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

Adverse Drug Reactions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06456086
• Other study ID #: 2023L88
• Status: Active, not recruiting
• Start date: December 1, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2024
• Source: First Affiliated Hospital of Kunming Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: October 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age and Gender: The study includes male and female patients aged 18 years and older.

2. 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:

1. Other Chronic Diseases: Patients with active heart, liver, kidney disease, or other systemic conditions.

2. Acute Infection: Patients who have had a viral or bacterial infection within the month prior to enrollment.

3. Immune Status: Patients who are immunocompromised or are receiving immunosuppressive therapy.

4. Allergy History: Patients with a known allergy to any drugs or agents used in the study.

5. Pregnancy or Lactation: Women who are currently pregnant or breastfeeding.

Related Conditions & MeSH terms

• Adverse Drug Reactions
• Drug-Related Side Effects and Adverse Reactions
• Epstein-Barr Virus Infections

Intervention

Biological:
• stimulation with EB virus
stimulation with EB virus

Locations

Country	Name	City	State
China	Tang Junting	Kunming	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Kunming Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the levels of monocytes, macrophages, M2/M1 ratio, and cytokines		24 hours and 48 hours