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

NCT06456086 | Active Not Recruiting

• 1 other identifier: 2023L88
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Drug Reactions

Outcome Measures

Primary Outcomes (1)

• changes in the levels of monocytes, macrophages, M2/M1 ratio, and cytokines

  24 hours and 48 hours

Study Arms (3)

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

stimulation with EB virus BIOLOGICAL

stimulation with EB virus

Maculopapular Eruption; Stevens-Johnson syndrome/toxic epidermal necrolysis; healthy control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Erythema Multiforme (MPE) Patients: Diagnosed based on clinical presentation and medical examination findings.or 2. 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 3. Control Group: Healthy volunteers, without any history of chronic disease or acute infection, and not currently on any medications.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

Tang Junting

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: December 1, 2020
• Primary Completion: March 31, 2024
• Study Completion: October 31, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

CN (1)