- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06350851
Sviluppo di un nuovo test diagnostico rapido per supportare l'eliminazione dell'oncocercosi (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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Cameroon
-
Yaoundé, Cameroon, Camerun, 5797
- Higher Institute for Scientific and Medical Research
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: Group1: Control subjects (non-infected with filariasis)
Blood drawing + feces sample collection |
Blood and feces samples will be collected from each volunteer. |
|
Altro: Group 2: Subjects mono-infected with Onchocerca volvulus
Blood drawing + feces sample collection |
Blood and feces samples will be collected from each volunteer. |
|
Altro: Group 3: Subjects mono-infected with Loa loa
Blood drawing + feces sample collection |
Blood and feces samples will be collected from each volunteer. |
|
Altro: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluation of the performance of the prototype diagnostic test
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Philippe LEISSNER, Bioaster
- Investigatore principale: Joseph KAMGNO, ISM (Higher Institute for Scientific and Medical Research)
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Attributi della malattia
- Infezioni
- Malattie parassitarie
- Malattie della pelle
- Malattie della pelle, infettive
- Infezioni da spiruridi
- Infezioni secernentee
- Infezioni da nematodi
- Malattie della pelle, parassitarie
- Elmintiasi
- Filariosi
- Condizioni patologiche, segni e sintomi
- Malattie della pelle e del tessuto connettivo
- Oncocercosi
- Mansonelliasi
- Malattie trascurate
- Loiasi
- Infezioni da Dipetalonema
- Tecniche investigative
- Gestione dei campioni
- Tecniche di laboratorio clinico
- Tecniche e procedure diagnostiche
- Diagnosi
- Forature
- Procedure chirurgiche, operative
- Sistema digestivo fenomeni fisiologici
- Sistema digestivo e fenomeni fisiologici orali
- Defecazione
- Collezione di campioni di sangue
Altri numeri di identificazione dello studio
- BA161WP1
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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