Brief description of trial (Data source: BASEC)
Blutstrominfektionen gehören zu einem häufigen Grund für Aufnahme auf die Intensivstation und komplizieren bei sonst kritisch kranken Patienten den Verlauf der Erkrankung. Eine richtige Behandlung mit Medikamenten (Antibiotika), die diesen Blutstrominfekt (Blutvergiftung) gezielt bekämpfen ist grundlegend für eine gute Erholung. Es ist jedoch unklar, wie lange eine ähnliche Behandlung dauern soll; eine zu lange antibiotische Behandlung ist wahrscheinlich unnötig und kann zudem zu einigen unerwünschten Effekten führen.
Health conditions investigated(Data source: BASEC)
Blutstrominfektion bei Patienten auf der Intensivstation.
Health conditions
(Data source: WHO)
Bacteremia;Intensive Care;Critically Ill;Sepsis;Mortality;Antimicrobial
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Mit dieser Studie wird untersucht, ob eine gezielte Behandlung mit Antibiotikum über 7 Tage bei Patienten mit Blutstrominfektionen genauso gut oder sogar besser als eine längere 14 Tage lange antibiotische Behandlung ist.
Interventions
(Data source: WHO)
Other: 7 days of adequate antibiotic treatment;Other: 14 days of adequate antibiotic treatment.
Criteria for participation in trial
(Data source: BASEC)
Patienten auf der Intensivstation, die einen im Labor bestätigten Blutstrominfekt haben.
Exclusion criteria
(Data source: BASEC)
- Patienten mit schwer eingeschränkter Immunabwehr (= immunsuprimierte Patienten)
- Patienten mit künstlichen Herzklappen oder Gefässprothesen
- Patienten mit einem Infekt, der bekanntermassen für längere Dauer behandelt werden muss (zB. Herzmuskel oder Herzklappenentzündung (Endokarditis), Knochen- oder Gelenk-Entzündung (Osteomyelitis; Arthritis))
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
1. Patient is in ICU or non-ICU ward at the time the blood culture is drawn or reported
as positive.
2. Patient has a positive blood culture with pathogenic bacteria.
Exclusion Criteria:
1. Patient already enrolled in the trial
2. Patient has severe immune system compromise, as defined by: absolute neutrophil count
<0.5x109/L; or is receiving immunosuppressive treatment for solid organ or bone marrow
or stem cell transplant
3. Patient has a prosthetic heart valve or synthetic endovascular graft (post major
vessel repair with synthetic material) (note: coronary artery stents are not an
exclusion)
4. Patient has documented or suspected syndrome with well-defined requirement for
prolonged treatment:
i) infective endocarditis; ii) osteomyelitis/septic arthritis; iii)
undrainable/undrained abscess; iv) unremovable/unremoved prosthetic-associated
infection (e.g. infected pacemaker, prosthetic joint infection, ventriculoperitoneal
shunt infection etc.) (note: central venous catheters, including tunneled central
intravenous catheter, and urinary catheters are not excluded unless the treating
clinical team does not have equipoise for enrollment and randomization to either
group)
5. Patient has a single positive blood culture with a common contaminant organism
according to Clinical Laboratory & Standards Institute (CLSI) Guidelines: coagulase
negative staphylococci; or Bacillus spp.; or Corynebacterium spp.; or
Propionobacterium spp.; or Aerococcus spp.; or Micrococcus spp.
6. Patient has a positive blood culture with Staphylococcus aureus or Staphylococcus
lugdunensis
7. Patient has a positive blood culture with Candida spp. or other fungal species.
8. Blood culture grows rare bacterial pathogens requiring prolonged treatment (e.g.
Mycobacteria spp., Nocardia spp., Actinomyces spp., Brucella spp., Burkholderia
pseudomallei)
-
Further information on trial
Date trial registered
Dec 20, 2016
Recruitment status
Completed
Academic title
(Data source: WHO)
Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: Randomized Controlled Trial
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
90 day survival
Secundary end point
(Data source: WHO)
Hospital mortality;ICU mortality;Relapse rates of bacteremia with the same organism;Antibiotic allergy and adverse events;Rates of C. difficile infection in hospital;Rates of secondary nosocomial infection/colonization with antimicrobial resistant organisms in hospital;ICU length of stay;Hospital length of stay;Mechanical ventilation duration;Antibiotic free days
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Bern
Countries
(Data source: WHO)
Australia, Canada, Israel, New Zealand, Saudi Arabia, Switzerland, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. med. Josef Prazak
+41-31-632-7572
josef.prazak@insel.ch
Contact for general information
(Data source: WHO)
Nick Daneman, MD
Sunnybrook Health Sciences Centre
Contact for scientific information
(Data source: WHO)
Nick Daneman, MD
Sunnybrook Health Sciences Centre
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Bern
Date of authorisation by the ethics committee
19.10.2020
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2020-00512
Secondary ID (Data source: WHO)
0796
Back to overview
