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    Summary
    EudraCT Number:2021-002290-25
    Sponsor's Protocol Code Number:FEBATRIC
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2021-002290-25
    A.3Full title of the trial
    Faecal bacteriotherapy for postantibiotic diarrhoea in critically ill patients
    Fekální bakterioterapie při léčbě postantibiotického průjmu u kriticky nemocných pacientů
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Transmission of bacteria from healthy donor stool to the patients gut as first-line treatment of postantibiotic diarrhoea in the critically ill patients
    Přenos bakterií ze stolice zdravých dárců do střeva kriticky nemocných pacientů jako terapie první volby u postantibiotického průjmu
    A.4.1Sponsor's protocol code numberFEBATRIC
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNadační fond Donatio intensivistam
    B.1.3.4CountryCzechia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name Faecal bacteriotherapy solution
    D.2.1.2Country which granted the Marketing AuthorisationCzechia
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFaecal bacteriotherapy solution
    D.3.4Pharmaceutical form Enema
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    Rectal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postantibiotic diarrhoea
    Průjem po antibiotické léčbě
    E.1.1.1Medical condition in easily understood language
    Postantibiotic diarrhoea in critically ill patients is common, often protracted and currently there is no effective treatment or it.
    Postantibiotický průjem u kriticky nemocných pacientů je často dlouhodobá a obtížně léčitelná komplikace terapie antibiotiky
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    Počet pacientů u kterých dojde k selháním léčby v den 7 po randomizaci. Selhání léčby je definováno buď jako nepodání FBT z jakéhokoli důvodu, nebo přítomnost průjmu v den 7 po randomizaci.
    E.2.2Secondary objectives of the trial
    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.
    Výskyt nežádoucích událostí jako je nově vzniklá sepse, toxické megakolon, pozitivní hemokutivace po FBT nebo jiná SAE, hodnocená odpovědným lékařem jako pravděpodobně souvisejí s FBT.
    Skóre SOFA ve dnech 4 a 7.
    Počet pacientů bez recidivy v době propuštění z nemocnice nebo 28. den hospitalizace.
    Bude provedena analýza podskupin pacientů, kteří jsou C. dif. pozitivní vs. negativní. Dále pa u pacientů, kteří dostanou antibiotika pro nově diagnostikovanou extraabdominální infekci vs. ti, kteří ATB léčbu léčbu nedostanou.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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.
    Podepsaný informovaný souhlas se studií
    Věk> 18 let
    Pacient na JIP (vč. popáleninové jednotky) a předpokládaná hospitalizace po dobu> 7 dnů
    Průjem po antibiotické léčbě definovaný jako 3 nebo více stolic denně nebo stolice typu Bristol 7 v objemu> 300 ml / den přetrvávající po dobu 24 hodin, přestože byla zastavena enterální výživa .
    E.4Principal exclusion criteria
    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). 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
    Bezprostředně hrozící úmrtí pacienta
    Nově přítomnost sepse, která je definovaná podle definice z roku 2016
    Laktát> 2,0 mM, průměr tlustého střeva> 9 cm na prostém RTG
    Nutnost pokračující antibiotické léčby z jiných důvodů.
    Nemožnost provedení klystýru z jakéhokoli důvodu (např. chirurgický zákrok na GI traktu v minulém roce či jiné důvody).
    Anamnéza těžké anafylaktické potravinové alergie
    Jakýkoliv jiný důvodu, který podle úsudku ošetřujícího lékaře činí transplantaci stolice nebezpečnou nebo neproveditelnou
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with treatment failure at day 7 after randomisation.
    Procento pacientů u kterých dojde k selhání léčby v den 7 po randomizaci.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As long as the patient remains on ICU, adverse events, antibiotic treatment, and stool volume/frequency are monitored daily. Treatment failure is defined as either failure to administer allocated treatment for any reason or the presence of diarrhoea on day 7 after randomisation.
    Dokud bude pacient hospitalizovaný na JIP, jsou denně sledovány nežádoucí účinky, léčba antibiotiky a objem / frekvence stolice. Selhání léčby je definováno buď jako nepodání léčby z jakéhokoli důvodu, nebo přítomnost průjmu v den 7 po randomizaci.
    E.5.2Secondary end point(s)
    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.
    Výskyt nežádoucích událostí jako je nově vzniklá sepse, toxické megakolon, pozitivní hemokutivace po FBT nebo jiná SAE, hodnocená odpovědným lékařem jako pravděpodobně souvisejí s FBT.
    Skóre SOFA ve dnech 4 a 7.
    Počet pacientů bez recidivy v době propuštění z nemocnice nebo 28. den hospitalizace.
    Bude provedena analýza podskupin pacientů, kteří jsou C. dif. pozitivní vs. negativní. Dále pa u pacientů, kteří dostanou antibiotika pro nově diagnostikovanou extraabdominální infekci vs. ti, kteří ATB léčbu léčbu nedostanou.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As long as the patient remains on ICU, adverse events, antibiotic treatment, and stool volume/frequency are monitored daily. In patients with faecal management device in place, follow up visits (identical to Day 4) are performed in 7 days interval up to day 28, and/or ICU discharge or FMD removal, whichever occurs earlier. In patients who are not on ICU, but remain at hospital, will be visited by a research nurse at day 7, 14, 21 and 28 as long as they remain hospitalised. The visit will include monitoring of adverse event, notice on patient general status, the presence/absence of diarrhoea, antibiotic medication. Blood will be collected and frozen.
    Six month follow up is performed at follow up clinics.
    Dokud pacient zůstane na JIP, jsou denně sledovány nežádoucí účinky, léčba antibiotiky a objem / frekvence stolice. Pacienti, kteří nebudou hospitalizováni na JIP, ale budou stále hospitalizováni v nemocnici, budou 7., 14., 21. a 28. den navštíveni studijní sestrou. Součástí návštěvy bude sledování nežádoucích účinků, zhodnocení celkového stavu pacienta, přítomnost / nepřítomnost průjmu, antibiotická léčba. Bude v pravidelných intervalech odebrána krev, která bude zmrazena pro další analýzu. S odstupem 6 ti měsíců budou pacienti kontaktováni studijní sestrou
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    last visit last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Critically ill patients who may or may not have capacity to give informed consent (coma, sedated..etc.)
    Kriticky nemocní pacienti, kteří nemůžou vyjádřit souhlas se studiií (např. sedování pacienti na UPV, pacienti v komatu aj.)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will not be followed up for any evaluation after the end of the study.
    Pacienti po ukončení studie nebudou dále sledováni pro účel jakékoli hodnocení.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
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