- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06350851
Desarrollo de una nueva prueba de diagnóstico rápido para apoyar la eliminación de la oncocercosis (Obi1)
Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission.
To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected.
At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Onchocerciasis, also known as river blindness, stands as the second leading cause of infectious blindness worldwide. According to estimates by the World Health Organization (WHO), approximately 25 million people are infected globally, with another 90 million at risk. Over 99% of these cases occur in Africa, and vision loss affects around 1.15 million individuals. The primary strategy for combating onchocerciasis currently is Community Directed Treatment with Ivermectin (CDTI), requiring a minimum of 80% therapeutic coverage for 10 -15 years.
Areas of West and Central Africa endemic for loiasis and mansonellasis, where ivermectin may trigger severe side effects, pose a significant challenge in the battle against onchocerciasis. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. This situation underscores the importance of improving the specificity of onchocerciasis diagnosis to reduce cross-reactivity and false results due to other parasitic helminths in co-endemic regions. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission.
To this end, a series of cross-sectional studies will be carried out to build up a bank of well-characterized biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. These studies will take place in the Centre, Littoral, West and South regions of Cameroon over a one year period. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected. The study will begin with a screening phase during which potential participants will be diagnosed for the different filariasis. Following this screening phase, individuals meeting the inclusion criteria will be selected. Once consent has been obtained, blood samples will be taken for test development and validation of the onchocerciasis RDT. In fact, venous blood sample (in a tube containing EDTA) will be taken for each participant, by venipuncture. After collection, the tube(s) containing the blood will be stored in a cooler containing ice and transported to the laboratory within 6 hours of collection. Once at the laboratory, the plasma will be immediately prepared, then aliquoted and stored at -80ºC until transfer to BIOASTER for development and evaluation of the new diagnostic test for onchocerciasis.
At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Cameroon
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Yaoundé, Cameroon, Camerún, 5797
- Higher Institute for Scientific and Medical Research
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subjects informed of the objectives of the study and who signed a consent form
- Subjects without filariasis (for control subjects), or
- Subjects mono-infected with Onchocerca volvulus, or
- Subjects mono-infected with Loa loa, or
- Subjects mono-infected with Mansonella perstans or alternatively co-infected with Mansonella perstans and Loa loa
Exclusion Criteria:
- Pregnant or breast-feeding women
- Subjects having taken antihelminthic treatment less than 6 months before the inclusion date
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Group1: Control subjects (non-infected with filariasis)
Blood drawing + feces sample collection |
Blood and feces samples will be collected from each volunteer. |
|
Otro: Group 2: Subjects mono-infected with Onchocerca volvulus
Blood drawing + feces sample collection |
Blood and feces samples will be collected from each volunteer. |
|
Otro: Group 3: Subjects mono-infected with Loa loa
Blood drawing + feces sample collection |
Blood and feces samples will be collected from each volunteer. |
|
Otro: Group 4: Subjects mono-infected with Mansonella perstans (alternatively co-infected with Loa loa)
Blood drawing + feces sample collection |
Blood and feces samples will be collected from each volunteer. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluation of the performance of the prototype diagnostic test
Periodo de tiempo: Up to 52 weeks
|
The prototype will be evaluated with all plasma samples in order to determine the dynamic range of the test and the associated variability, as well as its performance in terms of sensitivity and specificity in relation to non-infected samples, and the absence of cross-reactivity with samples infected by Loa loa and Mansonella perstans. |
Up to 52 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Philippe LEISSNER, Bioaster
- Investigador principal: Joseph KAMGNO, ISM (Higher Institute for Scientific and Medical Research)
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Atributos de la enfermedad
- Infecciones
- Enfermedades parasitarias
- Enfermedades de la piel
- Enfermedades De La Piel Infecciosas
- Infecciones por espirurida
- Infecciones Secernentea
- Infecciones por nematodos
- Enfermedades De La Piel Parasitarias
- Helmintiasis
- Filariasis
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Oncocercosis
- Mansoneliasis
- Enfermedades Olvidadas
- Loasis
- Infecciones por Dipetalonema
- Técnicas de investigación
- Manejo de muestras
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Puntas
- Procedimientos quirúrgicos, operativo
- Sistema digestivo Fenómenos fisiológicos
- Sistema digestivo y fenómenos fisiológicos orales
- Defecación
- Recolección de muestras de sangre
Otros números de identificación del estudio
- BA161WP1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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