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

NCT05813951 | Unknown DMC

• 1 other identifier: FMASU R235/2022
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Treatment Efficacy

Outcome Measures

Primary Outcomes (1)

• 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).

  7 days

Secondary Outcomes (1)

• secondary outcomes

  30 days

Study Arms (2)

continuous infusion

ACTIVE COMPARATOR

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)

Drug: Linezolid

intermittent infusion

ACTIVE COMPARATOR

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

Drug: Linezolid

Interventions

Linezolid DRUG

linezolid either continues infusion or standard intermittent dose

Also known as: zyvox

continuous infusion; intermittent infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 0060, Egypt

RECRUITING

MeSH Terms

Interventions

Linezolid

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

ibrahim elsherif, MD

CONTACT

01092286819; dribrahim.elsayed@med.asu.edu.eg

ahmed albadry, MD

CONTACT

01119462809; goldbadry@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: . 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: Prospective randomized controlled study

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: April 14, 2023
• Study Start: December 2, 2022
• Primary Completion: December 2, 2023
• Study Completion: December 2, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)