Clinical value of LightCycler® SeptiFast Test compared to conventional blood cultures for antimicrobial detection in post-surgical septic patients
ISRCTN | ISRCTN70694559 |
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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
Scientific
Department of Anaesthesiology and Intensive Care Medicine
Augustenburger Platz 1
Berlin
13353
Germany
Phone | +49 (0)30 450 55 10 01 |
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claudia.spies@charite.de |
Study information
Study design | Prospective randomised controlled single-centre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/01/2007 |
Completion date | 30/04/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
13353
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Chariteplatz 1
Berlin
10117
Germany
Website | http://www.charite.de/ |
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https://ror.org/001w7jn25 |
Funders
Funder type
Hospital/treatment centre
Charité Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)
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 | |
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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 | 01/06/2015 | 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.