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Epidemiology of Malaria in Ubon Ratchathani, Thailand

19 de enero de 2017 actualizado por: University of Oxford

Epidemiology of Malaria in Ubon Ratchathani, Thailand: a Case-control Study

This is an observational study (case-control study) aiming to identify risk factors for malaria infection in health centers or malaria posts or district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand.

This study expects to recruit 330 cases (malaria positive) and 330 control (negative cases) subject. One-to-one matching of cases (malaria positive) and controls (malaria negative) will be done at each study site.

CASE (Malaria positive) subject will go through the following;

  1. Enrollment visit (Day 0)

    1.1 Blood collection of three dried blood spots, and malaria slide. In district hospitals in individuals >14 kg: additional 10ml venous blood will be collected.

    1.2 A survey questionnaire which includes patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones will be administered.

  2. Follow up visits (if fever plus Day 42 (+/-3))

2.1 Blood collection of three dried blood spots and malaria slide. In district hospitals: additional 0.5ml venous blood will be collected.

2.2 Short survey questionnaire including questions on symptoms, travel and possible risk behaviors since enrollment will be administered.

CONTROL (Malaria negative) subject will go through the following;

  1. Enrollment visit (Day 0)

    1.1 Blood collection to confirm negative malaria slide. In district hospitals: additional 0.5ml venous blood will be collected.

    1.2 A survey questionnaire including patient demographics, information on any recent malaria treatment they may have taken, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones will be administered.

  2. Follow up visit: No follow up visit

Descripción general del estudio

Descripción detallada

Study sites and enrollment:

Patients self-presenting to (1) health centres or(2) malaria posts or (3) district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand and requiring a diagnostic test for malaria as determined by the treating clinician will be recruited. Those who are malaria positive will be candidate cases and those who are malaria negative will be candidate controls.

One-to-one matching of cases and controls will be done at each study site. One control will be matched to each case. The matching criteria will be the next malaria negative patient to attend the study site of the same gender and age+/-5 years as an enrolled malaria positive case.

Study procedure:

CASE (Malaria patient defined by positive RDT or blood smear)

Upon enrollment, the below study procedures will be followed;

  1. Blood samples consisting of:

    • Three dried blood spots
    • A microscopy slide
    • In the district hospitals only, 10 ml of venous blood will be taken from the positive for malaria patient.
  2. A survey include patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phone will be administered to each patient.

CONTROL (Non-malaria patient defined by negative RDT or blood smear)

Upon enrollment, for those negative for malaria, the below study procedures will be follows;

  1. Blood samples consisting of:

    • Blood smear
    • In the district hospitals only, 0.5 ml of venous blood will also be collected.
  2. A survey include patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phone swill be administered to each patient.

CASE: Follow-up

  • If patients develop a fever after the end of antimalarial treatment and within 42 days after enrollment, they will be asked to return for follow-up as soon as possible on one occasion and then again at 42 (+/-3) days.
  • If they do not develop fever within 42 days after enrollment, they will be asked to return for follow up at 42 (+/-3) days.

At the follow-up visit, blood will be taken to test for malaria by microscopy, three dried blood spots will be taken and a short survey administered including questions on symptoms, travel and possible risk behaviors since enrollment.

*In the district hospitals only, 1.5ml of venous blood will be taken

CONTROL: No follow up

Tipo de estudio

De observación

Inscripción (Anticipado)

660

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Ubon Rachatani
      • Ubon Ratchathani, Ubon Rachatani, Tailandia, 34230
        • Reclutamiento
        • Buntharik Hospital
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Tanong Kamsri, doctor

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

6 meses y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Patients self-presenting to health centres or malaria posts or district hospitals in Buntharik District and Nachalui District, Ubon Ratchathani Province, Thailand and requiring a diagnostic test for malaria as determined by the treating clinician will be recruited. Those who are malaria positive will be candidate cases and those who are malaria negative will be candidate controls.

Descripción

Inclusion Criteria:

- Case (Malaria patient defined by positive RDT or blood smear):

  • Patients of ≥ 6 months of age testing positive for malaria of any species as determined by a positive rapid diagnostic test (RDT) or asexual stage parasites on a smear of peripheral blood including individuals with more than one species of Plasmodium.

    • Control (Non-malaria patient defined by negative RDT or blood smear):
  • Patients > 6 months of age requiring a diagnostic test for malaria but testing negative for malaria by rapid diagnostic test (RDT) or asexual stage parasites on a smear of peripheral blood. Controls will be age and gender matched to individual cases at each study site (details below).

Exclusion Criteria:

Not willing to provide written informed consent.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Control de caso
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Case
Malaria patient defined by positive RDT or blood smear
A survey will be included patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones
Dried Blood Spot
Venous Blood collection
Slide blood smear
Control
Non-malaria patient defined by negative RDT or blood smear
A survey will be included patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones
Venous Blood collection
Slide blood smear

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Risk factors for Malaria infection
Periodo de tiempo: 2 years
Risk factors for malaria infection in Ubon Ratchathani Province, Thailand
2 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of malaria infections in Ubon Ratchathani Province
Periodo de tiempo: 2 years
Proportion of malaria infections that are imported in Ubon Ratchathani Province, Thailand
2 years
Prevalence of clinical antimalarial drug resistance
Periodo de tiempo: 2 years
Prevalence of clinical antimalarial drug resistance in cases of P. falciparum malaria in Ubon Ratchathani Province, Thailand
2 years
Human movement leading to spread of malaria and antimalarial drug resistance
Periodo de tiempo: 2 years
4. Estimates of the potential for spread of malaria and antimalarial drug resistance from Ubon Ratchathani Province, Thailand through human movement to other locations.
2 years
Measure antimalarial drug in blood prior to participate in the study
Periodo de tiempo: 2 years
List of antimalarials which patients have recently taken, if any, prior to presentation in order to estimate drug pressure on the parasite population.
2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de diciembre de 2016

Finalización primaria (Anticipado)

1 de diciembre de 2018

Finalización del estudio (Anticipado)

1 de diciembre de 2018

Fechas de registro del estudio

Enviado por primera vez

9 de diciembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

13 de diciembre de 2016

Publicado por primera vez (Estimar)

14 de diciembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

20 de enero de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

19 de enero de 2017

Última verificación

1 de enero de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • EPI1601

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

According to Mahidol-Oxford Tropical Medicine Research Unit policy

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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