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

NCT05784038 | Recruiting

• 1 other identifier: NETPOX
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Monkeypox; MPOX

Outcome Measures

Primary Outcomes (1)

• Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions

  symptoms' incidence in participants with mpox infection

  Up to 90 days after the inclusion

Secondary Outcomes (4)

• Death

  Up to 90 days after the inclusion

• Hospitalizations

  Days 15, 30, 60, and 90

• Untargeted metabolomics of total plasmas and skin lesion

  Days 15, 30, 60, and 90

• Viral genomic

  Day 0

Study Arms (1)

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; Diagnostic Test: Untargeted Metabolomics

Interventions

Viral genomic DIAGNOSTIC_TEST

Evaluation of mpox viral genomic

Human cases of monkeypox confirmed by PCR

Untargeted Metabolomics DIAGNOSTIC_TEST

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

Human cases of monkeypox confirmed by PCR

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who have risk factors for mpox infection in Brazil.

You may qualify if:

• 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)

You may not qualify if:

• Inability to provide informed consent;
• Patient who, judging by the study team, does not have a condition for decentralized follow-up

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Ministry of Health, Brazil: collaborator

Study Sites (3)

Hospital Universitário João de Barros Barreto

Belém, Pará, Brazil

RECRUITING

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

RECRUITING

Hospital Naval Marcílio Dias

Rio de Janeiro, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples; Urine; oropharynx and Skin Lesions

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Henrique Fonseca

  Hospital Albert Einstein

  STUDY CHAIR

Central Study Contacts

Henrique AR Fonseca, PhD

CONTACT

+5511968308958; henrique.fonseca@einstein.br

Diogo Moia, PharmD

CONTACT

diogo.moia@einstein.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 24, 2023
• Study Start: July 16, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)