Procalcitonin Test for Differentiation of the Cause of Pneumonia

• Sponsor: National Cancer Center, Korea (Other)
• Overall Status: Completed
• CT.gov ID: NCT03350802
• Collaborator: (none)
• Enrollment: 649
• Location: 1
• Actual Duration (Months): 77.9
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Procalcitonin; Pneumonia; Cancer	Diagnostic Test: procalcitonin test

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 Design

• Study Type: Observational
• Actual Enrollment: 649 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Usefulness of Procalcitonin Test to Differentiate the Cause of Pneumonia in Patients With Cancers
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Procalcitonin level according to the cause of pneumonia in patients with cancer [procalcitonin level is checked within 24hours after visiting hospital]

   bacterial pneumonia vs. radiation pneumonitis vs chemotherapy-induced pneumonitis

Secondary Outcome Measures

1. Influence of neutropenia on procalcitonin level in patients with baterial pneumonia [procalcitonin level is checked within 24hours after visiting hospital]

   bacterial pneumonia with neutropenia vs. without neutropenia

2. procalcitonin level in patients with atypical pneumonia [procalcitonin level is checked within 24hours after visiting hospital]

   viral pneumonia vs tuberculosis vs fungal infection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Respiratory Clinic, National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	410-769

Sponsors and Collaborators

• National Cancer Center, Korea

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hee Seok Lee, Pulmonologist, National Cancer Center, Korea
• ClinicalTrials.gov Identifier: NCT03350802
• Other Study ID Numbers: NCC2014-0018
• First Posted: Nov 22, 2017
• Last Update Posted: Sep 25, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia

Study Results

No Results Posted as of Sep 25, 2020