Condition category
Infections and Infestations
Date applied
19/02/2009
Date assigned
24/02/2009
Last edited
02/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stefan Schroeder

ORCID ID

Contact details

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

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 measures

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

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

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

West Coast Hospital (Germany)

Sponsor details

Esmarchstr.50
Heide
25746
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.wkk-online.de

Funders

Funder type

Hospital/treatment centre

Funder name

West Coast Hospital (Germany)

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes