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

Terminated

• Conditions: Cancer; Bacteremia

• Registration Number: NCT02417168
• Lead Sponsor: CAMC Health System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-10
• Study First Posted: 2015-04-15
• Study Start: 2015-07-01
• Primary Completion: 2016-03-01
• Study Completion: 2016-03-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
The presence of bacteremia	1 week	Blood will be cultured for bacteria

Trial Locations

Locations (1)

CAMC Health Systems; 🇺🇸 Charleston, West Virginia, United States