Observational, Prospective, Cohort Study of Mpox Infection in Brazil (NETPOX)

Recruiting

• Conditions: Monkeypox; MPOX
• Interventions: Diagnostic Test: Viral genomic; Diagnostic Test: Untargeted Metabolomics

• Registration Number: NCT05784038
• Lead Sponsor: Hospital Israelita Albert Einstein

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-24
• Status Verified: 2024-06
• Study Start: 2024-07-16
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-01
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Human cases of monkeypox confirmed by PCR	Untargeted Metabolomics	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.
Human cases of monkeypox confirmed by PCR	Viral genomic	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Death	Up to 90 days after the inclusion	Incidence of death

Trial Locations

Locations (3)

Hospital Naval Marcílio Dias; 🇧🇷 Rio De Janeiro, Brazil

Hospital Universitário João de Barros Barreto; 🇧🇷 Belem, Para, Brazil

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Sao Paulo, Brazil