Mpox
Conditions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria: Exclusion Criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Viral clearance in skin lesions Time to undetectable MPXV viral load (>35 Ct) in skin lesions (Number of days) [Time Frame: From day 1 to day 56] 2. Viral clearance in oropharyngeal swabs Time to undetectable MPXV viral load (>35 Ct) in oropharyngeal swabs (Number of days) [Time Frame: From day 1 to day 56] 3. Viral clearance in blood Time to undetectable MPXV viral load (>35 Ct) in blood (Number of days) [Time Frame: From day 1 to day 56] 4. Mpox transmission among cases and their contacts Estimation of Secondary Attack Rate (SAR) [Time Frame: From day 1 to day 14] | — |
Secondary
| Measure | Time frame |
|---|---|
| 5. Factors of transmission Identification of factors linked to transmission [Time Frame: From day 1 to day 14] | — |
Countries
Democratic Republic of the Congo
Contacts
Professor