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    The EU Clinical Trials Register currently displays   44306   clinical trials with a EudraCT protocol, of which   7355   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2019-002677-57
    Sponsor's Protocol Code Number:PREVAN
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-002677-57
    A.3Full title of the trial
    A phase III, multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of oral vancomycin versus placebo in preventing relapse of Clostridioides difficile infection in patients receiving systemic antibiotic therapy (PREVAN-ICD study).
    Ensayo clínico multicéntrico, fase III, aleatorizado, doble ciego para evaluar la eficacia y seguridad de vancomicina oral versus placebo en la prevención de la recidiva de la infección por Clostridioides difficile en pacientes que reciben antibioterapia sistémica (Estudio PREVAN-ICD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter study to evaluate the effect and safety of oral vancomycin compared with placebo in the prevention of relapse due to Clostridium difficile infection in patients treated with antibiotics administered systemically.
    Estudio multicéntrico para evaluar el efecto y la seguridad de la vancomicina oral en comparación con placebo en la prevención de recaidas por infección por Clostridium difficile en pacientes tratados con antibióticos administrados por vía sistémica.
    A.3.2Name or abbreviated title of the trial where available
    Estudio PREVAN-ICD
    PREVAN-ICD study
    A.4.1Sponsor's protocol code numberPREVAN
    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 SponsorDra. Julia Origüen Sabater
    B.1.3.4CountrySpain
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Rafael San Juan Garrido
    B.5.2Functional name of contact pointInvestigador Coordinador
    B.5.3 Address:
    B.5.3.1Street AddressU. Enfermedades Infecciosas, CAA, Bloque D, 2ª planta, Hospital 12 de Octubre, Avda Cordoba s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28041
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917792842
    B.5.5Fax number+34913908112
    B.5.6E-mailrafael.san@salud.madrid.org
    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.2.5The 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 nameVancomycin hydrochloride
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVancomicina hidrocloruro
    D.3.9.1CAS number 1404-93-9
    D.3.9.3Other descriptive nameVANCOMYCIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB05077MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients at high risk of recurrence due to CDI who require hospitalization and who increase morbidity and mortality from new CDI.
    Pacientes con alto riesgo de recidivas por ICD que requieren hospitalización y que aumentan la morbimortalidad por nuevas ICD.
    E.1.1.1Medical condition in easily understood language
    Patients at high risk of recurrence due to CDI who require hospitalization and who increase morbidity and mortality from new CDI.
    Pacientes con alto riesgo de recidivas por ICD que requieren hospitalización y que aumentan la morbimortalidad por nuevas ICD.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10072994
    E.1.2Term Clostridium difficile infection recurrence
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of secondary oral vancomycin (OVP) prophylaxis with 125 mg / 6 h is effective compared to placebo in reducing recurrences in patients with a history of Clostrioides Difficile Infection (CDI) and hospitalization in the previous 90 days who require systemic antibiotics during this new hospitalization.
    Evaluar la eficacia de la profilaxis con vancomicina oral (PVO) secundaria con 125 mg/6 h es eficaz respecto a placebo en la reducción de las recidivas en pacientes con antecedentes de Infección por Clostrioides Difficile (ICD) y hospitalización en los 90 días previos que precisen antibióticos sistémicos durante esa nueva hospitalización.
    E.2.2Secondary objectives of the trial
    Efficacy:
    - To assess the efficacy of OVP in patients taking antibiotics after an initial episode of CDI, after a first recurrence and two or more recurrences, that is, to compare the efficacy of secondary prophylaxis according to the degree of recurrent disease.
    - To compare the severity of relapses in both study groups.
    - To compare the efficacy of secondary OVP according to the type of systemic antibiotic with which the study treatment was administered (vancomycin or placebo).
    Safety:
    - To assess the tolerance and safety of OVP (appearance of side effects and difficulty in therapeutic compliance).
    Exploratory:
    - To explore whether primary OVP has an impact on reducing the severity of subsequent CDI episodes.
    Eficacia:
    - Evaluar la eficacia de la PVO en pacientes que toman antibióticos tras un episodio inicial de ICD, después de una primera recidiva y de dos o más recidivas, es decir comparar la eficacia de la profilaxis secundaria según el grado de enfermedad recurrente.
    - Comparar la gravedad de las recidivas en ambos grupos de estudio.
    - Comparar la eficacia de la PVO secundaria según el tipo de antibiótico sistémico junto al cual se administró el tratamiento del estudio (vancomicina o placebo).
    Seguridad:
    - Evaluar la tolerancia y la seguridad de la PVO (aparición de efectos secundarios y dificultad para el cumplimiento terapéutico).
    Exploratorio
    - Explorar si la PVO primaria presenta un impacto en la disminución de la gravedad de los siguientes episodios de ICD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age equal to or greater than 18 years.
    2. History of infection by Clostrioides difficile (CDI) in the previous 90 days.
    3. That requires hospital admission and the need to receive systemic antibiotic treatment (at least 1 day of treatment with at least 1 antimicrobial agent during said admission).
