Back to resultsProcalcitonin Use in Pneumonia Patients in the Critical Care Setting
Primary Purpose
Pneumonia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of procalcitonin as biomarker to guide therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring procalcitonin, antimicrobial stewardship, pneumonia
Eligibility Criteria
Inclusion criteria:
- 18 years old
- admitted to critical care unit
- placed on pneumonia protocol
Exclusion criteria:
- patients who received outpatient antibiotic therapy within previous 21 days
Sites / Locations
- Mayo Clinic Health System Eau Claire
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Therapy
Procalcitonin-guided therapy
Arm Description
Procalcitonin levels will be measured to determine when it is appropriate to discontinue antibiotic therapy.
Outcomes
Primary Outcome Measures
Length of antibiotic therapy
Participants will be followed for the entire time they are on antibiotics to treat pneumonia, an expected average of 30 total antibiotic days.
Secondary Outcome Measures
Length of stay in critical care unit
Participants will be followed for their entire length of stay in the critical care unit, an expected average of 7 days.
Cost
The average cost of antibiotics per patient, measured in US dollars, based on total antibiotic days.
Length of stay in the hospital
Participants will be followed their entire length of stay in the hospital, an expected average of 14 days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01788488
Brief Title
Procalcitonin Use in Pneumonia Patients in the Critical Care Setting
Official Title
Impact of Measuring Serum Procalcitonin Levels on Duration of Antimicrobial Therapy in Critical Care Patients With Suspected Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of the study is to determine the impact of procalcitonin (PCT)-guided therapy on duration of antibiotic therapy in critical care unit (CCU) patients with suspected pneumonia at Mayo Clinic Health System Eau Claire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
procalcitonin, antimicrobial stewardship, pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Therapy
Arm Type
No Intervention
Arm Title
Procalcitonin-guided therapy
Arm Type
Experimental
Arm Description
Procalcitonin levels will be measured to determine when it is appropriate to discontinue antibiotic therapy.
Intervention Type
Other
Intervention Name(s)
Use of procalcitonin as biomarker to guide therapy
Primary Outcome Measure Information:
Title
Length of antibiotic therapy
Description
Participants will be followed for the entire time they are on antibiotics to treat pneumonia, an expected average of 30 total antibiotic days.
Time Frame
Indefinite
Secondary Outcome Measure Information:
Title
Length of stay in critical care unit
Description
Participants will be followed for their entire length of stay in the critical care unit, an expected average of 7 days.
Time Frame
Indefinite
Title
Cost
Description
The average cost of antibiotics per patient, measured in US dollars, based on total antibiotic days.
Time Frame
Once
Title
Length of stay in the hospital
Description
Participants will be followed their entire length of stay in the hospital, an expected average of 14 days.
Time Frame
Indefinite
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
18 years old
admitted to critical care unit
placed on pneumonia protocol
Exclusion criteria:
patients who received outpatient antibiotic therapy within previous 21 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Gierhart
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Health System Eau Claire
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54702
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19797133
Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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PubMed Identifier
15699079
Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Procalcitonin Use in Pneumonia Patients in the Critical Care Setting
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