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Recruiting NCT05784038

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

Observational Monkeypox MPOX

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Viral genomic, Untargeted Metabolomics.
Who it may be relevant to
Registry conditions: Monkeypox, MPOX. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Observational, Prospective, Cohort Study of Mpox Infection in Brazil - NETPOX Cohort

Overview

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.

Interventions

  • Diagnostic test Viral genomic
    Evaluation of mpox viral genomic
  • Diagnostic test Untargeted Metabolomics
    Evaluation of metabolomics of the total plasma, oropharynx, and skin samples.

Primary outcome measures

  • Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions [Time frame: Up to 90 days after the inclusion]
Secondary outcome measures (4)
  • Death [Time frame: Up to 90 days after the inclusion]
  • Hospitalizations [Time frame: Days 15, 30, 60, and 90]
  • Untargeted metabolomics of total plasmas and skin lesion [Time frame: Days 15, 30, 60, and 90]
  • Viral genomic [Time frame: Day 0]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Brazil · 3 centers
  • Hospital Universitário João de Barros Barreto — Belém
  • Hospital Israelita Albert Einstein — São Paulo
  • Hospital Naval Marcílio Dias — Rio de Janeiro

Identifiers

NCT: NCT05784038 · NETPOX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