NCT05944445

Unknown

The Incidence of Linezolid-induced Thrombocytopenia (LIT) in...

Helwan University Source

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Other study identifiers

Sponsor study identifier

11041989

Study Type

observational

Estimated enrollment

310

Locations

1 country

Sites

1

Timeline

Study Start

July 13, 2023

Actual (reported)

Primary Completion

August 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

August 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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)

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 310 participants
Study completion date: August 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
July 6, 2023
Actual (reported)
First Posted
July 13, 2023
Actual (reported)
Study Start
July 13, 2023
Actual (reported)
Primary Completion
August 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: July 17, 2023
Status Verified: July 2023
Last Update Submitted: July 13, 2023

Conditions

Thrombocytopenia; Drugs

Keywords

LinezolidThrombocytopenia

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 mgDrug

Linezolid 600mg injection

Single arm group

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Helwan University
Otherlead

Study Sites (1)

15 May hospital

Cairo, Egypt

RECRUITING

Amina S Adly, DiplomaCONTACT00201559030055 Aminaosamaomar@gmail.com

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinones

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

Actual (reported)

Primary Completion

August 2024

Estimated (date passed)

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Phase 2Completed

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Time To Efficacy and Onset Of Action Of Linezolid

Phase 4Completed

NCT01544673

Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Males

Phase 1Completed

NCT01564758

Post Marketing Surveillance Study on Linezolid

Completed

NCT00255996

Evaluation Of Linezolid Pk Profile In Burns Patients

Phase 1Completed

NCT03841721

Linezolid in Healthy Volunteers

Phase 1Unknown

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

Contact the study team to confirm eligibility.

Oxazoles

Azoles

Heterocyclic Compounds, 1-Ring

Heterocyclic Compounds

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

August 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

July 17, 2023

Record last verified: 2023-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05944445
Data provider: ClinicalTrials.gov
Source updated: 2023-07-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:32 UTC

Locations

EG(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Single arm group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations