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.

Context

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.

Objective

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.

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.

NCT06652646

Partners

• Institut National de Recherche Biomédicale (INRB)
• Institut de Médecine Tropicale (ITM)
• National Institute of Allergy and Infectious Diseases (NIAID)
• Ministère de la Santé Publique, Hygiène et Prévention (MSHP)
• Programme National de Lutte contre la Mpox et les fièvres virales Hémorragiques (PNLMPX)

Mpox isolation zone and lab

Supported by the MBOTE consortium