An observational study in Monkeypox (Mpox), sponsored by Institute of Tropical Medicine, Belgium. Recruiting at 2 sites in Congo, The Democratic Republic of the. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by Institute of Tropical Medicine, Belgium · Observational
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.
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?
Key Study Goals
Institute of Tropical Medicine, Belgium is the lead sponsor of 103 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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)
Time frame: 2 years
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)
Time frame: 2 years
Exposure Factors Among Mpox Cases
The percentage of cases reporting different exposure factors contributing to mpox transmission. ( Proportion of cases with specific exposure risks)
Time frame: 2 years
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)
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
Regional Variability in Modes of Mpox Transmission
Comparison of the distribution of transmission modes in different regions, identifying dominant transmission pathways.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
Plan to share: No
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Mpox (monkeypox)
Institute of Tropical Medicine, Belgium