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

NCT02417168 | Terminated

• 1 other identifier: 14-42
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The presence of bacteremia

  1 week

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CAMC Health System: lead
• CureSearch for Children's Cancer: collaborator

Study Sites (1)

CAMC Health Systems

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Neoplasms; Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 15, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

US (1)