Effect of Epstein-Barr Virus on Macrophage M2/M1 Migratio... | NCT06456086

Studies
Effect of Epstein-Barr Virus on Macrophage M2/M1 Migration and EphA2 Expression in Adverse Drug Reactions

NCT06456086

Sponsor

First Affiliated Hospital of Kunming Medical University

Status

Unknown status

Last Update Posted

Jun 13, 2024Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Adverse Drug Reactions

Interventions

stimulation with EB virus

Countries

China

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

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Mar 31, 2024Actual

Completion Date

Oct 31, 2024Estimated

First Submitted Date

Jun 7, 2024

First Submission Date that Met QC Criteria

Jun 7, 2024

First Posted Date

Jun 13, 2024Actual

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

Jun 7, 2024

Last Update Posted Date

Jun 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to investigate the effect of EBV reactivation or EBV reactivation added with dexamethasone(DXM) in patients with adverse drug reactions(CDR) , through evaluating the levels on monocyte, macrophage M2/M1 and cytokines. To investigate whether expression of EBV receptors EphA2 could specifically influence on EBV activation in CDRs. We performed a prospective longitudinal study on the frequencies of Monocyte, Macrophage, M2/M1 and cytokines included IL-4,IL-13,TNF-α,IFN-γ,IFN-β, CXCL9 and CXCL10 after onset of MPE ,SJS/TEN and control groups. PBMCs collected from peripheral blood were cocultured with EBV or EBV with DXM. We next examined whether EBV or EBV with DXM could have a strong impact on the MOs, Mac, M2/M1 and cytokines and which cytokines could be crucial for the interaction between M2/M1 and EBV, by in vitro cocultures. Finally, EphA2 were detected to evaluate reactivation of EBV.

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

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stevens-Johnson syndrome/toxic epidermal necrolysis			Biological: stimulation with EB virus
healthy control group			Biological: stimulation with EB virus
Maculopapular Eruption			Biological: stimulation with EB virus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stimulation with EB virus	Biological	stimulation with EB virus	Maculopapular Eruption Stevens-Johnson syndrome/toxic epidermal necrolysis healthy control group

Measure	Description	Time Frame
changes in the levels of monocytes, macrophages, M2/M1 ratio, and cytokines		24 hours and 48 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age and Gender: The study includes male and female patients aged 18 years and older.
a.Erythema Multiforme (MPE) Patients: Diagnosed based on clinical presentation and medical examination findings.b.Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) Patients: Diagnosed according to the criteria set by the International Dermatology Society for SJS or TEN.c.Control Group: Healthy volunteers, without any history of chronic disease or acute infection, and not currently on any medications.

Exclusion Criteria:

Other Chronic Diseases: Patients with active heart, liver, kidney disease, or other systemic conditions.
Acute Infection: Patients who have had a viral or bacterial infection within the month prior to enrollment.
Immune Status: Patients who are immunocompromised or are receiving immunosuppressive therapy.
Allergy History: Patients with a known allergy to any drugs or agents used in the study.
Pregnancy or Lactation: Women who are currently pregnant or breastfeeding.

Accepts Healthy Volunteers

Yes

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

Erythema Multiforme (MPE) Patients: Diagnosed based on clinical presentation and medical examination findings.or
Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) Patients: Diagnosed according to the criteria set by the International Dermatology Society for SJS or TEN.or
Control Group: Healthy volunteers, without any history of chronic disease or acute infection, and not currently on any medications.

Sampling Method

Non-Probability Sample