Condition category
Injury, Occupational Diseases, Poisoning
Date applied
17/07/2009
Date assigned
18/09/2009
Last edited
19/02/2016
Prospective/Retrospective
Prospectively 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

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 measures

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

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

http://www.charite.de/

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25911587

Publication citations

Additional files

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.