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
Secondary identifying numbers EA1/043/09
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

Study designProspective randomised controlled single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleClinical 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 acronymSeptiFast
Study objectivesAntimicrobial 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) studiedSepsis due to abdominal infection or hospital acquired pneumonia
InterventionPatients 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 typeOther
Primary outcome measureFrequency 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 measures1. 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 study start date01/01/2007
Completion date30/04/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteria1. 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 criteria1. 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 enrolment11/08/2010
Date of final enrolment29/03/2012

Locations

Countries of recruitment

  • Germany

Study participating centre

Department of Anaesthesiology and Intensive Care Medicine
Berlin
13353
Germany

Sponsor information

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre

Chariteplatz 1
Berlin
10117
Germany

Website http://www.charite.de/
ROR logo "ROR" https://ror.org/001w7jn25

Funders

Funder type

Hospital/treatment centre

Charité Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)
Alternative name(s)
Medical School - Charité - University Medicine Berlin
Location
Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

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.