Actively Recruiting
Observational, Prospective, Cohort Study of Mpox Infection in Brazil - NETPOX Cohort
Led by Hospital Israelita Albert Einstein · Updated on 2024-07-17
80
Participants Needed
3
Research Sites
99 weeks
Total Duration
On this page
Sponsors
H
Hospital Israelita Albert Einstein
Lead Sponsor
M
Ministry of Health, Brazil
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate clinical and immune-metabolic factors that may influence the risk, severity, and outcomes such as hospitalization or death in patients infected with the Mpox virus in Brazil. The study focuses on people diagnosed with monkeypox and observes how their condition progresses over time. Participants are people with laboratory-confirmed Mpox infection, identified by tests like PCR, culture, or antigen tests on samples from blood, throat, anal, or skin lesions taken within five days of joining the study. The study is observational, meaning it collects data without assigning treatments, and follows patients for 90 days after inclusion through decentralized visits. During the study, researchers will monitor symptoms such as rash, fever, pain, chills, weakness, hospitalizations, and neurological effects. They will also perform laboratory tests including viral genomic analysis and metabolomics on blood and skin samples at various times. Follow-up occurs at days 15, 30, 60, and 90, with monitoring for death and hospitalizations, helping to understand the course of Mpox infection over this period.
CONDITIONS
Brief Title
Observational, Prospective, Cohort Study of Mpox Infection in Brazil (NETPOX)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older with confirmed monkeypox infection
- Laboratory confirmation by PCR, culture, or antigen test from blood, oropharynx, anal, or skin lesion sample collected within 4 days of enrollment
You will not qualify if you...
- Unable to provide informed consent
- Judged by the study team as unable to participate in decentralized follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 5 days before inclusion
Participants are screened for eligibility to participate in the trial.
Duration - Day 0
Participants undergo diagnostic tests including viral genomic evaluation and metabolomics assessments to confirm mpox infection.
1 visit (in-person)
Duration - Up to 90 days after inclusion
Participants are monitored for symptoms and outcomes such as rash, fever, hospitalization, and neurological effects.
Visits on Days 15, 30, 60, and 90
Trial Site Locations
Total: 3 locations
1
Hospital Universitário João de Barros Barreto
Belém, Pará, Brazil
Actively Recruiting
2
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Actively Recruiting
3
Hospital Naval Marcílio Dias
Rio de Janeiro, Brazil
Actively Recruiting
Research Team
H
Henrique AR Fonseca, PhD
D
Diogo Moia, PharmD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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