Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts
NCT ID: NCT07267390
Last Updated: 2025-12-05
Study Results
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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RECRUITING
550 participants
OBSERVATIONAL
2025-10-31
2026-01-31
Brief Summary
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Detailed Description
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Mpox is transmitted through direct contact with skin or mucosal lesions of infected individuals, contaminated materials. MPXV can be detected in multiple biological samples, including skin lesion swabs, blood, throat swabs, and occasionally urine. However, there is still limited information on how long and in which compartments the virus can persist, as well as on how efficiently it spreads between individuals during community outbreaks caused by clade I virus.
The MOVIE-TRACE project includes two complementary observational studies designed to address these critical gaps in knowledge and to strengthen the understanding of clade I MPXV infection in the DRC.
The MOVIE study aims to describe how MPXV is cleared from the body over time among patients with PCR-confirmed Mpox infection. Despite the importance of isolation and infection control in outbreak management, there is limited evidence on how long individuals remain infectious. MOVIE addresses this critical gap by conducting longitudinal follow-up of Mpox-positive patients for up to two months, with several scheduled visits during which multiple biological specimens are collected. These samples will be analyzed to assess viral persistence in different body compartments and to characterize the kinetics of viral clearance. The findings will help refine isolation duration, improve clinical management, and guide infection prevention policies.
The TRACE study seeks to understand how Mpox spreads from confirmed cases to their contacts. By systematically collecting exposure data and testing contacts for infection, TRACE will estimate the Secondary Attack Rate (SAR) and identify factors that increase the likelihood of transmission. This information will support public health measures such as contact tracing, quarantine strategies, and targeted vaccination in endemic regions.
Together, MOVIE and TRACE will generate essential evidence on both viral clearance and transmission of clade I MPXV, providing a comprehensive understanding of the infection and informing data-driven outbreak response strategies in the Democratic Republic of the Congo.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MOVIE
Mpox confirmed case
No interventions assigned to this group
TRACE
Contact of a MOVIE case
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Individuals of any sex and age presenting with lesions clinically suggestive of Mpox, as assessed by a trained health worker.
* Symptom onset within the 10 days prior to the baseline assessment.
* Willingness and ability to comply with study procedures and attend scheduled follow-up visits for up to two months.
* Availability for follow-up throughout the study period.
* Provision of written informed consent by the participant, or consent by a legally authorized representative for minors or individuals unable to provide it themselves.
* Assent obtained from children aged 12 years or older.
* For participants who cannot read or write, witnessed consent will be obtained.
* TRACE Study:
* Individuals who have had close physical contact with a polymerase chain reaction (PCR)-confirmed Mpox case within 14 days from the onset of symptoms in the index case.
* Close physical contact is defined as being within 2 meters of an infected person-particularly in enclosed spaces-for at least 5 minutes (based on CDC's 2-meter rule for droplet transmission).
* Willingness and ability to comply with the study protocol and attend scheduled follow-up assessments.
* Provision of written informed consent by the participant, or consent by a legally authorized representative for individuals unable to provide it themselves.
Exclusion Criteria
* Cases of severe Mpox requiring hospitalization.
* Individuals with a confirmed alternative diagnosis explaining their illness.
* Prior vaccination against Mpox.
* Individuals over 40 years of age who report having received smallpox vaccination during infancy.
* TRACE Study:
* Prior vaccination against Mpox.
* Individuals over 40 years of age who report having received smallpox vaccination during infancy.
ALL
Yes
Sponsors
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University of Kinshasa
OTHER
London School of Hygiene and Tropical Medicine
OTHER
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
OTHER
Responsible Party
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Oriol Mitja
Associate Professor, Infectious Diseases and Global Health
Principal Investigators
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Oriol Mitjà, Professor
Role: PRINCIPAL_INVESTIGATOR
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Locations
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Univeristy of Kinshasa
Kinshasa, , Democratic Republic of the Congo
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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MOVIE-TRACE
Identifier Type: -
Identifier Source: org_study_id
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