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

NCT ID: NCT05944445

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-13

Study Completion Date

2024-08-31

Brief Summary

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* 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

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Conditions

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Thrombocytopenia; Drugs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Single arm group

Adult critically ill patients admitted to ICU for different indications

Linezolid 600 mg

Intervention Type DRUG

Linezolid 600mg injection

Interventions

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Linezolid 600 mg

Linezolid 600mg injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helwan University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Abdeltawab

Clinical pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdelhameed I Ebid

Role: STUDY_DIRECTOR

Helwan University, faculty of pharmacy

Mahmoud I Mostafa

Role: STUDY_DIRECTOR

Helwan University, faculty of pharmacy

Locations

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15 May hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amina S Adly, BCPS

Role: CONTACT

00201559030055

Facility Contacts

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Amina S Adly, Diploma

Role: primary

00201559030055

Other Identifiers

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11041989

Identifier Type: -

Identifier Source: org_study_id

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