Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05813951
Study type Interventional
Source Ain Shams University
Contact ibrahim elsherif, MD
Phone 01092286819
Email dribrahim.elsayed@med.asu.edu.eg
Status Recruiting
Phase N/A
Start date December 2, 2022
Completion date December 2, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04508803 - Combination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer Phase 2
Completed NCT05087381 - Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community Phase 4
Active, not recruiting NCT02551523 - Early Simplified: A Trial to Compare the Efficacy of Standard of Care Combination Antiretroviral Therapy With a Simplified Dolutegravir Monotherapy in Patients With a Primary HIV-1 Infection Phase 2
Recruiting NCT06221722 - Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation
Terminated NCT03503968 - TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms Phase 1/Phase 2
Not yet recruiting NCT06460883 - Effects of Eccentric Banded Leg Curls Versus Eccentric Cable Leg Curls Exercises in Cricket Players N/A
Completed NCT02572947 - A Pilot Study of MONOtherapy of DOlutegravir in HIV-1 Virologically Suppressed Patients Phase 2
Completed NCT05144295 - Lubiprostone for Functional Constipation in the Under 18 Years Patients Phase 3
Completed NCT03345160 - Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study Phase 2