Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia
-
- STATUS
- Recruiting
-
- participants needed
- 380
-
- sponsor
- Thomas Benfield
Summary
GNB5 is an investigator-initiated multicentre non-inferiority randomized controlled trial
which aims to assess the efficacy and safety of shortened
Five days after initiation of
The primary outcome is 90-day survival without clinical or microbiological failure to treatment, which will be tested with a non inferiority margin of 10%.
Description
Introduction: Prolonged use of
Methods and analysis: Investigator initiated multicenter, non-blinded, non-inferiority
randomized controlled trial with two parallel treatment arms. One arm will receive shortened
Primary endpoint is 90-day survival without clinical or microbiological failure to treatment.
Secondary endpoints include all-cause mortality, total duration of
Ethics and dissemination: Approval by Ethics Committee and National Competent Authorities will be obtained before initiation of the trial. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.
Impact: Demonstration of non-inferiority will provide needed evidence to safely shorten
Details
Condition |
|
---|---|
Age | 18years - 100years |
Treatment |
Shortened |
Clinical Study Identifier | NCT04291768 |
Sponsor | Thomas Benfield |
Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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