Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813951
Status:
RECRUITING
Last Update Posted:
2023-04-14
First Post:
2023-02-14
Brief Title:
Efficacy and Safety of Continuous Versus Intermittent Linezolid Infusion in Critically Ill Patients With Septic Shock
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Efficacy and Safety of Continuous Versus Intermittent Linezolid Infusion in Critically Ill Patients With Septic Shock
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 aim of study is this to evaluate the efficacy and safety of continuous linezolid infusion versus the standard regimen in treating critically ill patients with septic shock in the ICU
Detailed Description:
it is Prospective randomized controlled study on One hundred forty patients to evaluate the efficacy and safety of continuous linezolid infusion versus the standard regimen in treating critically ill patients with septic shock in the ICU Initially each patient will be evaluated for septic shock based on the clinical criteria Baseline microbiologic specimens will be obtained for all recruited patients through the day of diagnosis including blood CS Then empirical treatment with antibiotics according to expected source of sepsis Patients with Gram-positive cultures sensitive to Linezolid will be randomly allocated to receive Linezolid in the continuous infusion group Group A or conventional intermittent infusion group Group B in a 11 ratio
Group A seventy Patients in the continuous infusion group will receive an intravenous loading dose of 600 mg for 60 min followed by a continuous infusion of 1200 mgday 50 mgh
Group B seventy patients in the intermittent infusion group will administrate 600 mg of linezolid IV every 12 h for 60 min
The treatment period will be 8-10 days in both groups but might decrease or increase based on the patients clinical response At the beginning of the study simple randomization will be used to assign patients using the random numbers set offered by the ICU coordinator Each patient will be assigned a randomized code consisting of two letters that indicate the intensive care unit and two digits indicating the randomization sequence
The end point of the study is occurrence of thrombocytopenia decrease in platelet count 50 from baseline or a decrease in platelet count 100 103mm3
Group A seventy Patients in the continuous infusion group will receive an intravenous loading dose of 600 mg for 60 min followed by a continuous infusion of 1200 mgday 50 mgh
Group B seventy patients in the intermittent infusion group will administrate 600 mg of linezolid IV every 12 h for 60 min
The treatment period will be 8-10 days in both groups but might decrease or increase based on the patients clinical response At the beginning of the study simple randomization will be used to assign patients using the random numbers set offered by the ICU coordinator Each patient will be assigned a randomized code consisting of two letters that indicate the intensive care unit and two digits indicating the randomization sequence
The end point of the study is occurrence of thrombocytopenia decrease in platelet count 50 from baseline or a decrease in platelet count 100 103mm3
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?:
False
Is an FDA AA801 Violation?:
None