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

Recruiting

• Conditions: Thrombocytopenia; Drugs
• Interventions: Drug: Linezolid 600 mg

• Registration Number: NCT05944445
• Lead Sponsor: Helwan University

Brief Summary

* 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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-06
• Study Start: 2023-07-13
• Study First Posted: 2023-07-13
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 310

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm group	Linezolid 600 mg	Adult critically ill patients admitted to ICU for different indications

Primary Outcome Measures

Name	Time	Method
Incidence of Linezolid-induced thrombocytopenia (LIT) thrombocytopenia	One year	Defined as platelets \< 150000 OR decrease \> 50% of baseline platelets.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

15 May hospital; 🇪🇬 Cairo, Egypt