Mpox (Monkeypox)MOVIE-TRACENCT07267390
Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts
An observational study of Mpox (Monkeypox), run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Democratic Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mpox (Monkeypox)
- How many people
- 550 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 31 Oct 2025to 27 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All individuals with confirmed Mpox infection, regardless of age or sex.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Univeristy of Kinshasa
Kinshasa
About this study
Official title: MOVIE-TRACE Study: Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts
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.
Read the detailed description
Starting in late 2023, an increasing number of confirmed cases of Mpox caused by clade I Mpox virus (MPXV) were reported across several provinces of the Democratic Republic of the Congo (DRC). In August 2024, the World Health Organization (WHO) declared the ongoing outbreak a Public Health Emergency of International Concern due to its expanding geographic spread and significant public health impact.
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
- Mpox (Monkeypox)
- Keywords
- viral clearance, secondary attack rate, DRC
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MOVIE | Mpox confirmed case | |
| TRACE | Contact of a MOVIE case |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to undetectable MPXV DNA in skin lesion swabs measured by quantitative PCR
Time from enrollment to the first skin lesion swab with undetectable MPXV DNA, defined as cycle threshold (Ct) >35 by quantitative polymerase chain reaction (qPCR).
Measured: From day 1 to day 56
Time to undetectable MPXV DNA in oropharyngeal swabs measured by quantitative PCR
Time from enrollment to the first oropharyngeal swab with undetectable MPXV DNA, defined as Ct >35 by qPCR.
Measured: From day 1 to day 56
Time to undetectable MPXV DNA in blood measured by quantitative PCR
Time from enrollment to the first blood sample with undetectable MPXV DNA, defined as Ct >35 by qPCR.
Measured: From day 1 to day 56
Secondary attack rate of mpox among contacts of index cases
Secondary attack rate (SAR), defined as the proportion of contacts of laboratory-confirmed mpox cases who develop laboratory-confirmed mpox during follow-up, assessed through clinical evaluation and MPXV qPCR testing.
Measured: From day 1 to day 14
Secondary outcomes (1)
Epidemiological, clinical, and exposure-related factors associated with mpox transmission
Transmission-related factors will be assessed using standardized epidemiological questionnaires and clinical case report forms administered to index cases and contacts at baseline and follow-up. Variables assessed will include type and frequency of contact, exposure to skin lesions or bodily fluids, sleeping arrangements, sexual contact, household characteristics, symptoms, lesion burden, and MPXV DNA results by qPCR. Associations with transmission will be evaluated by comparing characteristics of transmitting versus non-transmitting index cases and infected versus non-infected contacts.
Measured: From day 1 to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start31 Oct 2025
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mpox (Monkeypox)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kinshasa, London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Oriol Mitja, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Investigators
- Oriol Mitjà, Professor, Principal investigator, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267390
- Sponsor's protocol ID
- MOVIE-TRACE
- Acronym
- MOVIE-TRACE
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will be shared under reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOVIE-TRACE Study: Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts
- ClinicalTrials.gov ID
- NCT07267390
- Acronym / sponsor ID
- MOVIE-TRACE / MOVIE-TRACE
- Conditions
- Mpox (Monkeypox)
- Keywords
- viral clearance, secondary attack rate, DRC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- University of Kinshasa, London School of Hygiene and Tropical Medicine
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Starting in late 2023, an increasing number of confirmed cases of Mpox caused by clade I Mpox virus (MPXV) were reported across several provinces of the Democratic Republic of the Congo (DRC). In August 2024, the World Health Organization (WHO) declared the ongoing outbreak a Public Health Emergency of International Concern due to its expanding geographic spread and significant public health impact.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOVIE | – | –Mpox confirmed case |
| TRACE | – | –Contact of a MOVIE case |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals with confirmed Mpox infection, regardless of age or sex.
Key inclusion criteria (13 listed)
- MOVIE Study:
- TRACE Study:
Key exclusion criteria (8 listed)
- MOVIE Study:
- TRACE Study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to undetectable MPXV DNA in skin lesion swabs measured by quantitative PCR
Time frame: From day 1 to day 56
Time from enrollment to the first skin lesion swab with undetectable MPXV DNA, defined as cycle threshold (Ct) >35 by quantitative polymerase chain reaction (qPCR).
Time to undetectable MPXV DNA in oropharyngeal swabs measured by quantitative PCR
Time frame: From day 1 to day 56
Time from enrollment to the first oropharyngeal swab with undetectable MPXV DNA, defined as Ct >35 by qPCR.
Time to undetectable MPXV DNA in blood measured by quantitative PCR
Time frame: From day 1 to day 56
Time from enrollment to the first blood sample with undetectable MPXV DNA, defined as Ct >35 by qPCR.
Secondary attack rate of mpox among contacts of index cases
Time frame: From day 1 to day 14
Secondary attack rate (SAR), defined as the proportion of contacts of laboratory-confirmed mpox cases who develop laboratory-confirmed mpox during follow-up, assessed through clinical evaluation and MPXV qPCR testing.
1 secondary outcome
Epidemiological, clinical, and exposure-related factors associated with mpox transmission
Time frame: From day 1 to day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will be shared under reasonable request
Related trials for Mpox (Monkeypox)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oriol Mitjà, Professor principal investigator
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mpox (Monkeypox), run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to undetectable MPXV DNA in skin lesion swabs measured by quantitative PCR (time frame: From day 1 to day 56). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.