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

Sponsor

Helwan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05944445

Collaborator

(none)

310

Enrollment

Location

12.6

Anticipated Duration (Months)

24.5

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Thrombocytopenia; Drugs	Drug: Linezolid 600 mg

Study Design

Study Type:

Observational

Anticipated Enrollment :

310 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 13, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Single arm group

Adult critically ill patients admitted to ICU for different indications

Drug: Linezolid 600 mg

Linezolid 600mg injection

Outcome Measures

Primary Outcome Measures

Incidence of Linezolid-induced thrombocytopenia (LIT) thrombocytopenia [One year]
Defined as platelets < 150000 OR decrease > 50% of baseline platelets.

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	15 May hospital	Cairo		Egypt

Sponsors and Collaborators

Helwan University

Investigators

Study Director: Abdelhameed I Ebid, Helwan University, faculty of pharmacy
Study Director: Mahmoud I Mostafa, Helwan University, faculty of pharmacy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Abdeltawab, Clinical pharmacist, Helwan University

ClinicalTrials.gov Identifier:

NCT05944445

Other Study ID Numbers:

11041989

First Posted:

Jul 13, 2023

Last Update Posted:

Jul 17, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Mohamed Abdeltawab, Clinical pharmacist, Helwan University

Linezolid

Thrombocytopenia

Additional relevant MeSH terms:

Thrombocytopenia

Linezolid

Study Results

No Results Posted as of Jul 17, 2023