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NCT Number: NCT06840860

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

This study aims to better understand how mpox is spreading in the DRC, how it affects different groups of people, and how well vaccines protect against it. The study is designed as a cross-sectional survey, meaning researchers will collect and analyze data from patients diagnosed with mpox at a single point in time. It will also use a case-control approach, comparing people who test positive for the virus to those who test negative, to identify risk factors and evaluate the effectiveness of the vaccine.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Masina Mpox Treatment Center, Kinshasa, Masina, Democratic Republic of the Congo

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About this study

This study aims to better understand how mpox is spreading in the DRC, how it affects different groups of people, and how well vaccines protect against it. The study is designed as a cross-sectional survey, meaning researchers will collect and analyze data from patients diagnosed with mpox at a single point in time. It will also use a case-control approach, comparing people who test positive for the virus to those who test negative, to identify risk factors and evaluate the effectiveness of the vaccine.

The study is being conducted by Institut National de Recherche Biomédicale (INRB) in collaboration with several international partners, including the Institute of Tropical Medicine (ITM) in Belgium, Johns Hopkins University, the University of Manitoba, Médecins Sans Frontières (MSF), and other leading research institutions. The study is funded by organizations such as the European & Developing Countries Clinical Trials Partnership (EDCTP3) and the Belgian Federal Government.

The study will be carried out in the DRC, focusing on provinces that have been hit hardest by mpox outbreaks, including North Kivu, South Kivu, Maniema, Kinshasa, and Equateur. Participants will be recruited from hospitals and health centers that provide mpox testing and care.

What Will Happen During the Study?

  • People with suspected mpox who come to a hospital or health center for testing will be invited to participate.
  • Participants will answer questions about their symptoms, medical history, and possible exposure to the virus, including vaccination status.
  • Biological samples (blood, throat swabs, and skin lesion swabs) will be collected and analyzed for mpox and other infections such as measles or chickenpox.
  • Hospitalized patients will have additional data recorded about their recovery.

Key Study Goals

  • Describe how mpox affects people in different parts of the DRC, including symptoms, risk factors, and how the virus spreads.
  • Compare differences between two types of the virus (clades Ia and Ib) to understand whether one is more severe than the other.
  • Assess the effectiveness of the mpox vaccine by comparing vaccination rates between infected and uninfected individuals.
  • Identify risk factors for severe disease, complications, and death in mpox patients.
  • Investigate co-infections (e.g., with measles or chickenpox) that might worsen the disease.
  • Support mpox treatment and prevention efforts by training healthcare workers and improving real-time data sharing through an online platform.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • NA

Treatment and study plan

Primary outcomes

  1. Clinical Manifestations of Mpox

    Time frame: 2 years

    The frequency and distribution of clinical symptoms and disease severity in confirmed mpox cases. (Percentage of cases presenting each symptom (e.g., fever, rash, lymphadenopathy)

  2. Sociodemographic Characteristics of Confirmed Mpox Cases

    Time frame: 2 years

    The distribution of age, gender, occupation, and other demographic characteristics of confirmed mpox cases. (Mean/median values for continuous variables (e.g., age in years) and proportions for categorical variables (e.g., gender distribution, occupation)

  3. Exposure Factors Among Mpox Cases

    Time frame: 2 years

    The percentage of cases reporting different exposure factors contributing to mpox transmission. ( Proportion of cases with specific exposure risks)

  4. Modes of Transmission of Mpox

    Time frame: 2 years

    The relative contribution of different modes of transmission to the spread of mpox in the studied population. (Proportion of cases attributed to specific transmission routes)

Secondary outcomes

  1. Proportion of Mpox Cases Among Individuals with and without Prior Orthopoxvirus Vaccination

    Time frame: 2 years

    This measure assesses the protective effect of prior vaccination against mpox by comparing vaccination coverage among PCR-confirmed cases versus unconfirmed suspected cases in a test-negative case-control study. The primary metric is the odds ratio (OR) of prior vaccination among cases versus controls, with vaccine efficacy (VE) calculated as VE = 1 - OR.

  2. Regional Variability in Clinical Manifestations of Mpox

    Time frame: 2 years

    Comparison of the frequency and distribution of clinical symptoms and disease severity in confirmed mpox cases across different regions of the DRC.

  3. Regional Variability in Sociodemographic Characteristics of Mpox Cases

    Time frame: 2 years

    Comparison of sociodemographic factors such as age, gender, occupation, and household composition among confirmed mpox cases in different regions.

  4. Regional Variability in Exposure Factors for Mpox

    Time frame: 2 years

    Comparison of reported exposure factors (e.g., human contact, animal exposure) among mpox cases in different regions of the DRC.

  5. Regional Variability in Modes of Mpox Transmission

    Time frame: 2 years

    Comparison of the distribution of transmission modes in different regions, identifying dominant transmission pathways.

  6. Differences in Clinical Symptoms Between Mpox Clades Ia and Ib

    Time frame: 2 years

    The frequency of clinical symptoms will be compared between infections caused by Clade Ia and Clade Ib, based on genomic sequencing data.

  7. Comparison of Disease Severity Between Mpox Clades Ia and Ib

    Time frame: 2 years

    The severity of mpox disease will be assessed and compared between Clade Ia and Clade Ib infections. Severity classification will follow standardized clinical definitions.

  8. Comparison of Mpox Transmission Routes Between Clade Ia and Clade Ib Cases

    Time frame: 2 years

    Transmission modes will be compared between cases of Clade Ia and Clade Ib to identify potential differences in transmission dynamics.

  9. Risk Factors for Severe Mpox Outcomes, Including Hospitalization and Mortality

    Time frame: 2 years

    This measure evaluates predictors of severe disease, including underlying comorbidities, demographic risk factors, and exposure history. It analyzes hospitalization rates, complications, and case fatality rates among mpox-positive patients.

  10. Proportion of Mpox Cases with Co-infections Detected by PCR

    Time frame: 2 years

    This measure determines the prevalence of co-infections (e.g., measles, varicella, bacterial infections) among confirmed mpox cases, using PCR testing for other viral pathogens.

  11. Estimating the Risk of Complications and Mortality in Mpox Cases

    Time frame: 2 years

    This measure quantifies the proportion of confirmed mpox cases that develop complications or result in fatality. A multivariate analysis will be conducted to identify independent predictors of severe disease progression.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurens Liesenborghs, MD, PhD

CONTACT

[email protected]

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Sarah Houben, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Alliance for International Medical Action
  • Catholic University of Bukavu, Democratic Republic of Congo
  • European and Developing Countries Clinical Trials Partnership (EDCTP)
  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
  • Institut de Recherche pour le Developpement
  • University of Bern
  • University of California, Los Angeles
  • University of Manitoba

Registry information

Official study title

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

Acronym: MBOTE-EPIC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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