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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05784038
Recruitment Status : Not yet recruiting
First Posted : March 24, 2023
Last Update Posted : March 24, 2023
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein

Study Description
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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.

Condition or disease Intervention/treatment
Monkeypox MPOX Diagnostic Test: Viral genomic Diagnostic Test: Untargeted Metabolomics

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Months
Official Title: Observational, Prospective, Cohort Study of Mpox Infection in Brazil - NETPOX Cohort
Estimated Study Start Date : April 1, 2023
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Evaluation of mpox viral genomic

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


Outcome Measures
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Primary Outcome Measures :
  1. Composed of incidence of rash, fever, adenopathy, general pain, chills, weakness, occurrence of hospitalization, and neurological repercussions [ Time Frame: Up to 90 days after the inclusion ]
    symptoms' incidence in participants with mpox infection


Secondary Outcome Measures :
  1. Death [ Time Frame: Up to 90 days after the inclusion ]
    Incidence of death

  2. Hospitalizations [ Time Frame: Days 15, 30, 60, and 90 ]
    Incidence of hospitalization

  3. Untargeted metabolomics of total plasmas and skin lesion [ Time Frame: Days 15, 30, 60, and 90 ]
    Changes among visits of Immune-metabolomics responses related to symptoms' incidence

  4. Viral genomic [ Time Frame: Day 0 ]
    Evaluation of the pattern of viral genome of the mpox virus circulation in Brazil


Biospecimen Retention:   Samples With DNA
Blood samples; Urine; oropharynx and Skin Lesions

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals who have risk factors for mpox infection in Brazil.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05784038


Contacts
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Contact: Henrique AR Fonseca, PhD +5511968308958 henrique.fonseca@einstein.br
Contact: Diogo Moia, PharmD diogo.moia@einstein.br

Sponsors and Collaborators
Hospital Israelita Albert Einstein
Ministry of Health, Brazil
Investigators
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Study Chair: Henrique Fonseca Hospital Albert Einstein
More Information
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Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT05784038    
Other Study ID Numbers: NETPOX
First Posted: March 24, 2023    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mpox (monkeypox)
Infections
Poxviridae Infections
DNA Virus Infections
Virus Diseases