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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInstitute of Tropical Medicine, Belgium

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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)

Time frame
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)

Time frame
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)

Time frame
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)

Time frame
2 years

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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