Mpox Biology, Outcome, Transmission and Epidemiology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The MBOTE-Kamituga clinical and virological characterization protocol is a prospective observational cohort study with clinical and virological description of suspected mpox cases and longitudinal follow-up of confirmed mpox cases. Research activities will be aligned as far as possible with the response to the epidemic.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06840860

Monkeypox (Mpox)

RECRUITING

Ocular Complications of Mpox in the Democratic Republic Congo

NCT06579885

Monkeypox Mpox (Monkeypox)

RECRUITING

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

NCT07055867

Mpox (Monkeypox)

ENROLLING_BY_INVITATION

DiagRaMIE Mpox Virus-RDC for the Diagnostic of Monkeypox

NCT06840197

Mpox (Monkeypox) Monkeypox Virus Infection

NOT_YET_RECRUITING

Mpox Prospective Observational Cohort Study

NCT06291259

Monkeypox

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

For several decades, the Democratic Republic of Congo (DRC) has been the country most affected by monkeypox. While the global monkeypox epidemic (commonly known as mpox) of 2022-2023 was caused by clade II monkeypox virus (VMPX), outbreaks in the DRC are caused by the more virulent clade I variant. In recent years, and particularly in 2023, the country has seen a sharp increase in the number of cases, as well as a geographical expansion of the disease, with previously unaffected regions now reporting cases. Until recently, VMPX infections in the DRC were thought to be primarily the result of zoonotic transmission, with rather limited secondary human-to-human transmission. However, in recent months, an increasing number of cases linked to sexual transmission of clade I have been reported.

The Kamituga health zone is a densely populated mining region in South Kivu. The region reported no cases of smallpox in recent decades until, in October 2023, the disease was detected for the first time and began to affect mainly adolescents and young adults. To date, nearly 200 cases have been reported to health authorities, although the actual number of cases may be much higher due to significant under-reporting. Preliminary data show that the epidemic is mainly due to heterosexual transmission, and that up to 30% of cases are reported by sex workers, many of whom come from Burundi, Rwanda, Uganda and Tanzania. The ongoing transmission poses a significant risk of cross-border spread and could therefore lead to a new global smallpox epidemic, this time caused by the more virulent clade I.

The study will be carried out in collaboration with the Direction Provincial de la Santé/Kamituga and the Programme National de Lutte contre le Monkeypox et les Fièvres Virales Hémorragiques (PNLMPX/FVH) in the Kamituga Health Zone. Participants will be recruited at the Kamituga general referral hospital (HGR) or at health centers that provide mpox screening and treatment.

The MBOTE (Monkeypox Biology, Outcome, Transmission and Epidemiology) project is a multidisciplinary research collaboration between the National Institute for Biomedical Research (INRB), the Antwerp Institute of Tropical Medicine (ITM Antwerp) and the University of Antwerp.

This research protocol aims to better understand the mpox epidemic currently raging in the Kamituga SZ, as well as to provide more general information on the disease. The protocol describes the research activities that will be integrated into the ongoing epidemic investigation and control activities. Research activities will be aligned as far as possible with the ongoing epidemic response and should not hinder the response, but rather support it.

Similarly, sample collection will be aligned with the sampling carried out by the national program, and some samples will undergo additional analysis to answer the research objectives and questions.

Participation in this epidemic investigation protocol will in no way prevent patients from taking part in any other research study.

The study will be aligned as far as possible with the investigation and management of the epidemic by the national program. The study will therefore run for up to 2 months after the end of the epidemic (for convalescent patients who can be followed up for up to 2 months (day 59) after confirmation of infection), or could run for 2 years whether or not the epidemic is over. The shorter duration will be chosen, so as not to delay the reporting of results to the competent authorities, which will be essential for informing control and research activities in subsequent epidemics.

There is no fixed sample size defined for this protocol. On the contrary, as far as possible, all patients with suspected mpox will be included in the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mpox (Monkeypox)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* To be tested for VMPX at the HGR or another testing center. Patients of all ages and sexes
* Minors (≤ 17 years) are excluded from genital, anal and semen sampling and follow-up blood sampling.

Patient or culturally acceptable representative is willing and able to give informed consent for study participation.