Procalcitonin as a Marker of Bacterial Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia Bronchitis COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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No antibiotics if se-procalcitonin is below stated limit

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Skejby Hospital

Principal Investigators

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Finn T Black, Professor

Role: STUDY_CHAIR

Aarhus Universityhospital

Kristina B Kristoffersen

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital Skejby

Locations

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Department of Infectious Diseases, Skejby Hospital

Aarhus N, , Denmark

Site Status

Departement of Medicin, Silkeborg Hospital

Silkeborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND

PMID: 14987884 (View on PubMed)

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.

Reference Type DERIVED

PMID: 19416298 (View on PubMed)

Other Identifiers

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271-05-0765

Identifier Type: -

Identifier Source: org_study_id