Evaluation of an Innovative Tuberculosis Diagnostic Test (PROMISE-TB)
Evaluation, of Innovative Tuberculosis Diagnostic Tests - Promoting Infant Health and Nutrition in Sub-Saharian Africa (PROMISE Consortium)
Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low sensitivity of available diagnostic tools.
This project aims at evaluating two innovative immunological methods for diagnosing of active TB among HIV-infected and uninfected children.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The study is designed as a prospective study for the evaluation of diagnostic tests.
Children admitted with probable TB based on clinical and radiological symptoms are recruited. Gastric lavage or sputum on two to three consecutive days will be collected as per routine practise. Active TB will be defined as a positive GeneXpert diagnostic test or MTB culture.
In addition, children with no sign of TB will be recruited to estimate the specificity of the diagnostic tests. These children will be recruited from the surgical ward of the hospital, and matched for age group and HIV status.
In all children, blood samples will be drawn and stored to perform quantiferon (R) and the new tests under evaluation.
The analysis will evaluate the sensitivity and specificity of the tests against the current gold standard (detection of Mycobacterium tuberculosis (MTB) in any specimen obtained from the patient). Identification of diagnosis algorithms, including these tests if they prove to be informative, will be elaborated and evaluated.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Lusaka, Zambia
- Reclutamiento
- Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM
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Contacto:
- Mwiya Miwya, MD
- Número de teléfono: +260 211 257535
- Correo electrónico: mwiya2002@yahoo.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Children aged 0 to 15 years with a definite diagnosis of tuberculosis infection, HIV-infected or uninfected.
They will be matched on age and HIV status, to an equivalent number of children without any evidence of tuberculosis infection.
Descripción
Inclusion Criteria for tuberculosis cases:
one of 4 clinical signs
- persistent and unexplained cough
- unexplained weight loss or failure to thrive
- persistent and unexplained fever
- persistent and unexplained lethargy or reduced playfulness
- chest X-Ray consistent with a tuberculosis infection
- an adenitis compatible with non-pulmonary tuberculosis Among these children only those with confirmed TB will be analysed for the primary outcome
Inclusion Criteria for controls:
- children without any of the signs and symptoms quoted above
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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HIV-infected children with confirmed TB
Hospitalized children with TB confirmed by culture or GeneXpert
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HIV-uninfected children aged<5 years with confirmed TB
Hospitalized children aged<5 years with TB confirmed by culture or GeneXpert
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HIV-uninfected children aged>4 years with confirmed TB
Hospitalized children aged>4 years with TB confirmed by culture or GeneXpert
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HIV-infected control children
Children hospitalized in the surgery ward without any evidence of tuberculosis infection
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HIV-uninfected controls aged <5 years
Children <5 years hospitalized in the surgery ward without any evidence of tuberculosis infection
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HIV-uninfected controls aged >4 years
Children >4 years hospitalized in the surgery ward without any evidence of tuberculosis infection
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Proportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition
Periodo de tiempo: baseline
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baseline
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Proportion of tuberculosis negative children who are correctly identified as such by a immunoenzymatic test for tuberculosis
Periodo de tiempo: baseline
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baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Edouard Tuaillon, MD, PhD, Université de Montpellier, France
- Director de estudio: Chipepo Kankasa, MD, PhD, University of Zambia, Zambia
- Silla de estudio: Philippe Van de Perre, MD, PhD, Université de Montpellier, France
- Investigador principal: Nicolas Nagot, MD, PhD, Université de Montpellier, France
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (Estimar)
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
Otros números de identificación del estudio
- ANRS12293 PROMISE-TB
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Ensayos clínicos sobre VIH
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Icahn School of Medicine at Mount SinaiIRRASReclutamientoHemorragia Intraventricular (HIV)Estados Unidos
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Yale UniversityTerminadoPrecocidad | Recién nacidos de muy bajo peso al nacer | Hemorragia Intraventricular (HIV) | Sangrado en el cerebroEstados Unidos
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China Medical University HospitalDesconocidoDisplasia broncopulmonar | Bebés extremadamente prematuros | TLP grave que las terapias convencionales han fallado | Sin anomalías congénitas graves | no Hiv Severa Ni FPV QuísticaTaiwán