Epidemiological and Clinical Characteristics of Mpox Outbreak in Equateur, the DR Congo (Part1)
NCT ID: NCT07055867
Last Updated: 2025-07-09
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
122 participants
OBSERVATIONAL
2024-08-01
2025-12-31
Brief Summary
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* What are the clinical features of the 2024 mpox outbreak in Equateur Province of DRC?
* What are the associated risk factors of the 2024 mpox outbreak? Participants which has mpox like symptoms will answer mpox investigations related questions and be collected skin lesions and whole blood samples.
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Detailed Description
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Over the past five decades, routine smallpox vaccination ceased worldwide, resulting in waning herd immunity against orthopoxviruses. During this period, mpox incidence rose markedly, with an estimated tenfold increase in global cases. Two principal genetic clades of MPXV have been identified: clade I (historically referred to as the Congo Basin clade) and clade II (the West African clade). In 2018, Nigeria experienced a resurgence of mpox, highlighting the virus's potential to emerge in previously controlled areas. Starting in 2022, clade II mpox circulated globally, especially among men who have sex with men (MSM), peaking in mid-2022 before declining to persistently lower levels by early 2023. Although clade II mpox typically exhibits a low case-fatality ratio (\<1%), clade I has historically been associated with more severe disease and higher mortality. In 2023, the number of reported mpox cases continued to climb in the DRC, prompting the World Health Organization (WHO) to declare a Public Health Emergency of International Concern (PHEIC) in August 2024.
Recent surveillance indicates that sub-clade Ia MPXV is spreading in western DRC through multiple transmission modes, including contact with infected wild animals, household exposure, or sexual contact. By contrast, sub-clade Ib mpox in the eastern part of the country appears initially to spread via intimate or sexual contact between adults, followed by household transmission. Numerous environmental and social risk factors-including the consumption of rodent species, deforestation, climate change, civil unrest, population displacement, emerging MPXV variants, and weakened immunity-may be driving mpox incidence. Clade Ia mpox is currently affecting western parts of the DRC, yet the epidemiology remains poorly understood due to the limited number of laboratory-confirmed cases.
This study aims to characterize the clinical features of the 2024 mpox outbreak in Equateur Province of DRC and to identify associated risk factors. The findings will advance understanding of mpox transmission dynamics and disease severity, ultimately informing more effective prevention and control strategies in endemic settings.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case
Cases are defined as Individuals who reported to local health agents with symptoms consistent with mpox and subsequently tested positive for mpox through a molecular-based diagnostic test.
No interventions assigned to this group
Control
Controls are defined as Individuals who reported to local health agents with symptoms consistent with mpox but subsequently tested negative for mpox through a molecular-based diagnostic test. Among individuals with a negative molecular diagnostic test for mpox, those who have passed more than 21 days since the onset of mpox-like signs and symptoms or those whom serological testing confirms prior exposure to mpox will be excluded as controls from analysis to avoid confounding results.
Rationale: It is not possible to reliably distinguish between uninfected individuals and convalescents. Previous studies suggest a median recovery time of approximately 21 days.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
• Fulfillment of the current mpox clinical case definition in the DRC, which includes: Presence of a vesicular or pustular eruption with deep-seated, firm pustules.
At least one of the following symptoms:
Fever preceding the eruption. Lymphadenopathy (inguinal, axillary, or cervical). Presence of pustules or crusts on the palms of the hands or soles of the feet. • Laboratory confirmation: At least one molecular-based mpox diagnostic test confirming the diagnosis.
Exclusion Criteria
• Refusal to participate in the study: Individuals who decline to provide consent for study participation will be excluded.
ALL
No
Sponsors
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Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
OTHER
Osaka Metropolitan University
OTHER
Responsible Party
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Yasutoshi KIDO
Professor
Principal Investigators
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Yasutoshi Kido, Professor
Role: PRINCIPAL_INVESTIGATOR
Osaka Metropolitan Unievrsity
Locations
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Equateur Provincial Public Health Laboratory
Mbandaka, Équateur Province, Democratic Republic of the Congo
Countries
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References
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Li Z, Sinha A, Zhang Y, Tanner N, Cheng HT, Premsrirut P, Carlow CKS. Extraction-free LAMP assays for generic detection of Old World Orthopoxviruses and specific detection of Mpox virus. Sci Rep. 2023 Nov 30;13(1):21093. doi: 10.1038/s41598-023-48391-z.
Mazzotta V, Nozza S, Lanini S, Moschese D, Tavelli A, Rossotti R, Fusco FM, Biasioli L, Matusali G, Raccagni AR, Mileto D, Maci C, Lapadula G, Di Biagio A, Pipito L, Tamburrini E, Monforte AD, Castagna A, Antinori A; mpox-Icona study group. Clinical and laboratory predictors of mpox severity and duration: an Italian multicentre cohort study (mpox-Icona). EBioMedicine. 2024 Sep;107:105289. doi: 10.1016/j.ebiom.2024.105289. Epub 2024 Aug 22.
