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Procalcitonin Use in Pneumonia Patients in the Critical Care Setting

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ClinicalTrials.gov Identifier: NCT01788488
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : June 25, 2013
Sponsor:
Information provided by (Responsible Party):
Kent H. Gierhart, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Pneumonia Other: Use of procalcitonin as biomarker to guide therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Measuring Serum Procalcitonin Levels on Duration of Antimicrobial Therapy in Critical Care Patients With Suspected Pneumonia
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Therapy
Experimental: Procalcitonin-guided therapy
Procalcitonin levels will be measured to determine when it is appropriate to discontinue antibiotic therapy.
Other: Use of procalcitonin as biomarker to guide therapy



Primary Outcome Measures :
  1. Length of antibiotic therapy [ Time Frame: Indefinite ]
    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 :
  1. Length of stay in critical care unit [ Time Frame: Indefinite ]
    Participants will be followed for their entire length of stay in the critical care unit, an expected average of 7 days.

  2. Cost [ Time Frame: Once ]
    The average cost of antibiotics per patient, measured in US dollars, based on total antibiotic days.

  3. Length of stay in the hospital [ Time Frame: Indefinite ]
    Participants will be followed their entire length of stay in the hospital, an expected average of 14 days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788488


Locations
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United States, Wisconsin
Mayo Clinic Health System Eau Claire
Eau Claire, Wisconsin, United States, 54702
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Kent Gierhart Mayo Clinic

Publications:

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Responsible Party: Kent H. Gierhart, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01788488     History of Changes
Other Study ID Numbers: 12-008835
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013
Keywords provided by Kent H. Gierhart, Mayo Clinic:
procalcitonin
antimicrobial stewardship
pneumonia
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Anti-Infective Agents