search
Back to results

Efficacy and Safety of Continuous Versus Intermittent Linezolid Infusion in Critically Ill Patients With Septic Shock

Primary Purpose

Treatment Efficacy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Linezolid
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult patients aged > 18 years old diagnosis of septic shock (patient with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial blood pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol\L (>18 mg\dL) in the absence of hypovolemia). positive culture confirming linezolid susceptibility. Exclusion Criteria: Patient refusal. Known allergy to linezolid. Pregnancy and lactation. Severe hepatic failure (Child-Pugh C). Thrombocytopenia (platelet count < 80,000/mm3). Disseminated intravascular coagulation (DIC). Hematologic disease, and concurrent use of other medications that may interact with linezolid (i.e., macrolides, serotonin modulators), or drug-associated thrombocytopenia.

Sites / Locations

  • Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

continuous infusion

intermittent infusion

Arm Description

seventy Patients in the continuous infusion group will receive an intravenous loading dose of 600 mg of Linezolid for 60 min, followed by a continuous infusion of 1200 mg/day (50 mg/h)

seventy patients in the intermittent infusion group will administrate 600 mg of linezolid IV every 12 h for 60 min

Outcomes

Primary Outcome Measures

occurrence of medical cure
primary outcome defined as occurrence of medical cure on day 7 following linezolid initiation. Clinical cure will be indicated as normal body temperature(36.1 C- 37.2C).

Secondary Outcome Measures

secondary outcomes
ICU stay(days) duration of hospital stay (days). duration of linezolid treatment until clinical cure(days). Mortality at the end of treatment, and 30-day mortality.

Full Information

First Posted
February 14, 2023
Last Updated
April 3, 2023
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT05813951
Brief Title
Efficacy and Safety of Continuous Versus Intermittent Linezolid Infusion in Critically Ill Patients With Septic Shock
Official Title
Efficacy and Safety of Continuous Versus Intermittent Linezolid Infusion in Critically Ill Patients With Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
December 2, 2023 (Anticipated)
Study Completion Date
December 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 C&S. 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 1:1 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 mg/day (50 mg/h). 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 × 103/mm3).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled study
Masking
ParticipantCare Provider
Masking Description
. 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.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
continuous infusion
Arm Type
Active Comparator
Arm Description
seventy Patients in the continuous infusion group will receive an intravenous loading dose of 600 mg of Linezolid for 60 min, followed by a continuous infusion of 1200 mg/day (50 mg/h)
Arm Title
intermittent infusion
Arm Type
Active Comparator
Arm Description
seventy patients in the intermittent infusion group will administrate 600 mg of linezolid IV every 12 h for 60 min
Intervention Type
Drug
Intervention Name(s)
Linezolid
Other Intervention Name(s)
zyvox
Intervention Description
linezolid either continues infusion or standard intermittent dose
Primary Outcome Measure Information:
Title
occurrence of medical cure
Description
primary outcome defined as occurrence of medical cure on day 7 following linezolid initiation. Clinical cure will be indicated as normal body temperature(36.1 C- 37.2C).
Time Frame
7 days
Secondary Outcome Measure Information:
Title
secondary outcomes
Description
ICU stay(days) duration of hospital stay (days). duration of linezolid treatment until clinical cure(days). Mortality at the end of treatment, and 30-day mortality.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients aged > 18 years old diagnosis of septic shock (patient with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial blood pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol\L (>18 mg\dL) in the absence of hypovolemia). positive culture confirming linezolid susceptibility. Exclusion Criteria: Patient refusal. Known allergy to linezolid. Pregnancy and lactation. Severe hepatic failure (Child-Pugh C). Thrombocytopenia (platelet count < 80,000/mm3). Disseminated intravascular coagulation (DIC). Hematologic disease, and concurrent use of other medications that may interact with linezolid (i.e., macrolides, serotonin modulators), or drug-associated thrombocytopenia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ibrahim elsherif, MD
Phone
01092286819
Ext
002
Email
dribrahim.elsayed@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed albadry, MD
Phone
01119462809
Ext
002
Email
goldbadry@yahoo.com
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
0060
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ibrahim elsherif, MD
Phone
01092286819
Ext
002
Email
dribrahim.elsayed@med.asu.edu.eg
First Name & Middle Initial & Last Name & Degree
ahmed albadry, MD
Phone
01119462809
Ext
002
Email
goldbadry@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Continuous Versus Intermittent Linezolid Infusion in Critically Ill Patients With Septic Shock

We'll reach out to this number within 24 hrs