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The Molecular Epidemiology of Streptococcus Pyogenes Among Children in Leon, Nicaragua

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Qué se está recopilando

Colección de datos

Recopilados desde hoy en adelante - Prospectivo
Quiénes están siendo reclutados

Infecciones+4

+ Enfermedades Estomatognáticas

+ Enfermedades Otorrinolaringológicas

De 3 a 15 años
+3 Criterios de eligibilidad
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Cómo está diseñado el estudio

Observacional
Inicio del estudio: agosto de 2006
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de agosto de 2006

Fecha en la que se inscribió al primer participante.

Streptococcus pyogenes (GrAS) is a human pathogen that leads to great disease burden throughout the world. In the United States, an estimated 30 million infections occur yearly. Most of these are local infections of the skin or the throat but still lead to considerable use of health-care resources. These common, simple forms of GrAS disease may progress to or be followed by the more serious GrAS-related illnesses acute rheumatic fever, post-streptococcal glomerulonephritis, streptococcal toxic shock syndrome, sepsis, pneumonia, or other invasive illnesses. Outside the U.S., in the developing world, the burden of GrAS-related disease is presumed to be even higher, but is not completely elucidated in many of the poorer regions of the world. It is known, though, that rheumatic heart disease causes more cardiovascular morbidity in the children of the world than any other illness. Although the incidence of rheumatic fever in the U.S. has fallen to levels of approximately 0.5 per 100,000 per year, in some areas, the developing world's children still have rates over 100 per 100,000 per year. The percentage of cardiac admissions attributable to rheumatic heart disease in hospitals located in the developing world remains in the range of 30 to 50%, where it has been studied. GrAS is one of the best characterized human pathogens with regards to its microbiology, its spectrum of diseases, and its ability to lead to serious sequelae such as rheumatic fever and glomerulonephritis. Yet, efforts to control it through the use of antibiotics have been only partially successful in the United States and largely unsuccessful in the developing world. The health impact of uncomplicated streptococcal infections, such as pharyngitis, and the less common but more severe diseases, such as rheumatic heart disease, must be better studied in order to move forward with control measures. In this study, patients aged 3-15 presenting with sore throat, fever and cervical lymphadenopathy will be examined and a throat swab will be submitted to the lab for culture. All of these patients will be treated with either benzathine penicillin or, if they have a history of allergy to penicillin, oral erythromycin. The parent will be given a follow-up appointment to convey the result of the culture and to evaluate the course of the child's illness. Children presenting with sore throat only will be cultured and given a follow-up appointment to return after the result of the culture is known. Antibiotic treatment is given only if the culture is positive for group A streptococci. Within this algorithm is latitude for the physician to treat any patient based on clinical signs and symptoms and the concern that a particular child may not return for treatment if it is delayed based on the culture result. The overriding goal is the prevention of acute rheumatic fever and suppurative complications. The primary objective of this study is to characterize the GrAS isolates genotypically (emm type or sub-type). The secondary objective is to describe the epidemiology of throat isolates of GrAS among 3- to 15- year old children with pharyngitis living in Leon, Nicaragua. Primary endpoint of the study is the frequency and proportion of each emm-type among children with pharyngitis. Secondary Endpoints for the study are as follows: The proportion of children with pharyngitis from whom GrAS is isolated. The minimal incidence of GrAS pharyngitis in children based on annual cases per 100,000 children in the catchment areas. The age, gender, and ethnicity-specific minimal incidence rates of GrAS pharyngitis in children living in the catchment areas.

Título OficialThe Molecular Epidemiology of Streptococcus Pyogenes Among Children in Leon, Nicaragua
NCT00170521
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 13.000 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 3 a 15 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

InfeccionesEnfermedades EstomatognáticasEnfermedades OtorrinolaringológicasEnfermedades faríngeasFaringitisInfecciones del Tracto RespiratorioEnfermedades del Tracto Respiratorio

Criterios

Un criterio de inclusión requerido para participar
1. All children 3- to 15-years old with pharyngitis who are seen at a participating site will be invited to participate.

2 criterios de exclusión impiden participar
Subjects whose parents are unable or unwilling to provide informed consent will be excluded from the study.

Children who are 13 years or older and unable or unwilling to provide informed consent will be excluded form the study.

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

National Autonomous University of Nicaragua, Leon

León, NicaraguaAbrir National Autonomous University of Nicaragua, Leon en Google Maps
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