Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-30 @ 6:51 PM
Study NCT ID:
NCT06840860
Status:
RECRUITING
Last Update Posted:
2025-05-02
First Post:
2025-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)
Sponsor:
Institute of Tropical Medicine, Belgium
Organization:
Study Overview
Official Title:
Monkeypox Biology, Outcome, Transmission and Epidemiology (MBOTE) Study: Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MBOTE-EPIC
Brief Summary:
This study aims to better understand how mpox is spreading in the DRC, how it affects different groups of people, and how well vaccines protect against it. The study is designed as a cross-sectional survey, meaning researchers will collect and analyze data from patients diagnosed with mpox at a single point in time. It will also use a case-control approach, comparing people who test positive for the virus to those who test negative, to identify risk factors and evaluate the effectiveness of the vaccine.
Detailed Description:
This study aims to better understand how mpox is spreading in the DRC, how it affects different groups of people, and how well vaccines protect against it. The study is designed as a cross-sectional survey, meaning researchers will collect and analyze data from patients diagnosed with mpox at a single point in time. It will also use a case-control approach, comparing people who test positive for the virus to those who test negative, to identify risk factors and evaluate the effectiveness of the vaccine.
The study is being conducted by Institut National de Recherche Biomédicale (INRB) in collaboration with several international partners, including the Institute of Tropical Medicine (ITM) in Belgium, Johns Hopkins University, the University of Manitoba, Médecins Sans Frontières (MSF), and other leading research institutions. The study is funded by organizations such as the European \& Developing Countries Clinical Trials Partnership (EDCTP3) and the Belgian Federal Government.
The study will be carried out in the DRC, focusing on provinces that have been hit hardest by mpox outbreaks, including North Kivu, South Kivu, Maniema, Kinshasa, and Equateur. Participants will be recruited from hospitals and health centers that provide mpox testing and care.
What Will Happen During the Study?
* People with suspected mpox who come to a hospital or health center for testing will be invited to participate.
* Participants will answer questions about their symptoms, medical history, and possible exposure to the virus, including vaccination status.
* Biological samples (blood, throat swabs, and skin lesion swabs) will be collected and analyzed for mpox and other infections such as measles or chickenpox.
* Hospitalized patients will have additional data recorded about their recovery.
Key Study Goals
* Describe how mpox affects people in different parts of the DRC, including symptoms, risk factors, and how the virus spreads.
* Compare differences between two types of the virus (clades Ia and Ib) to understand whether one is more severe than the other.
* Assess the effectiveness of the mpox vaccine by comparing vaccination rates between infected and uninfected individuals.
* Identify risk factors for severe disease, complications, and death in mpox patients.
* Investigate co-infections (e.g., with measles or chickenpox) that might worsen the disease.
* Support mpox treatment and prevention efforts by training healthcare workers and improving real-time data sharing through an online platform.
The study is being conducted by Institut National de Recherche Biomédicale (INRB) in collaboration with several international partners, including the Institute of Tropical Medicine (ITM) in Belgium, Johns Hopkins University, the University of Manitoba, Médecins Sans Frontières (MSF), and other leading research institutions. The study is funded by organizations such as the European \& Developing Countries Clinical Trials Partnership (EDCTP3) and the Belgian Federal Government.
The study will be carried out in the DRC, focusing on provinces that have been hit hardest by mpox outbreaks, including North Kivu, South Kivu, Maniema, Kinshasa, and Equateur. Participants will be recruited from hospitals and health centers that provide mpox testing and care.
What Will Happen During the Study?
* People with suspected mpox who come to a hospital or health center for testing will be invited to participate.
* Participants will answer questions about their symptoms, medical history, and possible exposure to the virus, including vaccination status.
* Biological samples (blood, throat swabs, and skin lesion swabs) will be collected and analyzed for mpox and other infections such as measles or chickenpox.
* Hospitalized patients will have additional data recorded about their recovery.
Key Study Goals
* Describe how mpox affects people in different parts of the DRC, including symptoms, risk factors, and how the virus spreads.
* Compare differences between two types of the virus (clades Ia and Ib) to understand whether one is more severe than the other.
* Assess the effectiveness of the mpox vaccine by comparing vaccination rates between infected and uninfected individuals.
* Identify risk factors for severe disease, complications, and death in mpox patients.
* Investigate co-infections (e.g., with measles or chickenpox) that might worsen the disease.
* Support mpox treatment and prevention efforts by training healthcare workers and improving real-time data sharing through an online platform.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: