- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02701439
SMF to Improve Performance of Microscopy for the Diagnosis of PTB in a High HIV Prevalence Setting (PTB)
Small Membrane Filtration (SMF) Method to Improve the Performance of Smear Microscopy for the Diagnosis of Pulmonary Tuberculosis in a High HIV Prevalence Setting
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
TB is a disease caused by a bacterium called Mycobacterium tuberculosis that can affect the lungs or other parts of the body. In most of the world and in Mbarara, Uganda, the method of diagnosis that is used is AFB smear microscopy. This method is widely available, inexpensive and rapid. However, this method's ability to truly detect people having TB is poor. That is, if someone has TB, the test results may say that they are negative, leading to delays in diagnosis, disease progression, and an ongoing transmission of the bacteria.
The new test for TB diagnosis we are studying is called the Small Membrane Filtration (SMF) method. This test that is being compared to the method currently being used and is very similar to the one that is currently used (standard smear microscopy) but has the advantage of concentrating the sputum (mucus) so that we can more easily see if bacteria are present in the sputum. It is hoped that a better way of knowing if someone has TB will help doctors decide when people need to be treated for TB and when not, which will improve the health of patients and help avoid passing the infection to others.
This study will enroll 740 HIV-infected and 310 HIV-uninfected adults with culture confirmed pulmonary TB. These individuals will be identified prospectively at two TB clinics in Mbarara, Uganda.
Study hypothesis: The investigators will assume that one sputum sample will be equivalent to two (null hypothesis) with respect to sensitivity unless we have evidence that the use of two has higher sensitivity (alternative hypothesis). The investigators will assume that SMF is equivalent to AFB smear with respect to sensitivity and specificity unless the investigators find evidence it is superior. The investigators will assume that SMF is equivalent to Xpert unless the investigators find evidence that Xpert is superior.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Mbarara, Uganda, 1956
- Epicentre Mbarara Research Base
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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
Descripción
Inclusion Criteria:
- Adult (≥18 years)
- Pulmonary TB suspect defined as any person who presents with a productive cough for more than 2 weeks AND accompanied by at least one other respiratory symptom (shortness of breath, chest pains, hemoptysis) and/or constitutional symptom (loss of appetite, weight loss, fever, night sweats, and fatigue) (6).
- Willing to undergo TB evaluation and spontaneously expectorate ≥2 mL of sputum
- Willing to be tested for HIV, if no results available within past 6 months
Exclusion Criteria:
- Too ill or unable to provide written consent
- Treated with TB drugs for more than 3 days
- Extra-pulmonary or disseminated TB without pulmonary involvement (i.e. no cough)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Perspectivas temporales: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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HIV-infected
Enrollment of 740 HIV-infected adults with suspicion of pulmonary TB. Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation:
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Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation:
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HIV negative
Enrollment of 350 HIV negative adults with suspicion of pulmonary TB. Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation:
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Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Sensitivity and specificity of SMF method and Xpert MTB/RIF assay
Periodo de tiempo: 24 months
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The primary endpoints of this laboratory-based study will be to determine the sensitivity and specificity of the SMF method and Xpert MTB/RIF assay, using manual MGIT liquid culture as the gold standard
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24 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yap Boum II, PhD, Epicentre
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 (Estimar)
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
- SMF-01
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.
producto fabricado y exportado desde los EE. UU.
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