Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Monkeypox (Mpox). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Democratic Republic of the Congo
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Monkeypox Biology, Outcome, Transmission and Epidemiology (MBOTE) Study: Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)
Overview
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.
Primary outcome measures
- Clinical Manifestations of Mpox [Time frame: 2 years]
- Sociodemographic Characteristics of Confirmed Mpox Cases [Time frame: 2 years]
- Exposure Factors Among Mpox Cases [Time frame: 2 years]
- Modes of Transmission of Mpox [Time frame: 2 years]
Secondary outcome measures (11)
- Proportion of Mpox Cases Among Individuals with and without Prior Orthopoxvirus Vaccination [Time frame: 2 years]
- Regional Variability in Clinical Manifestations of Mpox [Time frame: 2 years]
- Regional Variability in Sociodemographic Characteristics of Mpox Cases [Time frame: 2 years]
- Regional Variability in Exposure Factors for Mpox [Time frame: 2 years]
- Regional Variability in Modes of Mpox Transmission [Time frame: 2 years]
- Differences in Clinical Symptoms Between Mpox Clades Ia and Ib [Time frame: 2 years]
- Comparison of Disease Severity Between Mpox Clades Ia and Ib [Time frame: 2 years]
- Comparison of Mpox Transmission Routes Between Clade Ia and Clade Ib Cases [Time frame: 2 years]
- Risk Factors for Severe Mpox Outcomes, Including Hospitalization and Mortality [Time frame: 2 years]
- Proportion of Mpox Cases with Co-infections Detected by PCR [Time frame: 2 years]
- Estimating the Risk of Complications and Mortality in Mpox Cases [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Democratic Republic of the Congo · 2 centers
- Masina Mpox Treatment Center — Kinshasa
- Masina Mpox Treatment Center — Kinshasa
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-B PMID 39892407
Identifiers
NCT: NCT06840860 · 1835/24