Procalcitonin to guide duration of antibiotic therapy in intensive care patients

ISRCTN	ISRCTN10288268
DOI	https://doi.org/10.1186/ISRCTN10288268
Secondary identifying numbers	N/A

Submission date: 19/02/2009
Registration date: 24/02/2009
Last edited: 24/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stefan Schroeder
Scientific

West Coast Hospital
Department of Anaesthesiology and Intensive Care Medicine
Esmarchstr. 50
Heide
25746
Germany

Study information

Study design	Randomised controlled single-centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Procalcitonin to guide duration of antibiotic therapy in intensive care patients: a randomised controlled single-centre trial
Study objectives	Daily serum procalcitonin determination reduces length of antibiotic therapy.
Ethics approval(s)	Ethics Committee of Medical Faculty, Christian Albrecht University of Kiel, approved on 01/12/2005 (ref: A158/05)
Health condition(s) or problem(s) studied	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
Primary outcome measure	Duration of antibiotic therapy.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/01/2006
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	110
Total final enrolment	110
Key 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.
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	31/03/2007

Locations

Countries of recruitment

Germany

Study participating centre

West Coast Hospital

Heide
25746
Germany

Sponsor information

Westküstenkliniken [West Coast Hospitals]
Hospital/treatment centre

Esmarchstr.50
Heide
25746
Germany

Website	http://www.wkk-online.de

Funders

Funder type

Hospital/treatment centre

Westküstenkliniken [West Coast Hospitals]

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2008		Yes	No
Results article	results	01/06/2009		Yes	No

Editorial Notes

24/01/2020: The final enrolment number has been added from the 2009 reference
17/01/2020: Internal review.