Feasibility of the Vapor Nanobubble Technology for Malaria Diagnostics (MalariaSense) (MalariaSense)
Feasibility of the Vapor Nanobubble Technology (MalariSense) for Malaria Diagnostics
Descripción general del estudio
Descripción detallada
This is a proof of concept study that will evaluate the feasibility of a vapor nanobubble technology (MalariSense) for malaria diagnostics. The primary objective is to determine the sensitivity of MalariSense against microscopy in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia. The secondary objectives include the following;
- To determine the sensitivity of MalariSense against PCR in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia
- To determine the specificity of MalariSense in diagnosing malaria in malaria suspected cases attending a health facility in The Gambia.
- To identify factors influencing the diagnostic accuracy of MalariSense
- To validate the protocol for a blood vessel identification for the test and assess the safety of the prototype The study site will be Basse in the Eastern region of The Gambia. The study will be conducted during the malaria transmission season (August to December 2015). Participants will be patients with suspected uncomplicated malaria presenting to the outpatient department of Basse Health centre. At baseline, suspected malaria cases (clinical assessment) will be asked to provide informed consent and then transferred to the MRC Basse field station where a finger prick blood sample will be collected for a malaria rapid diagnostic test (RDT), microscopy and on filter paper for subsequent molecular studies. In addition, they will be tested using the Malarisense Technology. Measurements will be taken from the wrist, ear lobe and finger tips. The laboratory prototype of the device will include three major components: pulsed laser with the fiber output, integrated handheld probe with the fiber launch in the center and an ultrasound sensor with pre-amplifier, and the signal acquisition hardware with software.
The study will enrol a total sample size of 50 patients with confirmed malaria. It is estimated that about 125 to 167 suspected cases will need to be screened/tested to get this sample size. The Sample size will be increased by 10% to allow for any missing values - therefore up to 185 suspected cases screened. In addition, a convenience sample of 30 malaria negative participants will be enrolled for comparisons between malaria positive and malaria negative populations. RDT positive patients will be provided with antimalarial treatment while the others will receive treatment according to their condition. Microscopy and species-specific PCR will be performed later. Microscopy results will be taken as the gold standard.
There will not be any active follow up. Study participants will be asked to come back 2 days after the test, or earlier if they notice a problem.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Basse, Upper River Region, Gambia
- Basse Health Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients presenting to the health facility with suspected uncomplicated malaria
- Provision of informed consent
Exclusion Criteria:
- Neonates and under 12 months old
- Pregnant women
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: MalariaSense device
This study will involve the evaluation of a medical diagnostic device.
All participants enrolled in the study will be assessed for malaria using MalariSense Technology and will aslo get rapid diagnostic tests (RDTs), microscopy, PCR
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All participants enrolled in the study will be assessed for malaria using the intervention device called MalariaSense technology
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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"Hemozoin-generated vapour nanobubble (H-VNB) amplitude thresholds among malaria infected and uninfected individuals"
Periodo de tiempo: Day 1
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Day 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Safety profile of Malarisense technology for malaria diagnosis
Periodo de tiempo: Day 1 - Day 3
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Safety of the MalariSense Technology for malaria diagnosis over 3 days of observation
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Day 1 - Day 3
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Correlation of incidence rate ratio of hemozoin-positive traces with level of parasite density as determined by microscopy
Periodo de tiempo: Day1 - Day 3
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Day1 - Day 3
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Umberto D'alessandro, PhD, MD, Medical Research Council Unit, The Gambia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SCC 1430
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