Monkeypox, Biology, Outcome, Transmission and Epidemiology -Prospective Follow-up of High-risk Contacts (MBOTE-CONTACT)

Institute of Tropical Medicine, Belgium

Status: Completed

Conditions: Mpox

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT06136117

1657/22

Details and patient eligibility

About

With the MBOTE-CONTACT study, a detailed follow-up study of high-risk contacts of mpox patients will be done. The MBOTE-CONTACT study will be nested in the NIH-Funded PALM-007 clinical trial (NCT05559099) and the MBOTE project on mpox transmission. The study will take place in Maniema Province, Democratic Republic of Congo (DRC). Participants will be recruited among high-risk contacts of mpox patients included in the PALM-007 trial. Consenting contacts will be either followed daily at the central study site or visited weekly by an outreach team in the community. They will be examined daily for signs and symptoms and asked to provide daily saliva and weekly blood samples for polymerase chain reaction (PCR) and/or serology. If participants develop mpox, they are offered treatment and enrollment in the PALM-007 trial.

Enrollment: 257 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ▪ Be a high-risk contact of a laboratory-confirmed mpox case, with high-risk defined as having at least one the following types of exposure:

• living in the same household as an mpox patient

• having had sexual contact or intercourse with an mpox patient

• sleeping in the same room as an mpox patient

• sharing a meal with an mpox patient

• children: having played together

  • Last exposure to the mpox index case of less than 14 days ago
  • Patients of any age and gender (children aged < 10 years are excluded from venous blood sampling)
  • Patient or culturally acceptable representative is willing and able to give informed consent for participation in the study

Exclusion criteria

• Having previously been diagnosed with mpox in the last 3 months
• Inability or unwillingness to comply with the proposed follow-up schedule