Adverse Drug ReactionsNCT06456086
Effect of Epstein-Barr Virus on Macrophage M2/M1 Migration and EphA2 Expression in Adverse Drug Reactions
An observational study of Adverse Drug Reactions, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adverse Drug Reactions
- What is being tested?
- stimulation with EB virus
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- stimulation with EB virus
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stimulation with EB virusBiological
stimulation with EB virus
| Study group | Role | What they receive |
|---|---|---|
| Stevens-Johnson syndrome/toxic epidermal necrolysis | Not described Receives: Biological: stimulation with EB virus | |
| healthy control group | Not described Receives: Biological: stimulation with EB virus | |
| Maculopapular Eruption | Not described Receives: Biological: stimulation with EB virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the levels of monocytes, macrophages, M2/M1 ratio, and cytokines
Measured: 24 hours and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Dec 2020
- Primary completion31 Mar 2024
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug ReactionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Junting, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456086
- Sponsor's protocol ID
- 2023L88
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epstein-Barr Virus on Macrophage M2/M1 Migration and EphA2 Expression in Adverse Drug Reactions
- ClinicalTrials.gov ID
- NCT06456086
- Acronym / sponsor ID
- 2023L88
- Conditions
- Adverse Drug Reactions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stimulation with EB virusstimulation with EB virus | Biological | Maculopapular Eruption, Stevens-Johnson syndrome/toxic epidermal necrolysis, healthy control group |
Primary outcome
changes in the levels of monocytes, macrophages, M2/M1 ratio, and cytokines
Time frame: 24 hours and 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Reactions, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the levels of monocytes, macrophages, M2/M1 ratio, and cytokines (time frame: 24 hours and 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.