Mpox
Conditions
Interventions
Not applicable
Sponsors
Centre de Recherche et de Formation en Infectiologie de Guinee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Population of Confirmed Cases - Confirmed cases, regardless of sex or age. - Voluntary participants who have signed informed consent for adults (>18 years). - Informed consent signed by at least one of the two parents or the legal guardian authorizing the child’s participation in the study. - Assent from minors capable of providing it. - Residing in the study area and agreeing to 12-month follow-up. 2) Population of Contact Cases - Persons of any sex and age. - Meeting the definition of a contact case (i.e., sharing the same household, direct contact, sexual contact) with an index or confirmed case included in the study during the month preceding symptom onset. - Not previously diagnosed with mpox. - Voluntary agreement to participate through informed consent for adults (>18 years) or parental/legal guardian consent for minors (<18 years).
Exclusion criteria
Exclusion criteria: - Subjects unable to adhere to the study protocol or comply with procedural requirements, or for whom 9-month follow-up is impossible due to logistical or safety reasons. - Inability to provide consent or consent not given. - Not residing at the study sites in the DRC and Guinea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical status at D0, D14, and D28, assessed on an ordinal scale by a study physician or nurse: i) all lesions completely resolved and no serious complications, ii) all lesions inactive and no serious complications, iii) one or more active lesions but no serious complications, iv) serious complication and/or hospitalization due to mpox, v) death.;Change from baseline in mpox DNA levels in throat swabs, presence of mpox DNA in lesion swabs, presence of mpox DNA in urine and anal swabs, presence of mpox DNA in semen and vaginal secretions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to complete lesion resolution, defined as the duration until all lesions are fully resolved (all scabs fallen off with intact skin underneath, and healing of mucosal lesions), measured from the date of the positive sample up to 9 months post-enrollment;Proportion of serious complications, defined as a life-threatening complication, hospitalization or prolongation of an existing hospitalization, disability or handicap, or any other medically significant complication.;Case fatality rate, defined as the proportion of deaths related to mpox or to a specific condition, among the total number of cases;Proportion of mpox survivors with sequelae: dermatological (superinfection, septicemia, scarring, corneal involvement, persistent proctitis), neurological (headache, muscle pain, extreme fatigue, confusion, encephalitis), psychiatric (psychological distress, major depression);Change from baseline in anti-mpox antibody titers, percentage of seropositive subjects among contact cases, percentage of seropositive subjects among asymptomatic contacts.;Proportion of different clade types across sites | — |
Countries
Democratic Republic of the Congo, Guinea
Contacts
Public ContactManfred Accrombessi
Senior epidemiologist
Outcome results
None listed