Actively Recruiting

All Genders
ID06840860

Monkeypox Biology, Outcome, Transmission and Epidemiology (MBOTE) Study: Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)

Led by Institute of Tropical Medicine, Belgium · Updated on 2025-05-02

1000

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Institute of Tropical Medicine, Belgium

Lead Sponsor

U

University of Manitoba

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how monkeypox (mpox) spreads in the Democratic Republic of Congo (DRC), how it affects different groups of people, and how well vaccines protect against it. This observational study uses a cross-sectional survey design, collecting data from patients diagnosed with mpox at one point in time, and a case-control approach comparing those who test positive to those who test negative to find risk factors and vaccine effectiveness. The study is conducted by the Institut National de Recherche Biomédicale and international partners, focusing on provinces heavily affected by mpox outbreaks. Participants with suspected mpox who visit hospitals or health centers for testing will be invited to join the study. They will answer questions about symptoms, medical history, exposure to the virus, and vaccination status. Biological samples such as blood, throat swabs, and skin lesion swabs will be collected to test for mpox and other infections like measles or chickenpox. Hospitalized patients will have additional data recorded about their recovery. During the study, researchers will collect clinical and sociodemographic information, exposure factors, and transmission modes of mpox. They will compare infection rates between vaccinated and unvaccinated people and examine differences between two virus types. The study also tracks co-infections and risk factors for severe disease or death. Data will help train healthcare workers and improve real-time sharing on an online platform. The study will run for two years, assessing many health and transmission outcomes related to mpox.

CONDITIONS

Brief Title

Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Apply to be tested for VMPX at HGR or another test center.
  • Patients of all ages and sexes. However, minors under the age of 12 are excluded from questions on sex life.
  • The patient or his/her culturally acceptable representative is willing and able to give informed consent for participation in the study.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single point in time

Participants diagnosed with mpox or testing negative will provide information about their symptoms, medical history, and exposure to the virus, and biological samples will be collected for analysis.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants will be observed over time to understand the clinical manifestations, transmission, and outcomes of mpox.

Follow-up assessments as appropriate

Trial Site Locations

Total: 2 locations

1

Masina Mpox Treatment Center

Kinshasa, Masina, Democratic Republic of the Congo

Not Yet Recruiting

2

Masina Mpox Treatment Center

Kinshasa, Democratic Republic of the Congo

Actively Recruiting

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Research Team

L

Laurens Liesenborghs, MD, PhD

S

Sarah Houben, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Frequently Asked Questions

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Published Research Related To This Trial

Epidemiological and clinical features of mpox during the clade Ib outbreak in South Kivu, Democratic Republic of the Congo: a prospective cohort study.

Isabel Brosius, Emmanuel Hasivirwe Vakaniaki, Guy Mukari...

https://pubmed.ncbi.nlm.nih.gov/39892407