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Monkeypox (Mpox)MBOTE-EPICNCT06840860

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

An observational study of Monkeypox (Mpox), run by Institute of Tropical Medicine, Belgium at 2 sites in Democratic Republic of the Congo.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Monkeypox (Mpox)
How many people
1,000 participants
Where
2 sitesDemocratic Republic of the Congo
Study dates
28 Mar 2025to 28 Feb 2027
How long will I take part?
10 Days
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study will take place in the DRC, in the provinces most affected by mpox in recent months, namely North Kivu, South Kivu, Maniema, Kinshasa and Equateur. The study could be extended to other provinces, depending on the dynamics of the epidemic and research needs. Participants will be recruited from general referral hospitals (HGR) and from referral health centers (CSR) or health centers (CS) in the most affected areas, which provide mpox screening and management services.

Who may be able to join

  • 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.

Who cannot join

  • NA

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laurens Liesenborghs, MD, PhD contact

00000000000

lliesenborghs@itg.be

Sarah Houben, PhD contact

shouben@itg.be

Democratic Republic of the Congo2 sites, 2 recruiting

  • Masina Mpox Treatment Center

    Kinshasa, Masina

    Sabin Sabiti, MD, PhD, sabitisabin2024@gmail.com

    Not yet recruiting

  • Masina Mpox Treatment Center

    Kinshasa

    Recruiting

Other trials in Democratic Republic of the Congo

About this study

Official title: Monkeypox Biology, Outcome, Transmission and Epidemiology (MBOTE) Study: 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.

Read the 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.
Keywords
Monkeypox, Poxviridae Infections, Democratic Republic of Congo, Infections, Virus Diseases, DNA Virus Infections
Medical subject headings
Mpox, Monkeypox, Poxviridae Infections, Infections, Virus Diseases, DNA Virus Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Manifestations of Mpox

    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)

    Measured: 2 years

  2. Sociodemographic Characteristics of Confirmed Mpox Cases

    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)

    Measured: 2 years

  3. Exposure Factors Among Mpox Cases

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

    Measured: 2 years

  4. Modes of Transmission of Mpox

    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)

    Measured: 2 years

Secondary outcomes (11)

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

    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.

    Measured: 2 years

  2. Regional Variability in Clinical Manifestations of Mpox

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

    Measured: 2 years

  3. Regional Variability in Sociodemographic Characteristics of Mpox Cases

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

    Measured: 2 years

  4. Regional Variability in Exposure Factors for Mpox

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

    Measured: 2 years

  5. Regional Variability in Modes of Mpox Transmission

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

    Measured: 2 years

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

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

    Measured: 2 years

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

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

    Measured: 2 years

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

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

    Measured: 2 years

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

    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.

    Measured: 2 years

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

    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.

    Measured: 2 years

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

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start28 Mar 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
10 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06840860
Sponsor's protocol ID
1835/24
Acronym
MBOTE-EPIC
Status last verified
Apr 2025
First submitted
10 Feb 2025
Last updated
2 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brosius I, Vakaniaki EH, Mukari G, Munganga P, Tshomba JC, De Vos E, Bangwen E, Mujula Y, Tsoumanis A, Van Dijck C, Alengo A, Mutimbwa-Mambo L, Kumbana FM, Munga JB, Mambo DM, Zangilwa JW, Kitwanda SB, Houben S, Hoff NA, Makangara-Cigolo JC, Kinganda-Lusamaki E, Peeters M, Rimoin AW, Kindrachuk J, Low N, Katoto PDMC, Malembaka EB, Amuasi JH, Tshiani-Mbaya O, Kambaji DM, Kojan R, Kacita C, Mukadi-Bamuleka D, Ahuka-Mundeke S, Vercauteren K, Wawina-Bokalanga T, Muyembe-Tamfum JJ, Nundu SS, Liesenborghs L, Mbala-Kingebeni P. Epidemiological and clinical features of mpox during the clade Ib outbreak in South Kivu, Democratic Republic of the Congo: a prospective cohort study. Lancet. 2025 Feb 15;405(10478):547-559. doi: 10.1016/S0140-6736(25)00047-9. Epub 2025 Jan 29.

    PubMed 39892407

Questions about this trial

What is this clinical trial studying?

An observational study of Monkeypox (Mpox), run by Institute of Tropical Medicine, Belgium at 2 sites in Democratic Republic of the Congo.

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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Democratic Republic of the Congo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laurens Liesenborghs, MD, PhD (00000000000, lliesenborghs@itg.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Manifestations of Mpox (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06840860, which also lists 1 linked publication.

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 2 May 2025.

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