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

NCT ID: NCT05784038

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-16

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Monkeypox MPOX

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Viral genomic

Intervention Type DIAGNOSTIC_TEST

Evaluation of mpox viral genomic

Untargeted Metabolomics

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Viral genomic

Evaluation of mpox viral genomic

Intervention Type DIAGNOSTIC_TEST

Untargeted Metabolomics

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Brazil

OTHER_GOV

Sponsor Role collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henrique Fonseca

Role: STUDY_CHAIR

Hospital Albert Einstein

Locations

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Hospital Universitário João de Barros Barreto

Belém, Pará, Brazil

Site Status RECRUITING

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Hospital Naval Marcílio Dias

Rio de Janeiro, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Henrique AR Fonseca, PhD

Role: CONTACT

+5511968308958

Diogo Moia, PharmD

Role: CONTACT

Facility Contacts

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Rita Sousa, MD-PhD

Role: primary

Lucas Theotônio, MD-PhD

Role: primary

Hemerson Luz, MD-PhD

Role: primary

Other Identifiers

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NETPOX

Identifier Type: -

Identifier Source: org_study_id

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