Epidemiological and Clinical Characteristics of Mpox Outbreak in Equateur, the DR Congo (Part1)

NCT07055867 | Enrolling By Invitation

• 1 other identifier: N553/BN/PMMF/2024
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to characterize the clinical features of the 2024 mpox outbreak in Equateur Province of DRC and to identify associated risk factors. The main question it aims to answer is:

• 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.

Conditions

Mpox (Monkeypox)

Keywords

test negative control; case control; outbreak investigation; Mpox

Outcome Measures

Primary Outcomes (4)

• Mpox positivity

  Mpox positivity is determined based on one or more molecular-based diagnostic tests. In addition to standard diagnostic methods, the study will assess the performance of novel diagnostic platforms, such as loop-mediated isothermal amplification (LAMP) assays. These platforms will be evaluated for sensitivity, specificity, and overall diagnostic accuracy compared to established molecular-based techniques.

  Day 1

• Virological Course

  Genotypes and longitudinal changes in viral load (measured as copies/mL) will be monitored over multiple time points during the study period. Genotypes and quantitative viral load dynamics will reflect disease progression and the timeline of viral clearance, providing insights into the natural course of infection.

  Day1 and 3-4 weeks after baseline

• Disease outcome

  Mpox severity will be evaluated based on skin lesion burden, clinical complications, organ dysfunction, and mortality outcomes. Scoring Criteria: Mild: Fewer than 25 lesions. Moderate: 26-99 lesions. Severe: 100 or more lesions or the presence of organ dysfunction, regardless of lesion count. Fatal Outcome: If a patient dies from mpox or its complications during the study, the case will be classified as "fatal outcome." Assessment: The severity score will integrate the number of skin lesions across various anatomical sites and documented signs of complications (e.g., respiratory distress, neurological symptoms, renal impairment).

  Day1 and 3-4 weeks after baseline

• Serological Response

  The serological response will be assessed through the detection and quantification of mpox-specific antibodies(Arbitrary Unit) at different time points. Evaluate the kinetics of the humoral immune response during and after infection. Determine correlations between serological responses, disease severity, and virological clearance.

  Day1 and 3-4 weeks after baseline

Secondary Outcomes (2)

• Performance of Novel Diagnostic Platforms

  Day 1

• Clinical Recovery

  3-4 weeks after baseline

Study Arms (2)

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.

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.

Eligibility Criteria

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

Study Population

This study targets patients reported as suspected mpox cases (all ages, both sexes) to the Health District Central Office in the selected sites. For participants aged under 15 years or those with impaired communication abilities (e.g., due to altered consciousness or severe medical conditions), consent must be obtained from a parent, legal guardian, or responsible caregiver. The study population is designed to minimize selection bias related to health-seeking behavior. All patients suspected of having mpox and who provide proxy-assisted written informed consent to participate in the study are eligible for inclusion due to reduction of the risk of contact transmission with verbal agreement documented and confirmed by a witness. This approach prioritizes participant and staff safety while adhering to ethical standards.

You may qualify if:

• Provision of informed consent: Proxy-assisted informed consent is allowed under safety considerations. Following oral consent, the investigator will document this on the informed consent form as a witness.
• 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.

You may not qualify if:

• Participants will be excluded from the study under the following conditions:
• Refusal to participate in the study: Individuals who decline to provide consent for study participation will be excluded.

Sponsors & Collaborators

• Osaka Metropolitan University: lead
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator

Study Sites (1)

Equateur Provincial Public Health Laboratory

Mbandaka, Équateur Province, Democratic Republic of the Congo

Location

Related Publications (11)

• 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.

  PMID: 38036581 BACKGROUND

• 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.

  PMID: 39178746 BACKGROUND

• 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.

  PMID: 28892474 BACKGROUND

• 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.

  PMID: 30416164 BACKGROUND

• 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.

  PMID: 38857615 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 38871006 BACKGROUND

• 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.

  PMID: 39218470 BACKGROUND

• 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.

  PMID: 36950196 BACKGROUND

• 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.

  PMID: 4340218 BACKGROUND

• 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.

  PMID: 35866746 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Skin lesion and oral mucosa swab sample

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Yasutoshi Kido, Professor

  Osaka Metropolitan Unievrsity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: July 9, 2025
• Study Start: August 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

DE (1)