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CompletedNCT00415753Updated May 23, 2008

Procalcitonin as a Marker of Bacterial Pneumonia

An interventional study of No antibiotics if se-procalcitonin is below stated limit in Pneumonia, Bronchitis and COPD, sponsored by Aarhus University Hospital Skejby. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-05-23.

Sponsored by Aarhus University Hospital Skejby · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
223
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pneumonia
  • Bronchitis
  • COPD
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 223 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Aarhus University Hospital Skejby is the lead sponsor of 59 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • age under 18 years
  • not able to give consent
  • admitted not primarily because of the respiratory tract infection
  • hospital acquired infections
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
223 participants (actual)

Interventions

  • BehavioralNo antibiotics if se-procalcitonin is below stated limit
06

What researchers measure

Primary outcomes

  1. Antibiotic use

  2. Length of stay in hospital

Secondary outcomes

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

07

Study locations

2 sites
  • Department of Infectious Diseases, Skejby Hospital
    Aarhus N, 8200, Denmark
  • Departement of Medicin, Silkeborg Hospital
    Silkeborg, 8600, Denmark
08

References and documents

Publications

  • 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. PubMed 14987884 ↗
  • 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. PubMed 19416298 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00415753
Lead sponsor
Aarhus University Hospital Skejby
First posted
Dec 25, 2006
Start date
Jun 2006
Primary completion
Apr 2007
Completion
Aug 2007
Last update
May 23, 2008

Study contacts

Finn T Black, Professor
study chair · Aarhus Universityhospital
Kristina B Kristoffersen
principal investigator · Aarhus University Hospital Skejby

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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