Monkeypox, Biology, Outcome, Transmission and Epidemiology -Prospective Follow-up of High-risk Contacts

NCT ID: NCT06136117

Last Updated: 2025-05-07

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

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Recruitment Status

COMPLETED

Total Enrollment

257 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-22

Study Completion Date

2024-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Mpox

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Leidos Biomedical Research, Inc.

INDUSTRY

Sponsor Role collaborator

Alliance for International Medical Action

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurens Liesenborghs, Prof.

Role: PRINCIPAL_INVESTIGATOR

Institute of Tropical Medicine

Locations

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Tunda

Tunda, Maniema Province, Democratic Republic of the Congo

Site Status

Countries

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Democratic Republic of the Congo

Other Identifiers

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1657/22

Identifier Type: -

Identifier Source: org_study_id

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