Serial Therapeutic and Antifungal Monitoring Protocol
Palabras clave
Abstracto
Descripción
One blood culture and one set of T2clinical specimens will be collected at specified intervals to monitor the clearance of Candida infection from the bloodstream.
Each T2 result will be compared to the companion blood culture result. The comparison will determine if the presence of antifungal therapy inhibits blood culture and leads to an incidence of blood culture false negative test results. The T2 result, which is not impacted by the presence of antifungal therapy, can show that the pathogen is still present for some additional period of time.
fechas
| Verificado por última vez: | 08/31/2015 |
| Primero enviado: | 06/11/2014 |
| Inscripción estimada enviada: | 06/11/2014 |
| Publicado por primera vez: | 06/15/2014 |
| Última actualización enviada: | 08/16/2018 |
| Última actualización publicada: | 08/19/2018 |
| Fecha de inicio real del estudio: | 08/31/2014 |
| Fecha estimada de finalización primaria: | 03/31/2017 |
| Fecha estimada de finalización del estudio: | 03/31/2017 |
Condición o enfermedad
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Candida Positive Patients Symptomatic adult patients, confirmed via blood culture with species identification to be positive for Candida |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Método de muestreo | Non-Probability Sample |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Subject or subject's authorized representative must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them. - Subject is between 18-95 years of age - Subject has a blood culture result that is positive for yeast within 36 hours of enrollment Exclusion Criteria: - Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study - All T2 Bio individual clinical research specimens contain < 3 ml of blood - Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 Bio blood specimens. |
Salir
Medidas de resultado primarias
1. Time to negative test result [14 days post enrollment]
