The Incidence of Linezolid-induced Thrombocytopenia (LIT) in Critically Ill Patients, the Risk Factors for LIT

The Incidence of Linezolid-induced Thrombocytopenia (LIT) in Critically Ill Patients, the Risk Factors for LIT and Time to Events (LIT, Recovery)

• To identify the incidence of LIT among critically ill patients, as limited studies have only addressed this population.
• To evaluate the impact of several factors on the incidence of LIT, the time to onset of LIT, and the time to recovery of platelets.
• To study the effect of concurrent medications (enoxaparin, unfractinated heparin, piperacillin, carbapenems, tigecycline, fluconazole or voriconazole, digoxin, amiodarone, acetaminophen, tirofiban, statins, and antiepileptics) frequently used in critically ill patients on the incidence of LIT.
• To investigate the impact of possible medications with an antioxidant effect on the prevention of LIT.
• To assess the impact of LIT on composite end point (mortality, bleeding, and length of stay)

Study Overview

• Status: Recruiting
• Conditions: Thrombocytopenia; Drugs
• Intervention / Treatment: Drug: Linezolid 600 mg

• Study Type: Observational
• Enrollment (Estimated): 310

Contacts and Locations

• Study Contact: Name: Amina S Adly, BCPS; Phone Number: 00201559030055; Email: Aminaosamaomar@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • 15 May hospital
    • Contact: Amina S Adly, Diploma; Phone Number: 00201559030055; Email: Aminaosamaomar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult critically ill patients admitted to ICU for different indications

Description

Inclusion Criteria:

• All adult patients, age > or = 18 years old, admitted to the ICU with different indications.
• candidates for intravenous linezolid therapy for > or =1 day.

Exclusion Criteria:

• Taking any myelosuppressive drug.
• Baseline platelets < 50000.
• Patients with hematological malignancy.
• COVID-19 patients.
• Patients with immune thrombocytopenia

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single arm group; Adult critically ill patients admitted to ICU for different indications	Drug: Linezolid 600 mg; Linezolid 600mg injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Linezolid-induced thrombocytopenia (LIT) thrombocytopenia	Defined as platelets < 150000 OR decrease > 50% of baseline platelets.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the onset of LIT	Defined as platelets < 150000 OR decrease > or = 50% of baseline platelets.	One year
time to platelet recovery	after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values	One year
Incidence of clinical outcomes	Incidence of clinical outcomes (bleeding, mortality, length of stay, need for platelet or blood transfusion).	One year

Collaborators and Investigators

• Sponsor: Helwan University
• Investigators: Study Director: Abdelhameed I Ebid, Helwan University, faculty of pharmacy; Study Director: Mahmoud I Mostafa, Helwan University, faculty of pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Thrombocytopenia; Linezolid
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid
• Other Study ID Numbers: 11041989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No