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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06840860
Acronym
MBOTE-EPIC
Enrollment
1000
Registered
2025-02-21
Start date
2025-03-28
Completion date
2027-02-28
Last updated
2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monkeypox (Mpox)

Keywords

Monkeypox, Poxviridae Infections, Democratic Republic of Congo, Infections, Virus Diseases, DNA Virus Infections

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Manifestations of Mpox2 yearsThe frequency and distribution of clinical symptoms and disease severity in confirmed mpox cases. (Percentage of cases presenting each symptom (e.g., fever, rash, lymphadenopathy)
Sociodemographic Characteristics of Confirmed Mpox Cases2 yearsThe 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)
Exposure Factors Among Mpox Cases2 yearsThe percentage of cases reporting different exposure factors contributing to mpox transmission. ( Proportion of cases with specific exposure risks)
Modes of Transmission of Mpox2 yearsThe 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

MeasureTime frameDescription
Regional Variability in Sociodemographic Characteristics of Mpox Cases2 yearsComparison of sociodemographic factors such as age, gender, occupation, and household composition among confirmed mpox cases in different regions.
Regional Variability in Exposure Factors for Mpox2 yearsComparison of reported exposure factors (e.g., human contact, animal exposure) among mpox cases in different regions of the DRC.
Comparison of Disease Severity Between Mpox Clades Ia and Ib2 yearsThe severity of mpox disease will be assessed and compared between Clade Ia and Clade Ib infections. Severity classification will follow standardized clinical definitions.
Differences in Clinical Symptoms Between Mpox Clades Ia and Ib2 yearsThe frequency of clinical symptoms will be compared between infections caused by Clade Ia and Clade Ib, based on genomic sequencing data.
Risk Factors for Severe Mpox Outcomes, Including Hospitalization and Mortality2 yearsThis 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.
Proportion of Mpox Cases with Co-infections Detected by PCR2 yearsThis measure determines the prevalence of co-infections (e.g., measles, varicella, bacterial infections) among confirmed mpox cases, using PCR testing for other viral pathogens.
Estimating the Risk of Complications and Mortality in Mpox Cases2 yearsThis 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.
Comparison of Mpox Transmission Routes Between Clade Ia and Clade Ib Cases2 yearsTransmission modes will be compared between cases of Clade Ia and Clade Ib to identify potential differences in transmission dynamics.
Regional Variability in Modes of Mpox Transmission2 yearsComparison of the distribution of transmission modes in different regions, identifying dominant transmission pathways.
Proportion of Mpox Cases Among Individuals with and without Prior Orthopoxvirus Vaccination2 yearsThis 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.
Regional Variability in Clinical Manifestations of Mpox2 yearsComparison of the frequency and distribution of clinical symptoms and disease severity in confirmed mpox cases across different regions of the DRC.

Countries

Democratic Republic of the Congo

Contacts

Primary ContactLaurens Liesenborghs, MD, PhD
lliesenborghs@itg.be00000000000
Backup ContactSarah Houben, PhD
shouben@itg.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026