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Procalcitonin to guide duration of antibiotic therapy in intensive care patients
DOI 10.1186/ISRCTN10288268
ClinicalTrials.gov identifier
EudraCT number
Public title Procalcitonin to guide duration of antibiotic therapy in intensive care patients
Scientific title Procalcitonin to guide duration of antibiotic therapy in intensive care patients: a randomised controlled single-centre trial
Acronym N/A
Serial number at source N/A
Study hypothesis Daily serum procalcitonin determination reduces length of antibiotic therapy.
Lay summary
Ethics approval Ethics Committee of Medical Faculty, Christian Albrecht University of Kiel, approved on 01/12/2005 (ref: A158/05)
Study design Randomised controlled single-centre trial
Countries of recruitment Germany
Disease/condition/study domain Bacterial infection in intensive care patients
Participants - inclusion criteria All patients (both males and females, >18 years) requiring antibiotic therapy based on confirmed or highly suspected bacterial infections and at least 2 concomitant Systemic Inflammatory Response Syndrome (SIRS) criteria.
Participants - exclusion criteria 1. Patients who refused study consent
2. Patients whose antibiotic treatment had been initiated before intensive care admission
3. Patients who had therapy limitations
Anticipated start date 01/01/2006
Anticipated end date 31/03/2007
Status of trial Completed
Patient information material
Target number of participants 110
Interventions Patients were randomly assigned to either a Procalcitonin (PCT)-guided (study group) or a standard (control group) antibiotic regimen. For both groups antibiotics were selected upon confirmed or highly suspected bacterial infections.

Antibiotic therapy in the PCT-guided group was discontinued if clinical signs and symptoms of infection improved and 1) PCT decreased to <1 ng/ml or 2) the PCT value was >1 ng/ml, but had dropped to 25-35% of the initial value over 3 days.

In the control group antibiotic treatment was applied as standard regimen over 8 days.

Irrespective of the study group and at any time point, the physician in charge had the option to proceed with or adjust the antibiotic treatment, if there were clinical reasons to do so.
Primary outcome measure(s) Duration of antibiotic therapy.
Secondary outcome measure(s) No secondary outcome measures
Sources of funding West Coast Hospital (Germany)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18463831
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19493352
Contact name Dr  Stefan  Schroeder
  Address West Coast Hospital
Department of Anaesthesiology and Intensive Care Medicine
Esmarchstr. 50
  City/town Heide
  Zip/Postcode 25746
  Country Germany
Sponsor West Coast Hospital (Germany)
  Address Esmarchstr.50
  City/town Heide
  Zip/Postcode 25746
  Country Germany
  Sponsor website: http://www.wkk-online.de
Date applied 19/02/2009
Last edited 02/11/2009
Date ISRCTN assigned 24/02/2009
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