    4. Signature of informed consent.
    1. Edad igual o superior a 18 años.
    2. Antecedentes de episodio de ICD en los 90 días previos.
    3. Que requiera ingreso hospitalario y la necesidad de recibir tratamiento antibiótico sistémico (al menos 1 día de tratamiento con al menos 1 agente antimicrobiano durante dicho ingreso).
    4. Firma de consentimiento informado.
    E.4Principal exclusion criteria
    1. Woman of childbearing age (less than 50 years old, except for those who present a gynecological report proving the presence of menopause) and women who are breastfeeding.
    2. Allergy to vancomycin
    3. Impossibility of complying with the study protocol, including the inability to ingest the capsules or to carry out adequate follow-up, including telephone follow-up or the possibility of transfer to the hospital in less than 48 hours if required.
    4. State of extreme severity or life expectancy of less than 30 days.
    5. Diagnosis of inflammatory bowel disease or other disease that conditions chronic diarrhea.
    6. Criteria for diarrhea (3 or more liquid stools in the last 24 hours) or other clinical and / or microbiological data suggesting CDI at the time of selection or in the previous 3 days.
    7. Antibiotic treatment concomitant or within the previous 5 days with oral vancomycin or other drugs active against C. difficile such as metronidazole, fidaxomicin, tigecycline, fusidic acid, rifaximin or nitazoxanide.
    8. Have received preventive treatment with oral vancomycin or another active drug against C. difficile in the context of systemic antibiotic therapy in the previous 90 days, including fecal material transplantation.
    9. That the patient takes more than 72 hours of systemic antibiotic treatment. If at the time of randomization the patient has been on antibiotic treatment for a longer time, the patient will not be eligible for this study.
    10. Simultaneous participation in another clinical trial using investigational drugs.
    11. Expected systemic antibiotic therapy time greater than 4 weeks
    1. Mujer en edad fértil (menor de 50 años, salvo aquellas que presenten un informe ginecológico que acredite la presencia de menopausia) y mujeres en periodo de lactancia.
    2. Alergia a vancomicina
    3. Imposibilidad de cumplir con el protocolo del estudio incluyendo la imposibilidad de ingerir las cápsulas o de realizar el seguimiento adecuado, incluyendo el seguimiento telefónico o la posibilidad de traslado al centro hospitalario en un plazo inferior a 48 horas si sí se requiere.
    4. Estado de gravedad extrema o expectativa de vida inferior a 30 días.
    5. Diagnóstico de enfermedad inflamatoria intestinal o de otra enfermedad que condicione diarrea crónica.
    6. Criterios de diarrea (3 o más deposiciones líquidas en las últimas 24 horas) u otros datos clínicos y/o microbiológicos que sugieran ICD en el momento de la selección o en los 3 días previos.
    7. Tratamiento antibiótico concomitante o en los 5 días previos con vancomicina oral u otros fármacos activos frente a C. difficile como metronidazol, fidaxomicina, tigeciclina, ácido fusídico, rifaximina o nitazoxanida.
    8. Haber recibido tratamiento preventivo con vancomicina oral u otro fármaco activo frente a C. difficile en el contexto de antibioterapia sistémica en los 90 días previos, incluyendo trasplante de material fecal.
    9. Que el paciente lleve más de 72 horas de tratamiento antibiótico sistémico. Si en el momento de la aleatorización el paciente lleva más tiempo de tratamiento antibiótico el paciente no será elegible para este estudio.
    10. Participación simultánea en otro ensayo clínico que utilice fármacos de investigación.
    11. Tiempo de antibioterapia sistémica prevista mayor de 4 semanas
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint
    Incidence of new CDI episodes 60 days after completion of study treatment.
    Variable principal de eficacia
    Incidencia de nuevos episodios de ICD a los 60 días de finalización del tratamiento del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 days after the end of study treatment.
    60 días después de finalizar el tratamiento del estudio.
    E.5.2Secondary end point(s)
    Secondary Efficacy variables
    1. Incidence of new episodes of severe CDI or fulminant colitis 60 days after the end of prophylaxis.
    2. Incidence of new episodes of diarrhea without definitive diagnosis of CDI 60 days after the end of study treatment.
    Secondary safety variables
    1. Incidence of adverse reaction to study drugs.
    2. Percentage of patients who voluntarily abandon study drugs.
    Variables secundarias de Eficacia
    1. Incidencia de nuevos episodios de ICD grave o colitis fulminante (3.2.5) a los 60 días de finalizada la profilaxis.
    2. Incidencia de nuevos episodios de diarrea (3.2.1.1) sin diagnóstico definitivo de ICD a los 60 días de finalizado el tratamiento del estudio.
    Variables secundarias de seguridad
    1. Incidencia de reacción adversa a los fármacos del estudio.
    2. Porcentaje de pacientes que abandonan voluntariamente los fármacos del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 days after the end of study treatment.
    60 días después de finalizar el tratamiento del estudio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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
    LVLS
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state108
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 108
    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)
    None.
    Ninguno.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
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