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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05944445

Enrollment

310

Registered

2023-07-13

Start date

2023-07-13

Completion date

2024-08-31

Last updated

2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia; Drugs

Keywords

Linezolid, Thrombocytopenia

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)

Interventions

DRUGLinezolid 600 mg

Linezolid 600mg injection

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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).

Countries

Egypt

Contacts

Primary ContactAmina S Adly, BCPS

Aminaosamaomar@gmail.com00201559030055

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026