Postantibiotic diarrhoea in critically ill patients
Conditions
Brief summary
Percentage of patients with treatment failure at day 7 after randomisation.
Detailed description
Composite number of adverse events such as new-onset sepsis, toxic mega-colon, positive post FBT blood culture, or other SAE assessed by the physi-cian-in-charge as possibly related to FBT., SOFA score at days 4 and 7., Percentage of patients that are recurrence-free at time of hospital discharge or day 28, whichever occur earlier., Subgroup analysis will be performed for patients who are C. dif. positive vs. negative and those who will receive antibiotics for a new extraabdominal in-fection vs. those who do not.
Interventions
DRUGHUMAN FAECAL TRANSPLANT purified from allogeneic faecal donations
Sponsors
Fakultni Nemocnice Kralovske Vinohrady
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with treatment failure at day 7 after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite number of adverse events such as new-onset sepsis, toxic mega-colon, positive post FBT blood culture, or other SAE assessed by the physi-cian-in-charge as possibly related to FBT., SOFA score at days 4 and 7., Percentage of patients that are recurrence-free at time of hospital discharge or day 28, whichever occur earlier., Subgroup analysis will be performed for patients who are C. dif. positive vs. negative and those who will receive antibiotics for a new extraabdominal in-fection vs. those who do not. | — |
Countries
Czechia
Outcome results
None listed