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

FMASU R235/2022

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

2022-12-02

2023-12-02

2023-12-02

Recruiting

140

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized controlled study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '. 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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

2023-04-14