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

June 7, 2024 updated by: Tang Junting, First Affiliated Hospital of Kunming Medical University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Tang Junting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
healthy control group
Biological: stimulation with EB virus
stimulation with EB virus
Stevens-Johnson syndrome/toxic epidermal necrolysis
Biological: stimulation with EB virus
stimulation with EB virus
Maculopapular Eruption
Biological: stimulation with EB virus
stimulation with EB virus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
changes in the levels of monocytes, macrophages, M2/M1 ratio, and cytokines
Time Frame: 24 hours and 48 hours
24 hours and 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Kunming Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023L88

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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