Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study.
INCREMENT-SOT
Other study identifiers
Sponsor study identifier
observational
820
1 country
3
Study Start
January 1, 2016
Actual (reported)Primary Completion
October 31, 2016
Actual (reported)Study Completion
January 1, 2018
Actual (reported)Brief Summary
Main objective: to observationally assess the efficacy and safety of different antimicrobials in BSI due to ESBL or carbapenemase-producing Enterobacterales in SOT. Secondary objectives:
- 1.To evaluate the efficacy and safety of different antibiotics used for the treatment of infections caused by ESBL- and carbapenemase-producing Enterobacterales in the SOT population.
- 2.To compare the efficacy of different antimicrobials between SOT and non-SOT patients (using matched controls from the "non-transplant" INCREMENT cohort).
- 3.To create a microbiological collection of ESBL- and carbapenemase-producing Enterobacterales isolated from the SOT population.
- 4.To provide data on specific MICs for each antimicrobial evaluated.
- 5.To provide data on the prevalence of specific mechanisms of resistance and their clinical impact in the particular setting of SOT.
- 6.To organise an international consortium capable of developing high quality prospective cohort studies and randomised clinical trials in the area of MDR and XDR Enterobacterales in SOT.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 820 participants
- Study completion date
January 1, 2018
Actual (reported)- Listed locations
- 1 countries · 3 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
January 1, 2016
Actual (reported)First Submitted
July 28, 2016
Actual (reported)First Posted
August 2, 2016
Actual (reported)Primary Completion
October 31, 2016
Actual (reported)Study Completion
January 1, 2018
Actual (reported)
- Last Updated
- March 28, 2019
- Status Verified
- March 2019
- Last Update Submitted
- March 26, 2019