Clinical trial NCT06456086: Effect of Epstein-Barr Virus on Macrophage M2/M1 Migration and EphA2 Expression in Adverse Drug Reactions
Official title: Effect of Epstein-Barr Virus on Macrophage M2/M1 Migration and EphA2 Expression in Adverse Drug Reactions
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adverse Drug Reactions
Lead sponsor: First Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: changes in the levels of monocytes, macrophages, M2/M1 ratio, and cytokines
timeFrame: 24 hours and 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Tang Junting
state: Yunnan
Study officials:
References: