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Mpox (Monkeypox)NCT07055867

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

An observational study of Mpox (Monkeypox), run by Osaka Metropolitan University at 1 site in Democratic Republic of the Congo.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Mpox (Monkeypox)
How many people
122 participants
Where
1 siteDemocratic Republic of the Congo
Study dates
1 Aug 2024to 31 Dec 2025
How long will I take part?
4 Weeks
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Democratic Republic of the Congo1 site

  • Equateur Provincial Public Health Laboratory

    Mbandaka, Équateur Province

Other trials in Democratic Republic of the Congo

About this study

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.
Read the detailed description

Mpox is caused by the monkeypox virus (MPXV), a member of the genus Orthopoxvirus (family Poxviridae). This virus is closely related to the variola virus, which causes smallpox. MPXV was first identified in 1958, and the first human case was reported in the Democratic Republic of the Congo (DRC) in 1970. It was presumed that the smallpox (vaccinia) vaccine would confer cross-protection against mpox. Following the global eradication of smallpox in 1980, mpox remained largely confined to limited regions in Central Africa-where zoonotic spillover from wild animal reservoirs constituted the primary route of transmission. Equateur Province is among the areas in the DRC with a notably high burden of reported mpox cases.

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.

Keywords
test negative control, case control, outbreak investigation, Mpox
Medical subject headings
Mpox, Monkeypox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07055867
Study groupRoleWhat they receive
CaseCases 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.
ControlControls 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1

  2. 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.

    Measured: Day1 and 3-4 weeks after baseline

  3. 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).

    Measured: Day1 and 3-4 weeks after baseline

  4. 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.

    Measured: Day1 and 3-4 weeks after baseline

Secondary outcomes (2)

  1. Performance of Novel Diagnostic Platforms

    To compare the performance of LAMP-based diagnostics and other emerging diagnostic methods with conventional molecular techniques like PCR.

    Outcome Metrics: Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and turnaround time.

    Measured: Day 1

  2. Clinical Recovery

    Defined by the resolution of symptoms and the absence of detectable viral load during follow-up assessments.

    Measured: 3-4 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2025
  2. Study start1 Aug 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
122 participants (estimated)
Target duration
4 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07055867
Sponsor's protocol ID
N553/BN/PMMF/2024
Status last verified
Jul 2025
First submitted
6 May 2025
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38036581

  • 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.

    PubMed 39178746

  • 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.

    PubMed 28892474

  • 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.

    PubMed 30416164

  • 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.

    PubMed 38857615

  • 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.

    PubMed 38871006

  • WHO Director-General declares mpox outbreak a public health emergency of international concern. https://www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern. 2024; published online Aug 14

  • 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.

    PubMed 36950196

  • 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.

    PubMed 4340218

  • 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.

    PubMed 35866746

Questions about this trial

What is this clinical trial studying?

An observational study of Mpox (Monkeypox), run by Osaka Metropolitan University at 1 site in Democratic Republic of the Congo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mpox positivity (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07055867, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.

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