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

NCT06840860 | Recruiting

• 1 other identifier: 1835/24
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Monkeypox (Mpox)

Keywords

Monkeypox; Poxviridae Infections; Democratic Republic of Congo; Infections; Virus Diseases; DNA Virus Infections

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  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)

  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)

  2 years

Secondary Outcomes (11)

• Proportion of Mpox Cases Among Individuals with and without Prior Orthopoxvirus Vaccination

  2 years

• Regional Variability in Clinical Manifestations of Mpox

  2 years

• Regional Variability in Sociodemographic Characteristics of Mpox Cases

  2 years

• Regional Variability in Exposure Factors for Mpox

  2 years

• Regional Variability in Modes of Mpox Transmission

  2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• 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

Study Sites (2)

Masina Mpox Treatment Center

Kinshasa, Masina, Democratic Republic of the Congo

NOT YET RECRUITING

Masina Mpox Treatment Center

Kinshasa, Democratic Republic of the Congo

RECRUITING

Related Publications (1)

• 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.

  PMID: 39892407 BACKGROUND

Related Links

• MBOTE Consortium Website

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood: A maximum 10mL tube blood will be taken by venipuncture from adult participants and children aged 5 and over, while dried blood drops (DBS) will be used for children under 5 and babies. Skin Lesion swab: Skin swabs will be collected following the standard operating procedures of the national program, INRB and CDC recommendations; the base of the lesion is swabbed with a dry sterile flocked nylon swab. A single swab is used for sampling at least two separate lesions in two different locations on the body Oropharyngeal swab: Dry, flocked nylon swabs are used to swab the middle part of the throat, just beyond the tongue

MeSH Terms

Conditions

Mpox, Monkeypox; Poxviridae Infections; Infections; Virus Diseases; DNA Virus Infections

Condition Hierarchy (Ancestors)

Primate Diseases; Animal Diseases; Rodent Diseases

Central Study Contacts

Laurens Liesenborghs, MD, PhD

CONTACT

00000000000; lliesenborghs@itg.be

Sarah Houben, PhD

CONTACT

shouben@itg.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 21, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)