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Procalcitonin as a Marker of Bacterial Pneumonia

Primary Purpose

Pneumonia, Bronchitis, COPD

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
No antibiotics if se-procalcitonin is below stated limit
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • suspected lower respiratory tract infection
  • must be able to give consent

Exclusion Criteria:

  • age under 18 years
  • not able to give consent
  • admitted not primarily because of the respiratory tract infection
  • hospital acquired infections

Sites / Locations

  • Department of Infectious Diseases, Skejby Hospital
  • Departement of Medicin, Silkeborg Hospital

Outcomes

Primary Outcome Measures

Antibiotic use
Length of stay in hospital

Secondary Outcome Measures

The proportion of patients where the doctor chooses to disregard treatment guidelines

Full Information

First Posted
December 22, 2006
Last Updated
May 22, 2008
Sponsor
Aarhus University Hospital Skejby
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1. Study Identification

Unique Protocol Identification Number
NCT00415753
Brief Title
Procalcitonin as a Marker of Bacterial Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aarhus University Hospital Skejby

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish Hospital setting. To test if it is possible to reduce the use of antibiotics and the length of stay in hospital, and the willingness of the clinicians to take this new marker under advisement in their choice of treatment. The study is a randomised, controlled intervention study. All adult patients admitted to the Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract infection (e.g. CAP, acute exacerbation of COPD and bronchitis) are eligible for inclusion. Patients are randomised to have either PCT guided treatment or standard care, in which case the doctor will not learn the PCT test result. In the PCT group the antibiotic treatment will be based on serum PCT as follows: If PCT is less than 0.25 µg/L antibiotic treatment is discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT is greater than 0.5 µg/L antibiotic treatment is strongly encouraged. The treating doctor is allowed to overrule the treatment guidelines. The control group will receive antibiotics according to usual practice. The primary endpoints are antibiotic use and length of stay in hospital. Secondary endpoint is the proportion of patients where the treating doctor chooses to disregard the guidelines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Bronchitis, COPD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
No antibiotics if se-procalcitonin is below stated limit
Primary Outcome Measure Information:
Title
Antibiotic use
Title
Length of stay in hospital
Secondary Outcome Measure Information:
Title
The proportion of patients where the doctor chooses to disregard treatment guidelines

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: suspected lower respiratory tract infection must be able to give consent Exclusion Criteria: age under 18 years not able to give consent admitted not primarily because of the respiratory tract infection hospital acquired infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finn T Black, Professor
Organizational Affiliation
Aarhus Universityhospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristina B Kristoffersen
Organizational Affiliation
Aarhus University Hospital Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Infectious Diseases, Skejby Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Departement of Medicin, Silkeborg Hospital
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
14987884
Citation
Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7. doi: 10.1016/S0140-6736(04)15591-8.
Results Reference
background
PubMed Identifier
19416298
Citation
Kristoffersen KB, Sogaard OS, Wejse C, Black FT, Greve T, Tarp B, Storgaard M, Sodemann M. Antibiotic treatment interruption of suspected lower respiratory tract infections based on a single procalcitonin measurement at hospital admission--a randomized trial. Clin Microbiol Infect. 2009 May;15(5):481-7. doi: 10.1111/j.1469-0691.2009.02709.x. Epub 2009 Mar 5.
Results Reference
derived

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Procalcitonin as a Marker of Bacterial Pneumonia

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