Intermittent Administration
Sponsor:
Cluj Municipal Clinical Hospital
Organization:
Cluj Municipal Clinical Hospital
Study Overview
Official Title:
Continuous Infusion Versus Intermittent Administration of Linezolid - Impact on Clinical Outcome and Adverse Reactions in Critically Ill Patients a Pharmacokinetic and Pharmacodynamic Prospective Study
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the therapeutic efficacy expressed in pharmacokineticpharmacodynamic PKPD indices the clinical response and the risk of adverse reactions following the continuous and intermittent administration of linezolid in critical patients in the Intensive Care Unit
Subject inclusion criteria
A minimum of 30 subjects in each group will be included in the study in accordance with the study inclusion criteria
patients hospitalized in the intensive care unit
female or male sex
age over 18 years
linezolid is prescribed by the attending physician in empirical or targeted treatment
Exclusion criteria
Patients who have documented severe liver failure Child-Pugh C score Patients who refuse to sign the informed consent
Subject inclusion criteria
A minimum of 30 subjects in each group will be included in the study in accordance with the study inclusion criteria
patients hospitalized in the intensive care unit
female or male sex
age over 18 years
linezolid is prescribed by the attending physician in empirical or targeted treatment
Exclusion criteria
Patients who have documented severe liver failure Child-Pugh C score Patients who refuse to sign the informed consent
Detailed Description:
The clinical study will be conducted in accordance with the protocol approved by the Ethics Commission of the IHaĊ£ieganu University of Medicine and Pharmacy and the Ethics Commission of the Municipal Clinical Hospital from Cluj-Napoca in accordance with the rules of good clinical study practice
The study will take place on the Intensive Care Unit of University Clinical Municipal Hospital from Cluj-Napoca Romania The analysis of blood drug concentration will be carried out at University of Medicine and Pharmacy Iuliu Hatieganu Pharmacokinetics and Biopharmacy Laboratory from Cluj-Napoca Romania
The objectives of the study are
Determination and the comparison of the pharmacokinetic and pharmacodynamic parameters of linezolid administration following intermittent infusion or continuous infusion in critically ill patients
Determination of the minimum inhibitory concentrations MIC for linezolid for the identified bacteria Staphylococcus aureus Coagulase-Negative Staphylococcus Enterococcus spp Streptococcus pneumoniae
The study will be conducted in the ICU Department of the Municipal Clinical Hospital in Cluj-Napoca Romania following an open prospective randomized design with two groups of patients group with intermittent infusion and group with continuous infusion of the same daily dose of linezolid The patients that will be included in each group will be the patients in need of intensive care who are prescribed linezolid by the attending physician as empirical or targeted therapy
Given the low light stability of the linezolid solution the infusion bag will be protected with an opaque cover provided by the manufacturer throughout the infusion period The administration will be carried out with the help of an infusomate
The duration of the therapy will be established for each patient by the attending physician depending on the type location and severity of the infection in accordance with the recommendations of the therapeutic guidelines
Throughout the duration of the study the subjects will receive the treatment according to the recommendations of the attending physician regardless of the group they belong to the only difference between the groups refers to the type of infusion used to administer linezolid
Blood samples 10 samples will be taken from each volunteer according to the following schedule immediately before the start of the infusion T0 and at 1 2 4 8 12 18 24 36 48 hours from initiation of drug infusion Then a single daily sample will be taken until the end of the treatment Blood samples will be used to determine plasma concentrations of linezolid
The efficacy and safety of the treatment will be evaluated using clinical and paraclinical data which will be correlated with the pharmacokinetic parameters determined for each type of treatment continuous infusion or intermittent infusion The data will be recorded in a case report form without disclosing the identity of the patients each patient will receive a code at the beginning of the study
Each subject will be followed until discharge or a maximum of 30 days after initiation of therapy
The study will take place on the Intensive Care Unit of University Clinical Municipal Hospital from Cluj-Napoca Romania The analysis of blood drug concentration will be carried out at University of Medicine and Pharmacy Iuliu Hatieganu Pharmacokinetics and Biopharmacy Laboratory from Cluj-Napoca Romania
The objectives of the study are
Determination and the comparison of the pharmacokinetic and pharmacodynamic parameters of linezolid administration following intermittent infusion or continuous infusion in critically ill patients
Determination of the minimum inhibitory concentrations MIC for linezolid for the identified bacteria Staphylococcus aureus Coagulase-Negative Staphylococcus Enterococcus spp Streptococcus pneumoniae
The study will be conducted in the ICU Department of the Municipal Clinical Hospital in Cluj-Napoca Romania following an open prospective randomized design with two groups of patients group with intermittent infusion and group with continuous infusion of the same daily dose of linezolid The patients that will be included in each group will be the patients in need of intensive care who are prescribed linezolid by the attending physician as empirical or targeted therapy
Given the low light stability of the linezolid solution the infusion bag will be protected with an opaque cover provided by the manufacturer throughout the infusion period The administration will be carried out with the help of an infusomate
The duration of the therapy will be established for each patient by the attending physician depending on the type location and severity of the infection in accordance with the recommendations of the therapeutic guidelines
Throughout the duration of the study the subjects will receive the treatment according to the recommendations of the attending physician regardless of the group they belong to the only difference between the groups refers to the type of infusion used to administer linezolid
Blood samples 10 samples will be taken from each volunteer according to the following schedule immediately before the start of the infusion T0 and at 1 2 4 8 12 18 24 36 48 hours from initiation of drug infusion Then a single daily sample will be taken until the end of the treatment Blood samples will be used to determine plasma concentrations of linezolid
The efficacy and safety of the treatment will be evaluated using clinical and paraclinical data which will be correlated with the pharmacokinetic parameters determined for each type of treatment continuous infusion or intermittent infusion The data will be recorded in a case report form without disclosing the identity of the patients each patient will receive a code at the beginning of the study
Each subject will be followed until discharge or a maximum of 30 days after initiation of therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None