Clinical trial

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

Name
2023L88
Description
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.
Trial arms
Trial start
2020-12-01
Estimated PCD
2024-03-31
Trial end
2024-10-31
Status
Active (not recruiting)
Treatment
stimulation with EB virus
stimulation with EB virus
Arms:
Maculopapular Eruption, Stevens-Johnson syndrome/toxic epidermal necrolysis, healthy control group
Size
27
Primary endpoint
changes in the levels of monocytes, macrophages, M2/M1 ratio, and cytokines
24 hours and 48 hours
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 27, 'type': 'ACTUAL'}}
Updated at
2024-06-13

1 organization

1 product

1 indication