Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Monkeypox (Mpox). Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Democratic Republic of the Congo
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Monkeypox Biology, Outcome, Transmission and Epidemiology (MBOTE) Study: Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Clinical Manifestations of Mpox [Срок оценки: 2 years]
- Sociodemographic Characteristics of Confirmed Mpox Cases [Срок оценки: 2 years]
- Exposure Factors Among Mpox Cases [Срок оценки: 2 years]
- Modes of Transmission of Mpox [Срок оценки: 2 years]
Вторичные конечные точки (11)
- Proportion of Mpox Cases Among Individuals with and without Prior Orthopoxvirus Vaccination [Срок оценки: 2 years]
- Regional Variability in Clinical Manifestations of Mpox [Срок оценки: 2 years]
- Regional Variability in Sociodemographic Characteristics of Mpox Cases [Срок оценки: 2 years]
- Regional Variability in Exposure Factors for Mpox [Срок оценки: 2 years]
- Regional Variability in Modes of Mpox Transmission [Срок оценки: 2 years]
- Differences in Clinical Symptoms Between Mpox Clades Ia and Ib [Срок оценки: 2 years]
- Comparison of Disease Severity Between Mpox Clades Ia and Ib [Срок оценки: 2 years]
- Comparison of Mpox Transmission Routes Between Clade Ia and Clade Ib Cases [Срок оценки: 2 years]
- Risk Factors for Severe Mpox Outcomes, Including Hospitalization and Mortality [Срок оценки: 2 years]
- Proportion of Mpox Cases with Co-infections Detected by PCR [Срок оценки: 2 years]
- Estimating the Risk of Complications and Mortality in Mpox Cases [Срок оценки: 2 years]
Критерии участия
Критерии включения
- Apply to be tested for VMPX at HGR or another test center.
- Patients of all ages and sexes. However, minors under the age of 12 are excluded from questions on sex life.
- The patient or his/her culturally acceptable representative is willing and able to give informed consent for participation in the study.
Критерии исключения
- NA
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Democratic Republic of the Congo · 2 центра
- Masina Mpox Treatment Center — Kinshasa
- Masina Mpox Treatment Center — Kinshasa
Публикации
- Brosius I, Vakaniaki EH, Mukari G, Munganga P, Tshomba JC, De Vos E, Bangwen E, Mujula Y, Tsoumanis A, Van Dijck C, Alengo A, Mutimbwa-Mambo L, Kumbana FM, Munga JB, Mambo DM, Zangilwa JW, Kitwanda SB, Houben S, Hoff NA, Makangara-Cigolo JC, Kinganda-Lusamaki E, Peeters M, Rimoin AW, Kindrachuk J, Low N, Katoto PDMC, Malembaka EB, Amuasi JH, Tshiani-Mbaya O, Kambaji DM, Kojan R, Kacita C, Mukadi-B PMID 39892407
Идентификаторы
NCT: NCT06840860 · 1835/24