Clinical value of LightCycler® SeptiFast Test compared to conventional blood cultures for antimicrobial detection in post-surgical septic patients

ISRCTN	ISRCTN70694559
DOI	https://doi.org/10.1186/ISRCTN70694559
Protocol serial number	EA1/043/09
Sponsor	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Funder	Charité Universitätsmedizin Berlin

Submission date: 17/07/2009
Registration date: 18/09/2009
Last edited: 19/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Claudia Spies
Scientific

Department of Anaesthesiology and Intensive Care Medicine
Augustenburger Platz 1
Berlin
13353
Germany

Phone	+49 (0)30 450 55 10 01
Email	claudia.spies@charite.de

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	SeptiFast
Study objectives	Antimicrobial detection in septic patients with the LightCycler® SeptiFast Test leads to accelerated administration of appropriate antibiotic therapy.
Ethics approval(s)	Ethics Committee of Charité - University Medicine Berlin, 12/03/2009, ref: EA1/043/09
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/04/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	11/08/2010
Date of final enrolment	29/03/2012

Locations

Countries of recruitment

Germany

Study participating centre

Department of Anaesthesiology and Intensive Care Medicine

Berlin
13353
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/06/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

On 04/06/2015 the following changes were made to the trial record:
1. The overall trial end date was changed from 01/09/2009 to 01/01/2007.
2. The overall trial end date was changed from 01/09/2010 to 30/04/2012.