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

NCT ID: NCT05813951

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2023-12-02

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).

Conditions

Treatment Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

continuous infusion

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)

Group Type: ACTIVE_COMPARATOR

Linezolid

Intervention Type: DRUG

linezolid either continues infusion or standard intermittent dose

intermittent infusion

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

Group Type: ACTIVE_COMPARATOR

Linezolid

Intervention Type: DRUG

linezolid either continues infusion or standard intermittent dose

Interventions

Linezolid

linezolid either continues infusion or standard intermittent dose

Intervention Type: DRUG

Other Intervention Names

zyvox

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Elsayed

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

ibrahim elsherif, MD

Role: CONTACT

dribrahim.elsayed@med.asu.edu.eg

01092286819 ext. 002

ahmed albadry, MD

Role: CONTACT

goldbadry@yahoo.com

01119462809 ext. 002

Facility Contacts

ibrahim elsherif, MD

Role: primary

dribrahim.elsayed@med.asu.edu.eg

01092286819 ext. 002

ahmed albadry, MD

Role: backup

goldbadry@yahoo.com

01119462809 ext. 002

Other Identifiers

FMASU R235/2022

Identifier Type: -

Identifier Source: org_study_id