Procalcitonin Test for Differentiation of the Cause of Pneumonia

September 24, 2020 updated by: Hee Seok Lee, National Cancer Center, Korea

Usefulness of Procalcitonin Test to Differentiate the Cause of Pneumonia in Patients With Cancers

The purpose of this study is to evaluate the usefulness of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Serum procalcitonin test is currently used as the biomarker for bacterial infection. Especially, procalcitonin test has been reported to be helpful in differentiating bacterial pneumonia from viral pneumonia, acute exacerbations of interstitial pneumonitis or chronic obstructive lung disease. However, it is not known whether procalcitonin test can help distinguish bacterial pneumonia from non-bacterial pneumonia such as radiation pneumonitis or chemotherapy-induced pneumonitis in patients with cancer.

The aim of this prospective cohort study is to observe the clinical benefits of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer.

Study Type

Observational

Enrollment (Actual)

649

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Respiratory Clinic, National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. Patients who are suspected of acute pneumonia due to symptoms and imaging findings compatible with pneumonia can be enrolled in this cohort.

    • suspected symptom: cough, sputum, dyspnea or fever/chill
    • suspected image findings: consolidation or ground-glass opacity on chest radiograph or CT

  2. All patients enrolled in this cohort undergo procalcitonin test in addition to basic microbiological test.

    • basic microbiological test: blood culture, sputum gram stain/culture, pneumococcal urinary antigen, legionella urinary antigen, mycoplasma antibody etc.

Description

Inclusion Criteria:

  • Age greater than 18 years
  • Patients who have symptoms and suspected imaging findings compatible with pneumonia

Exclusion Criteria:

  • Patients who have been treated with antibiotics or steroid therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
procalcitonin pneumonia cohort
Patients who are suspected of acute pneumonia due to symptoms and imaging findings compatible with pneumonia can be enrolled in this cohort.
Diagnostic test: procalcitonin test
All patients enrolled in this cohort undergo procalcitonin test in addition to basic microbiological test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procalcitonin level according to the cause of pneumonia in patients with cancer
Time Frame: procalcitonin level is checked within 24hours after visiting hospital
bacterial pneumonia vs. radiation pneumonitis vs chemotherapy-induced pneumonitis
procalcitonin level is checked within 24hours after visiting hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of neutropenia on procalcitonin level in patients with baterial pneumonia
Time Frame: procalcitonin level is checked within 24hours after visiting hospital
bacterial pneumonia with neutropenia vs. without neutropenia
procalcitonin level is checked within 24hours after visiting hospital
procalcitonin level in patients with atypical pneumonia
Time Frame: procalcitonin level is checked within 24hours after visiting hospital
viral pneumonia vs tuberculosis vs fungal infection
procalcitonin level is checked within 24hours after visiting hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: HEE SEOK LEE, M.D., National Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2014-0018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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