Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts (NCT07267390) | Clinical Trial Compass
CompletedNot Applicable
Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts
Democratic Republic of the Congo550 participantsStarted 2025-10-31
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* MOVIE Study:
* Cases of severe Mpox requiring hospitalization.
* Individuals with a confir…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to undetectable MPXV DNA in skin lesion swabs measured by quantitative PCR
Timeframe: From day 1 to day 56
2
Time to undetectable MPXV DNA in oropharyngeal swabs measured by quantitative PCR
Timeframe: From day 1 to day 56
3
Time to undetectable MPXV DNA in blood measured by quantitative PCR
Timeframe: From day 1 to day 56
4
Secondary attack rate of mpox among contacts of index cases
Timeframe: From day 1 to day 14
Trial details
NCT IDNCT07267390
SponsorFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia