Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection
13 de febrero de 2022 actualizado por: Phramongkutklao College of Medicine and Hospital
Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection Caused by Pseudomonas Aeruginosa
Peritoneal dialysis-related infection is a complication that leads to peritoneal dialysis catheter removal or patient death.
The present study aimed to investigate peritoneal dialysis-related infection, causative pathogens resulting in topical 2% mupirocin ointments period compare with 0.1% gentamicin cream period.
Rate of catheter removal, time to first peritoneal dialysis-related infection after apply gentamicin cream.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
60
Fase
- No aplica
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.
Estudio Contacto
- Nombre: Ittaprach Yimsuk, PharmD
- Número de teléfono: 097-237-4797
- Correo electrónico: ittaprach.y@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Pamila Tasanavipas, MD
- Número de teléfono: 081-344-2383
- Correo electrónico: pa_tass@hotmail.com
Ubicaciones de estudio
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-
Bangkok
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Ratchathewi, Bangkok, Tailandia, 10400
- Reclutamiento
- Phramongkutklao Hospital
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Contacto:
- Ittaprach Yimsuk, PharmD
- Número de teléfono: 097-237-4797
- Correo electrónico: ittaprach.y@gmail.com
-
Contacto:
- Pamila Tasanavipas, MD
- Número de teléfono: 081-344-2383
- Correo electrónico: pa_tass@hotmail.com
-
Investigador principal:
- Ittaprach Yimsuk, PharmD
-
Investigador principal:
- Pamila Tasanavipas, MD
-
Investigador principal:
- Daraporn Rungprai, BCP
-
Sub-Investigador:
- Wichai Santimaleeworagun, BCP
-
Sub-Investigador:
- Kulthida Chaijumroen, B.N.S.
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-
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
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age greater than or equal to 20 years
- End stage renal disease patients on peritoneal dialysis follow up at Phramongkutklao hospital's peritoneal dialysis clinic between January 1, 2021 to March 31, 2023
- Start peritoneal dialysis or follow up at Phramongkutklao hospital's peritoneal dialysis clinic at least 90 days before recruited
- Use topical mupirocin ointment for prevention of peritoneal dialysis-related infection between January 1, 2021 to December 31, 2021
- Can be used LINE application throughout the study
Exclusion Criteria:
- Allergy to gentamicin or components
- Previous systemic antibiotics use within 90 days before recruited
- Previous peritoneal dialysis-related infection within 28 days before recruited
- Immunosuppressants used
- Prospective follow up less than 2 months
- Don't sign 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
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mupirocin and Gentamicin
2% mupirocin ointments apply at exit-site once daily after wound cleaning before recruit in the study then use 0.1% gentamicin cream apply at exit-site once daily after wound cleaning after entry to the study.
|
Apply mupirocin ointments for prevention of peritoneal dialysis-related infection between 1 January 2021 to 31 December 2021
Otros nombres:
Apply gentamicin creams for prevention of peritoneal dialysis-related infection for 1 year start after 1 January 2022
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of Exit-site infection in mupirocin compared with gentamicin group
Periodo de tiempo: All exit-site infection episodes occurred last year in mupirocin group and all exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.
|
Exit-site infection diagnosis by physician.
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group.
|
All exit-site infection episodes occurred last year in mupirocin group and all exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.
|
|
Rate of Infectious peritonitis in mupirocin compared with gentamicin group
Periodo de tiempo: All infectious peritonitis episodes occurred last year in mupirocin group and all infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.
|
Infectious peritonitis diagnosis by physicians.
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
|
All infectious peritonitis episodes occurred last year in mupirocin group and all infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin group
Periodo de tiempo: All pathogenic organisms of exit-site infection episodes occurred last year in mupirocin group and all pathogenic organisms of exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.
|
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
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All pathogenic organisms of exit-site infection episodes occurred last year in mupirocin group and all pathogenic organisms of exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.
|
|
Number and percentage Causative pathogens of Infectious peritonitis in mupirocin compared with gentamicin group
Periodo de tiempo: All pathogenic organisms of infectious peritonitis episodes occurred last year in mupirocin group and all pathogenic organisms of infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.
|
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
|
All pathogenic organisms of infectious peritonitis episodes occurred last year in mupirocin group and all pathogenic organisms of infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.
|
|
Percentage of catheter removal due to peritoneal dialysis-related infection
Periodo de tiempo: Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
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Prospective data collection from patient's medical records in gentamicin group
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Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
|
|
Time to first peritoneal dialysis-related infection after gentamicin application
Periodo de tiempo: Prospective period at least 1 year after entry to the study.
|
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group.
Peritoneal-related infection diagnosis by physicians.
Prospective data collection from patient's medical records in gentamicin group
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Prospective period at least 1 year after entry to the study.
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Drug susceptibility of causative pathogens of peritoneal dialysis-related infection
Periodo de tiempo: Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
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Drug susceptibility test by broth micro-dilution and E-test.
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
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Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Daraporn Rungprai, BCP, Faculty of Pharmacy, Silpakorn University
- Silla de estudio: Ittaprach Yimsuk, PharmD, College of Pharmacy, Rangsit university
- Director de estudio: Pamila Tasanavipas, MD, Phramongkutklao hospital and College of Medicine
- Director de estudio: Wichai Santimaleeworagun, BCP, Faculty of Pharmacy, Silpakorn University
- Investigador principal: Kulthida Chaijumroen, B.N.S., Phramongkutklao hospital and College of Medicine
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 2021
Finalización primaria (Anticipado)
31 de marzo de 2023
Finalización del estudio (Anticipado)
31 de mayo de 2023
Fechas de registro del estudio
Enviado por primera vez
4 de enero de 2022
Primero enviado que cumplió con los criterios de control de calidad
13 de febrero de 2022
Publicado por primera vez (Actual)
22 de febrero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de febrero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
13 de febrero de 2022
Última verificación
1 de febrero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PDRI-2021
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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