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

Monkeypox Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05784038
• Other study ID #: NETPOX
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Hospital Israelita Albert Einstein
• Contact: Henrique AR Fonseca, PhD
• Phone: +5511968308958
• Email: henrique.fonseca[@]einstein.br
• Is FDA regulated: No
• 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 2023
• Est. primary completion date: September 2023
• 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

Related Conditions & MeSH terms

• Monkeypox

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