About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
NA
Trial 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.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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)
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)
Exposure Factors Among Mpox Cases
The percentage of cases reporting different exposure factors contributing to mpox transmission. ( Proportion of cases with specific exposure risks)
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)
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Institute of Tropical Medicine, Belgium
Lead sponsor
University of Manitoba
Collaborator
Catholic University of Bukavu, Democratic Republic of Congo
Collaborator
University of Bern
Collaborator
Alliance for International Medical Action
Collaborator
Institut de Recherche pour le Developpement
Collaborator
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Collaborator
European and Developing Countries Clinical Trials Partnership (EDCTP)
Collaborator
University of California, Los Angeles
Collaborator