Observational, Prospective, Cohort Study of Mpox Infection in Brazil (NETPOX)
Study Details
Study Description
Brief Summary
The study is a prospective cohort that evaluates the clinical and immune-metabolic variables that may be linked to the risk and severity of the infection or even hospitalization or death in patients infected with the Mpox virus in Brazil. The expectation is to include at least 80 patients over six months, with a follow-up of 90 days from inclusion, through contact via decentralized visits.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Human cases of monkeypox confirmed by PCR Laboratory-confirmed mpox infection is defined as determined by polymerase chain reaction assay (PCR), culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 5 days of inclusion. |
Diagnostic Test: Viral genomic
Evaluation of mpox viral genomic
Diagnostic Test: Untargeted Metabolomics
Evaluation of metabolomics of the total plasma, oropharynx, and skin samples.
|
Outcome Measures
Primary Outcome Measures
- Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions [Up to 90 days after the inclusion]
symptoms' incidence in participants with mpox infection
Secondary Outcome Measures
- Death [Up to 90 days after the inclusion]
Incidence of death
- Hospitalizations [Days 15, 30, 60, and 90]
Incidence of hospitalization
- Untargeted metabolomics of total plasmas and skin lesion [Days 15, 30, 60, and 90]
Changes among visits of Immune-metabolomics responses related to symptoms' incidence
- Viral genomic [Day 0]
Evaluation of the pattern of viral genome of the mpox virus circulation in Brazil
Eligibility Criteria
Criteria
Inclusion Criteria:
- Men and women aged ≥ 18 years with confirmed MPOX infection.
(laboratory-confirmed monkeypox infection is defined as determined by PCR, culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 4 days of randomization)
Exclusion Criteria:
-
Inability to provide informed consent;
-
Patient who, judging by the study team, does not have a condition for decentralized follow-up
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hospital Israelita Albert Einstein
- Ministry of Health, Brazil
Investigators
- Study Chair: Henrique Fonseca, Hospital Albert Einstein
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NETPOX