Osadebe L, Hughes CM, Shongo Lushima R, Kabamba J, Nguete B, Malekani J, Pukuta E, Karhemere S, Muyembe Tamfum JJ, Wemakoy Okitolonda E, Reynolds MG, McCollum AM. Enhancing case definitions for surveillance of human monkeypox in the Democratic Republic of Congo. PLoS Negl Trop Dis. 2017 Sep 11;11(9):e0005857. doi: 10.1371/journal.pntd.0005857. eCollection 2017 Sep.
Ozasa K, Fukushima W. Commentary: Test-Negative Design Reduces Confounding by Healthcare-Seeking Attitude in Case-Control Studies. J Epidemiol. 2019 Aug 5;29(8):279-281. doi: 10.2188/jea.JE20180177. Epub 2018 Nov 10. No abstract available.
Moraes-Cardoso I, Benet S, Carabelli J, Perez-Zsolt D, Mendoza A, Rivero A, Alemany A, Descalzo V, Alarcon-Soto Y, Grifoni A, Sette A, Molto J, Marc A, Marks M, Mitja O, Brander C, Paredes R, Izquierdo-Useros N, Carrillo J, Suner C, Olvera A, Mothe B; MoViE-Immune study group. Immune responses associated with mpox viral clearance in men with and without HIV in Spain: a multisite, observational, prospective cohort study. Lancet Microbe. 2024 Aug;5(8):100859. doi: 10.1016/S2666-5247(24)00074-0. Epub 2024 Jun 7.
CLINICAL MANAGEMENT AND INFECTION PREVENTION AND CONTROL FOR MONKEYPOX. 2022 https://iris.who.int/bitstream/handle/10665/355798/WHO-MPX-Clinical_and_IPC-2022.1-eng.pdf?sequence=1 (accessed Dec 7, 2024).
Vakaniaki EH, Kacita C, Kinganda-Lusamaki E, O'Toole A, Wawina-Bokalanga T, Mukadi-Bamuleka D, Amuri-Aziza A, Malyamungu-Bubala N, Mweshi-Kumbana F, Mutimbwa-Mambo L, Belesi-Siangoli F, Mujula Y, Parker E, Muswamba-Kayembe PC, Nundu SS, Lushima RS, Makangara-Cigolo JC, Mulopo-Mukanya N, Pukuta-Simbu E, Akil-Bandali P, Kavunga H, Abdramane O, Brosius I, Bangwen E, Vercauteren K, Sam-Agudu NA, Mills EJ, Tshiani-Mbaya O, Hoff NA, Rimoin AW, Hensley LE, Kindrachuk J, Baxter C, de Oliveira T, Ayouba A, Peeters M, Delaporte E, Ahuka-Mundeke S, Mohr EL, Sullivan NJ, Muyembe-Tamfum JJ, Nachega JB, Rambaut A, Liesenborghs L, Mbala-Kingebeni P. Sustained human outbreak of a new MPXV clade I lineage in eastern Democratic Republic of the Congo. Nat Med. 2024 Oct;30(10):2791-2795. doi: 10.1038/s41591-024-03130-3. Epub 2024 Jun 13.
WHO Director-General declares mpox outbreak a public health emergency of international concern. Saudi Med J. 2024 Aug;45(9):1002-1003. No abstract available.
Besombes C, Mbrenga F, Malaka C, Gonofio E, Schaeffer L, Konamna X, Selekon B, Namsenei-Dankpea J, Gildas Lemon C, Landier J, von Platen C, Gessain A, Manuguerra JC, Fontanet A, Nakoune E. Investigation of a mpox outbreak in Central African Republic, 2021-2022. One Health. 2023 Jun;16:100523. doi: 10.1016/j.onehlt.2023.100523. Epub 2023 Mar 7.
Ladnyj ID, Ziegler P, Kima E. A human infection caused by monkeypox virus in Basankusu Territory, Democratic Republic of the Congo. Bull World Health Organ. 1972;46(5):593-7.
Thornhill JP, Barkati S, Walmsley S, Rockstroh J, Antinori A, Harrison LB, Palich R, Nori A, Reeves I, Habibi MS, Apea V, Boesecke C, Vandekerckhove L, Yakubovsky M, Sendagorta E, Blanco JL, Florence E, Moschese D, Maltez FM, Goorhuis A, Pourcher V, Migaud P, Noe S, Pintado C, Maggi F, Hansen AE, Hoffmann C, Lezama JI, Mussini C, Cattelan A, Makofane K, Tan D, Nozza S, Nemeth J, Klein MB, Orkin CM; SHARE-net Clinical Group. Monkeypox Virus Infection in Humans across 16 Countries - April-June 2022. N Engl J Med. 2022 Aug 25;387(8):679-691. doi: 10.1056/NEJMoa2207323. Epub 2022 Jul 21.
Other Identifiers
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N553/BN/PMMF/2024
Identifier Type: -
Identifier Source: org_study_id
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