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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05784038
Other study ID # NETPOX
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2024
Est. completion date December 2026

Study information

Verified date June 2024
Source Hospital Israelita Albert Einstein
Contact Henrique AR Fonseca, PhD
Phone +5511968308958
Email henrique.fonseca@einstein.br
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Hospital Israelita Albert Einstein Ministry of Health, Brazil

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Death Incidence of death Up to 90 days after the inclusion
Secondary Hospitalizations Incidence of hospitalization Days 15, 30, 60, and 90
Secondary Untargeted metabolomics of total plasmas and skin lesion Changes among visits of Immune-metabolomics responses related to symptoms' incidence Days 15, 30, 60, and 90
Secondary Viral genomic Evaluation of the pattern of viral genome of the mpox virus circulation in Brazil Day 0
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