Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections
21 de julio de 2017 actualizado por: LIjuan Zhou, People's Hospital of Zhengzhou University
A Retrospective Study of Relationships Between Loading Regimen，Serum Trough Concentrations，Efficacy and Safety in Pneumonia Patients With Gram-positive Infections Treated With Teicoplanin
This was a retrospective study that all teicoplanin-treated adult patients with Gram-positive infections admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from February 2015 to August 2016.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
- Patients and protocol This was a retrospective study that all teicoplanin-treated adult patients with Gram-positive infections admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from February 2015 to August 2016. Patients were included who met the following criteria: (1) age≥18 years, (2) duration of teicoplanin therapy≥5 days, (3) written informed consent was obtained from each patients. Patients were excluded who fulfilled any of the following criteria: (1) Patients who were allergy to teicoplanin, (2) pregnant women, (3) patients with hematopoietic function, (4) patients unable to evaluate efficacy and safety. This study was approved by the research ethics committee of the Zhengzhou Central Hospital affiliated to Zhengzhou University.
- Treatment regimen and groups According to CLcr and teicoplanin loading dose regimen, all patients were divided into four groups. Group A (CLcr≥60mL/min) : Teicoplanin was intravenously administered 3 times for moderate infections (skin, soft tissue and respiratory infections) or 6 times for severe infections(endocarditis caused by MRSA or severe pneumonia) at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d. Group B (40 mL/min≤CLcr<60mL/min) : Teicoplanin was intravenously administered 3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d. Group C (CLcr<40mL/min) : Teicoplanin was intravenously administered 2 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d. Group D (standard regimen) : Teicoplanin was intravenously administered 1-3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d. The maintenance dosing was adjusted by Cmin and CLcr in all groups. The target Cmin was set to 15~30 mg/L. If Cmin<15 mg/L or >30 mg/L, the maintenance dosage was increased or decreased appropriately up to target Cmin range. CLcr values for male and female were calculated based on the following equations, respectively.
Tipo de estudio
Tipo de estudio
De observación
Inscripción (Actual)
Inscripción
113
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
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
The clinical data of 113 patients who were suffered with severe Gram-positive infection and treated with teicoplanin from February 2015 to August 2016 were retrospectively analyzed.
Descripción
Inclusion Criteria:
- age≥18 years
- duration of teicoplanin therapy≥5 days
- written informed consent was obtained from each patients
Exclusion Criteria:
- Patients who were allergy to teicoplanin
- pregnant women
- patients with hematopoietic function
- patients unable to evaluate efficacy and safety
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
Número de grupos/cohortes
4
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Group A
Group A (CLcr≥60mL/min) : Teicoplanin was intravenously administered 3 times for moderate infections (skin, soft tissue and respiratory infections) or 6 times for severe infections(endocarditis caused by MRSA or severe pneumonia) at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d.
|
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents.
Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
|
|
Group B
Group B (40 mL/min≤CLcr<60mL/min) : Teicoplanin was intravenously administered 3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 400 mg/d.
|
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents.
Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
|
|
Group C
Group C (CLcr<40mL/min) : Teicoplanin was intravenously administered 2 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d.
|
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents.
Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
|
|
Group D
Group D (standard regimen) : Teicoplanin was intravenously administered 1-3 times at the loading dose of 400 mg at 12h intervals, followed by maintenance dosing 200 mg/d.
|
If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents.
Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Serum teicoplanin trough concentrations
Periodo de tiempo: 0.5 hour before teicoplanin administration on the fourth day
|
Teicoplanin trough samples were taken immediately 30 minutes before teicoplanin administration on the fourth day.
Blood samples for 2-3 mL were collected in blood-collection tubes without any additives and centrifuged at 3500 rpm for 10min.
Serum teicoplanin trough concentrations (Cmin) were determined by a high-performance liquid chromatography method as previously described.
The detections were completed in Translational Medicine Center of Zhengzhou Central Hospital affiliated to Zhengzhou University.
|
0.5 hour before teicoplanin administration on the fourth day
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
White blood cell count (WBC)
Periodo de tiempo: 2 years
|
It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
|
C-reaction protein (CRP)
Periodo de tiempo: 2 years
|
It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
|
Asparttate aminotransferase (AST)
Periodo de tiempo: 2 years
|
It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
|
Alanine aminotransferase (ALT)
Periodo de tiempo: 2 years
|
It is an indicator of liver function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
|
Serum creatinine (Scr)
Periodo de tiempo: 2 years
|
It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
|
CLcr
Periodo de tiempo: 2 years
|
It is an indicator of renal function.It was completed before initiation and after completion of teicoplanin therapy in Zhengzhou city clinical inspection center.
|
2 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
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)
Inicio del estudio
1 de febrero de 2015
Finalización primaria (Actual)
Finalización primaria
20 de agosto de 2016
Finalización del estudio (Actual)
Finalización del estudio
30 de octubre de 2016
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
19 de julio de 2017
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2017
Publicado por primera vez (Actual)
Publicado por primera vez
25 de julio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
25 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
21 de julio de 2017
Última verificación
Última verificación
1 de julio de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- LZhou
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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.
Sí
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. .
Ensayos clínicos sobre Pneumonia Gram-Positive Bacterial
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NCT00362245RetiradoMeningitis Gram negativa | Meningitis bacteriana postraumática
-
NCT02288234TerminadoInfecciones complicadas de la piel y la estructura de la piel | Neumonía bacteriana adquirida en el hospital | Neumonía bacteriana asociada al ventilador | Infección Gram Positiva
-
NCT01431326TerminadoInsuficiencia cardiaca | Epilepsia | Dolor | Neumonía | Septicemia | Inflamación | Hipertensión | Enfermedades Renales Crónicas | Hemofilia | Esquizofrenia