ALLOGENEIC FAECAL MICROBIOTA, POOLED for Postantibiotic diarrhoea

Inclusion criteria

• {"criterion_text":"- Signed informed consent\n- Age > 18 yrs.\n- In-patient in ICU or HDU (incl. burn unit) and expected to stay for >7 days\n- Diarrhoea following antibiotic treatment defined as 3 or more stools per day or Bristol type 7 stool in the volume >300 ml/day if stool derivative device is in place, persisting for 24 hours despite enteral feeding formula has been stopped"}

Exclusion criteria

• {"criterion_text":"- Death appears imminent or ceilings of care put in place, presence of new-onset sepsis defined as per 2016 definition, lactate >2.0 mM, colon diameter > 9 cm on plain AXR, the necessity of ongoing antibiotic treatment for another reasons.\n- Unable to tolerate enema for any reason (e.g. surgery of the GI tract in the past year).\n- Pregnant and lactating woman\n- Patients with a history of severe anaphylactic food allergy, any other reason which – as per judgement of the treating clinician – makes faecal transplantation unsafe or not feasible"}

Primary endpoints

• {"endpoint_text":"- Percentage of patients with treatment failure at day 7 after randomisation.","definition_or_measurement_approach":"Treatment failure is defined as either failure to administer allocated treatment for any reason or the presence of diarrhoea on day 7 after randomisation."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite count of specified adverse events assessed by the physician-in-charge as possibly related to faecal bacteriotherapy (FBT)."}
• {"endpoint_text":"- SOFA score at days 4 and 7.","definition_or_measurement_approach":"Sequential Organ Failure Assessment (SOFA) score measured on day 4 and day 7 after randomisation."}
• {"endpoint_text":"- Percentage of patients that are recurrence-free at time of hospital discharge or day 28, whichever occur earlier.","definition_or_measurement_approach":"Proportion of patients without recurrence of diarrhoea at hospital discharge or by day 28, whichever is earlier."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Planned subgroup analyses comparing outcomes for C. difficile positive versus negative patients and for patients who receive antibiotics for a new extra-abdominal infection versus those who do not."}

Czechia

Earliest CTIS Part Ii Submission Date

15-10-2024

Latest Decision Or Authorization Date

03-12-2024

Processing Time Days

49

Number Of Sites

1

Number Of Participants

36

Primary sponsor

Full Name

Fakultni Nemocnice Kralovske Vinohrady

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia