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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cancer; Bacteremia

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Health Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children between the ages of birth to seventeen years who have an existing oncologic diagnosis and who present with fever to Charleston Area Medical Center Women and Children's Hospital

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in procalcitonin levels	Procalcitonin will be measured at the time of admission (Zero hours) and at 12, at 24 hours from admission.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The presence of bacteremia	Blood will be cultured for bacteria	1 week

Collaborators and Investigators

• Sponsor: CAMC Health System
• Collaborators: CureSearch for Children's Cancer

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 10, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: 14-42