Contact information
Type
Scientific
Primary contact
Prof Claudia Spies
ORCID ID
Contact details
Department of Anaesthesiology and Intensive Care Medicine
Augustenburger Platz 1
Berlin
13353
Germany
+49 (0)30 450 55 10 01
claudia.spies@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EA1/043/09
Study information
Scientific title
Clinical value of LightCycler® SeptiFast Test compared to conventional blood cultures for antimicrobial detection in post-operative septic patients: a prospective, randomised single-centre trial
Acronym
SeptiFast
Study hypothesis
Antimicrobial detection in septic patients with the LightCycler® SeptiFast Test leads to accelerated administration of appropriate antibiotic therapy.
Ethics approval
Ethics Committee of Charité - University Medicine Berlin, 12/03/2009, ref: EA1/043/09
Study design
Prospective randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sepsis due to abdominal infection or hospital acquired pneumonia
Intervention
Patients will be randomised in two groups. Samples for the LightCycler® SeptiFast Test will be taken in both groups parallel to conventional blood cultures. In group 1, the results of the LightCycler® SeptiFast Test will be made available for the treating physician, in group 2, results of the LightCycler® SeptiFast Test will be analysed retrospectively. Both groups will be assessed for changes in the initial empirical therapy (end of intervention), both groups will be followed up until resolution of all clinical signs of sepsis or discharge from the Intensive Care Unit (ICU) or for a maximum period of 30 days.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Frequency of changes of the initial antibiotic treatment related to diagnostic procedures and time until appropriate antibiotic treatment, assessed at the end of data collection.
Secondary outcome measures
1. Rate of patients with organisms detected by the LightCycler® SeptiFast Test compared to all patients with clinically confirmed sepsis
2. Rate of empirical treatment that was retrospectively confirmed to be appropriate
3. Number of days with antibiotic treatment
4. Decreasing severity of illness (Simplified Acute Physiology Score [SAPS], Sequential Organ Failure Assessment [SOFA], 28-item Therapeutic Intervention Score [TISS-28]) during treatment
5. Length of mechanical ventilation
6. Length of intensive care unit (ICU) stay
7. Length of hospital stay
8. Therapy costs
All assessed at the end of data collection.
Overall trial start date
01/01/2007
Overall trial end date
30/04/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Post-surgical patients with suspected intra-abdominal infection or hospital acquired pneumonia
2. Suspected or known infection that clinically indicates investigation by blood cultures
3. Inclusion within 72 hours of diagnosis
4. Presence of at least two criteria for systemic inflammatory response syndrome (SIRS):
4.1. Temperature greater than 38°C or less than 36°C
4.2. Heart rate greater than 90 beats/minute
4.3. Respiratory rate greater than 20 breaths/minute or partial pressure of carbon dioxide in arterial blood (PaCO2) less than 32 mmHg/4.3 kPa
4.4. White blood cell count (WBC) greater than 12.000/mm^3 or less than 4.000/mm^3 or 10% immature
5. Age greater than 17 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Moribund patients with expected survival less than 24 hours
2. Less than 18 years of age
3. Pregnancy
4. Known and confirmed organism responsible for infection
5. Participation in an other prospective clinical study during the passed 30 days
6. Consent of the patient or legal guardian cannot be obtained
Recruitment start date
11/08/2010
Recruitment end date
29/03/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Anaesthesiology and Intensive Care Medicine
Berlin
13353
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
Chariteplatz 1
Berlin
10117
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Charité Universitätsmedizin Berlin
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Germany
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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25911587