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

Thrombocytopenia; Drugs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944445
• Other study ID #: 11041989
• Status: Recruiting
• Start date: July 13, 2023
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Helwan University
• Contact: Amina S Adly, BCPS
• Phone: 00201559030055
• Email: Aminaosamaomar[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytopenia; Drugs

Intervention

Drug:
• Linezolid 600 mg
Linezolid 600mg injection

Locations

Country	Name	City	State
Egypt	15 May hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Linezolid-induced thrombocytopenia (LIT) thrombocytopenia	Defined as platelets < 150000 OR decrease > 50% of baseline platelets.	One year
Secondary	Time to the onset of LIT	Defined as platelets < 150000 OR decrease > or = 50% of baseline platelets.	One year
Secondary	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
Secondary	Incidence of clinical outcomes	Incidence of clinical outcomes (bleeding, mortality, length of stay, need for platelet or blood transfusion).	One year