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Clinical Trials/NCT02417168
NCT02417168
Terminated
Not Applicable

Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients - Pilot Study

CAMC Health System1 site in 1 country1 target enrollmentJuly 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
CAMC Health System
Enrollment
1
Locations
1
Primary Endpoint
Change in procalcitonin levels
Status
Terminated
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2015
End Date
March 1, 2016
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
CAMC Health System
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in procalcitonin levels

Time Frame: 24 hours

Procalcitonin will be measured at the time of admission (Zero hours) and at 12, at 24 hours from admission.

Secondary Outcomes

  • The presence of bacteremia(1 week)

Study Sites (1)

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