Clinical trial NCT06840860: Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)
Official title: Monkeypox Biology, Outcome, Transmission and Epidemiology (MBOTE) Study: Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Monkeypox (Mpox)
Keywords: Monkeypox
Poxviridae Infections
Democratic Republic of Congo
Infections
Virus Diseases
DNA Virus Infections
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: University of Manitoba
name: Catholic University of Bukavu, Democratic Republic of Congo
name: University of Bern
name: Alliance for International Medical Action
name: Institut de Recherche pour le Developpement
name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: European and Developing Countries Clinical Trials Partnership (EDCTP)
name: University of California, Los Angeles
First posted: 2025-02-21
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: Clinical Manifestations of Mpox
timeFrame: 2 years
measure: Sociodemographic Characteristics of Confirmed Mpox Cases
timeFrame: 2 years
measure: Exposure Factors Among Mpox Cases
timeFrame: 2 years
measure: Modes of Transmission of Mpox
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of Mpox Cases Among Individuals with and without Prior Orthopoxvirus Vaccination
timeFrame: 2 years
measure: Regional Variability in Clinical Manifestations of Mpox
timeFrame: 2 years
measure: Regional Variability in Sociodemographic Characteristics of Mpox Cases
timeFrame: 2 years
measure: Regional Variability in Exposure Factors for Mpox
timeFrame: 2 years
measure: Regional Variability in Modes of Mpox Transmission
timeFrame: 2 years
measure: Differences in Clinical Symptoms Between Mpox Clades Ia and Ib
timeFrame: 2 years
measure: Comparison of Disease Severity Between Mpox Clades Ia and Ib
timeFrame: 2 years
measure: Comparison of Mpox Transmission Routes Between Clade Ia and Clade Ib Cases
timeFrame: 2 years
measure: Risk Factors for Severe Mpox Outcomes, Including Hospitalization and Mortality
timeFrame: 2 years
measure: Proportion of Mpox Cases with Co-infections Detected by PCR
timeFrame: 2 years
measure: Estimating the Risk of Complications and Mortality in Mpox Cases
timeFrame: 2 years
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Masina Mpox Treatment Center
state: Masina
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Masina Mpox Treatment Center
Study officials:
References:
citation: 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.