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

NCT05944445 | Unknown FDA Drug

• 1 other identifier: 11041989
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

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)

Conditions

Thrombocytopenia; Drugs

Keywords

Linezolid; Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Incidence of Linezolid-induced thrombocytopenia (LIT) thrombocytopenia

  Defined as platelets \< 150000 OR decrease \> 50% of baseline platelets.

  One year

Secondary Outcomes (3)

• Time to the onset of LIT

  One year

• time to platelet recovery

  One year

• Incidence of clinical outcomes

  One year

Study Arms (1)

Single arm group

Adult critically ill patients admitted to ICU for different indications

Drug: Linezolid 600 mg

Interventions

Linezolid 600 mg DRUG

Linezolid 600mg injection

Single arm group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult critically ill patients admitted to ICU for different indications

You may qualify if:

• All adult patients, age \> or = 18 years old, admitted to the ICU with different indications.
• candidates for intravenous linezolid therapy for \> or =1 day.

You may not qualify if:

• Taking any myelosuppressive drug.
• Baseline platelets \< 50000.
• Patients with hematological malignancy.
• COVID-19 patients.
• Patients with immune thrombocytopenia

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

15 May hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Abdelhameed I Ebid

  Helwan University, faculty of pharmacy

  STUDY DIRECTOR

• Mahmoud I Mostafa

  Helwan University, faculty of pharmacy

  STUDY DIRECTOR

Central Study Contacts

Amina S Adly, BCPS

CONTACT

00201559030055; Aminaosamaomar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 13, 2023
• Study Start: July 13, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

EG (1)