- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT06350851
Desenvolvimento de um novo teste de diagnóstico rápido para apoiar a eliminação da oncocercose (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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Cameroon
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Yaoundé, Cameroon, Camarões, 5797
- Higher Institute for Scientific and Medical Research
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Group1: Control subjects (non-infected with filariasis)
Blood drawing + feces sample collection |
Blood and feces samples will be collected from each volunteer. |
|
Outro: Group 2: Subjects mono-infected with Onchocerca volvulus
Blood drawing + feces sample collection |
Blood and feces samples will be collected from each volunteer. |
|
Outro: Group 3: Subjects mono-infected with Loa loa
Blood drawing + feces sample collection |
Blood and feces samples will be collected from each volunteer. |
|
Outro: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Evaluation of the performance of the prototype diagnostic test
Prazo: 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
- Diretor de estudo: Philippe LEISSNER, Bioaster
- Investigador principal: Joseph KAMGNO, ISM (Higher Institute for Scientific and Medical Research)
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Atributos da doença
- Infecções
- Doenças Parasitárias
- Doenças de pele
- Doenças de Pele Infecciosas
- Infecções por Spirurida
- Infecções por Secernentea
- Infecções por nematóides
- Doenças de Pele, Parasitárias
- Helmintíase
- Filariose
- Condições Patológicas, Sinais e Sintomas
- Doenças da Pele e do Tecido Conjuntivo
- Oncocercose
- Mansonelíase
- Doenças Negligenciadas
- Loíase
- Infecções por Dipetalonema
- Técnicas de investigação
- Manipulação de amostras
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Perfurações
- Procedimentos cirúrgicos, operatórios
- Fenômenos fisiológicos do sistema digestivo
- Sistema digestivo e fenômenos fisiológicos orais
- Defecação
- Coleção de amostras de sangue
Outros números de identificação do estudo
- BA161WP1
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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