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

NCT ID: NCT02417168

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2016-03-01

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.

Conditions

Cancer; Bacteremia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CureSearch for Children's Cancer

UNKNOWN

Sponsor Role: collaborator

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CAMC Health Systems

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

14-42

Identifier Type: -

Identifier Source: org_study_id