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SNCTP000004087 | NCT03005145 | BASEC2020-00512

Die Tatsächliche Länge der Antibiotischen Behandlung bei Blutstrominfektionen
BALANCE
Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness

Data source: BASEC (Imported from 29.11.2021), WHO (Imported from 18.04.2021)
Changed: 25.11.2021
Disease category: Infections and Infestations

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)

Antimicrobial
Bacteremia
Critically Ill
Intensive Care
Mortality
Sepsis

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: 14 days of adequate antibiotic treatment.
Other: 7 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)


Inclusion Criteria:

1. Patient is in ICU or under the care of ICU physician 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

Minimum age: 18 Years
Maximum age: N/A
Sex: All

Further information on the trial in WHO primary registry

http://www.who.int/trialsearch/Trial2.aspx?TrialID=NCT03005145

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03005145

Further information on trial

Date trial registered

20.12.2016

Incorporation of the first participant

24.02.2017

Recruitment status

Recruiting

Global completion date of trial

30.11.-0001

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)

Antibiotic allergy and adverse events
Antibiotic free days
Hospital length of stay
Hospital mortality
ICU length of stay
ICU mortality
Mechanical ventilation duration
Rates of C. difficile infection in hospital
Rates of secondary nosocomial infection/colonization with antimicrobial resistant organisms in hospital
Relapse rates of bacteremia with the same organism

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)

Switzerland might not appear as site of trial if it has not yet been entered as such in the WHO primary registry.
Australia, Canada, Israel, New Zealand, Saudi Arabia, 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
4164806100
nick.daneman@sunnybrook.ca

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

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