MOVIE-TRACE Study: Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The MOVIE-TRACE project includes two complementary observational studies designed to improve the understanding of Mpox virus infection and its transmission within affected communities. The MOVIE study aims to describe the dynamics of viral clearance in patients with confirmed Mpox. It measures how the viral load changes over time in different biological samples to inform decisions about patient management and isolation guidelines. The TRACE study focuses on understanding how mpox spreads from confirmed cases to their contacts. It will estimate the Secondary Attack Rate (SAR) and identify factors associated with transmission risk. The results will help guide public health strategies for contact tracing, vaccination, and outbreak control.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• MOVIE Study:

‣ 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.

Locations
Other Locations
Democratic Republic of the Congo
Univeristy of Kinshasa
RECRUITING
Kinshasa
Contact Information
Primary
Sara Buezo, Doctor
sbuezo@lluita.org
+34934657897
Time Frame
Start Date: 2025-10-31
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 550
Treatments
MOVIE
Mpox confirmed case
TRACE
Contact of a MOVIE case
Related Therapeutic Areas
Sponsors
Leads: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborators: London School of Hygiene and Tropical Medicine, University of Kinshasa

This content was sourced from clinicaltrials.gov