The Incidence of Linezolid-induced Thrombocytopenia (LIT)... | NCT05944445

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

NCT05944445

Sponsor

Helwan University

Status

Unknown status

Last Update Posted

Jul 17, 2023Actual

Enrollment

310Estimated

Phase

Not provided

Conditions

Thrombocytopenia; Drugs

Interventions

Linezolid 600 mg

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 13, 2023Actual

Primary Completion Date

Aug 2024Estimated

Completion Date

Aug 2024Estimated

First Submitted Date

Jul 6, 2023

First Submission Date that Met QC Criteria

Jul 6, 2023

First Posted Date

Jul 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2023

Last Update Posted Date

Jul 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

310Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm group		Adult critically ill patients admitted to ICU for different indications	Drug: Linezolid 600 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Linezolid 600 mg	Drug	Linezolid 600mg injection	Single arm group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Time to the onset of LIT	Defined as platelets < 150000 OR decrease > or = 50% of baseline platelets.	One year
time to platelet recovery	after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult critically ill patients admitted to ICU for different indications

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amina S Adly, BCPS	Contact	00201559030055		Aminaosamaomar@gmail.com

Overall Officials

Name	Affiliation	Role
Abdelhameed I Ebid	Helwan University, faculty of pharmacy	Study Director
Mahmoud I Mostafa	Helwan University, faculty of pharmacy	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
15 May hospital	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013921	Thrombocytopenia

Ancestor Terms

ID	Term
D001791	Blood Platelet Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000095542	Cytopenia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069349	Linezolid

Ancestor Terms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144

Browse Leaves

Not provided

Browse Branches

Not provided