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Recruiting

NCT Number: NCT05784038

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitário João de Barros Barreto, Belém, Pará, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Viral genomic

Diagnostic Test

Evaluation of mpox viral genomic

Untargeted Metabolomics

Diagnostic Test

Evaluation of metabolomics of the total plasma, oropharynx, and skin samples.

Primary outcomes

  1. 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

    symptoms' incidence in participants with mpox infection

Secondary outcomes

  1. Death

    Time frame: Up to 90 days after the inclusion

    Incidence of death

  2. Hospitalizations

    Time frame: Days 15, 30, 60, and 90

    Incidence of hospitalization

  3. Untargeted metabolomics of total plasmas and skin lesion

    Time frame: Days 15, 30, 60, and 90

    Changes among visits of Immune-metabolomics responses related to symptoms' incidence

  4. Viral genomic

    Time frame: Day 0

    Evaluation of the pattern of viral genome of the mpox virus circulation in Brazil

Study contacts

Contact information is provided by the study sponsor or research team.

Diogo Moia, PharmD

CONTACT

[email protected]

Henrique AR Fonseca, PhD

CONTACT

[email protected]

+5511968308958

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 24, 2023
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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