Overview
Sponsor-declared trial summary
Postantibiotic diarrhoea in critically ill patients
Percentage of patients with treatment failure at day 7 after randomisation. Treatment failure is defined as either failure to administer allocated treatment for any reason or the presence of diarrhoea on day 7 after randomisation.
Key facts
- Sponsor
- Fakultni Nemocnice Kralovske Vinohrady
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Decision date (initial)
- 2024-12-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519024-25-00
- EudraCT number
- 2021-002290-25
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy
Percentage of patients with treatment failure at day 7 after randomisation. 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 objectives 1
- Composite number of adverse events such as new-onset sepsis, toxic megacolon, positive post FBT blood culture, or other SAE assessed by the physician-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 infection vs. those who do not.
Conditions and MedDRA coding
Postantibiotic diarrhoea in critically ill patients
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Signed informed consent
- Age > 18 yrs.
- In-patient in ICU or HDU (incl. burn unit) and expected to stay for >7 days
- 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 4
- 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.
- Unable to tolerate enema for any reason (e.g. surgery of the GI tract in the past year).
- Pregnant and lactating woman
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of patients with treatment failure at day 7 after randomisation.
Secondary endpoints 4
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
HUMAN FAECAL TRANSPLANT purified from allogeneic faecal donations
PRD11693458 · Product
- Active substance
- Allogeneic Faecal Microbiota, Pooled
- Substance synonyms
- MaaT 033, Allogeneic fecal microbiota, pooled, Pooled allogeneic faecal microbiota
- Pharmaceutical form
- GASTROENTERAL SUSPENSION
- Route of administration
- INTESTINAL
- Max daily dose
- 350 ml millilitre(s)
- Max total dose
- 700 ml millilitre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- FAKULTNI NEMOCNICE KRALOVSKE VINOHRADY
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fakultni Nemocnice Kralovske Vinohrady
- Sponsor organisation
- Fakultni Nemocnice Kralovske Vinohrady
- Address
- Srobarova 1150/50, Vinohrady Vinohrady
- City
- Prague
- Postcode
- 100 00
- Country
- Czechia
Scientific contact point
- Organisation
- Fakultni Nemocnice Kralovske Vinohrady
- Contact name
- Dr Frantisek Duska, PhD
Public contact point
- Organisation
- Fakultni Nemocnice Kralovske Vinohrady
- Contact name
- Dr Frantisek Duska, PhD
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D_FEBATRIC_Souhrn protokolu_verze 1-0 | 1.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements_BLANK | 1 |
| Subject information and informed consent form (for publication) | L_FEBATRIC_Informovany souhlas - darce_verze 3-1 | 3.1 |
| Subject information and informed consent form (for publication) | L_FEBATRIC_Informovany souhlas - prijemce_ zkracena verze_verze 1-1 | 1.1 |
| Subject information and informed consent form (for publication) | L_FEBATRIC_Informovany souhlas - prijemce_verze 4-2 | 4.2 |
| Summary of Product Characteristics (SmPC) (for publication) | J_FEBATRIC_Stitek FNKV | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-29 | Czechia | Acceptable 2024-11-29
|
2024-12-03 |