Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Procalcitonin to guide duration of antibiotic therapy in intensive care patients: a randomised controlled single-centre trial
Acronym
Study hypothesis
Daily serum procalcitonin determination reduces length of antibiotic therapy.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Bacterial infection in intensive care patients
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Duration of antibiotic therapy.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/2006
Overall trial end date
31/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110
Total final enrolment
110
Participant 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
Recruitment start date
01/01/2006
Recruitment end date
31/03/2007
Locations
Countries of recruitment
Germany
Trial participating centre
West Coast Hospital
Heide
25746
Germany
Sponsor information
Organisation
Westküstenkliniken [West Coast Hospitals]
Sponsor details
Esmarchstr.50
Heide
25746
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Westküstenkliniken [West Coast Hospitals]
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18463831
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19493352
Publication citations
-
Results
Hochreiter M, Köhler T, Schweiger AM, Keck FS, Bein B, von Spiegel T, Schroeder S, Procalcitonin to guide duration of antibiotic therapy in intensive care patients: a randomized prospective controlled trial., Crit Care, 2009, 13, 3, R83, doi: 10.1186/cc7903.
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Hochreiter M, Köhler T, Schweiger AM, Keck FS, Bein B, von Spiegel T, Schröder S, [Antibiotic treatment of surgical intensive care patients: procalcitonin to guide duration of therapy]., Anaesthesist, 2008, 57, 6, 571-577, doi: 10.1007/s00101-008-1379-x.