RecruitingNCT07267390

Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts

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

Sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Enrollment

550 participants

Start Date

Oct 31, 2025

Study Type

OBSERVATIONAL

Conditions

Mpox (Monkeypox)

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

Inclusion Criteria13

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.

Exclusion Criteria8

MOVIE Study:
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.