Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients-Pilot Study
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EstadoTerminado
Patrocinadores
CAMC Health System
Colaboradores
CureSearch for Children's Cancer
ENSAYO CLÍNICO: NCT02417168
BioSeek: nct02417168
Palabras clave
Abstracto
Fevers raise the concern for serious bacterial infections in pediatric oncology patients receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there can be a false negative result.
Thus, the biomarker, procalcitonin, has been investigated for its predictive ability to identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology patients. A reliable predictor of bacteremia infections in pediatric oncology patients should decrease hospitalizations for fever and unnecessary antibiotic treatment.
In our study we will measure procalcitonin levels in pediatric oncology patients presenting with fever. We will measure procalcitonin at the time of admission which is part of our standard of care for febrile pediatric oncology admissions. For the purpose of our study, we will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission. We will examine procalcitonin levels at these three timepoints to determine if elevated procalcitonin levels predict bacteremia in pediatric oncology patients with and without neutropenia.
fechas
| Verificado por última vez: | 02/29/2020 |
| Primero enviado: | 04/09/2015 |
| Inscripción estimada enviada: | 04/09/2015 |
| Publicado por primera vez: | 04/14/2015 |
| Última actualización enviada: | 03/01/2020 |
| Última actualización publicada: | 03/03/2020 |
| Fecha de inicio real del estudio: | 06/30/2015 |
| Fecha estimada de finalización primaria: | 02/29/2016 |
| Fecha estimada de finalización del estudio: | 02/29/2016 |
Condición o enfermedad
Cancer
Bacteremia
Fase
-
Criterio de elegibilidad
| Sexos elegibles para estudiar | All |
| Método de muestreo | Non-Probability Sample |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Children between the ages of birth to seventeen years. - Present to Charleston Area Medical Center Women and Children's Hospital - Existing pediatric oncology diagnosis. - Temperature greater than 38.0 C or 100.5 Fahrenheit. - Central venous access or functional port available. Exclusion Criteria: - Any non-pediatric (eighteen years and above) oncology patient or a non-oncology patient. - The patient does not have central venous access or a port from which the blood can be drawn. |
Salir
Medidas de resultado primarias
1. Change in procalcitonin levels [24 hours]
Procalcitonin will be measured at the time of admission (Zero hours) and at 12, at 24 hours from admission.
Medidas de resultado secundarias
1. The presence of bacteremia [1 week]
Blood will be cultured for bacteria
