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    Summary
    EudraCT Number:2013-005536-17
    Sponsor's Protocol Code Number:IIBSP-CIP-2013-166
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-06
    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 number2013-005536-17
    A.3Full title of the trial
    Multicenter, randomized and double-blinded clinical trial on the use of antibiotic prophylaxis for EUS guided FNA of pancreatic cystic lesions
    Ensayo clínico multicéntrico, aleatorizado y doble ciego sobre el uso de antibiótico profiláctico en la punción por ecoendoscopia de lesiones quísticas del páncreas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of antibiotic prophylaxis for EUS- FNA of pancreatic cystic lesions
    Uso de antibiótico profiláctico en la punción por ecoendoscopia de lesiones quísticas del páncreas
    A.4.1Sponsor's protocol code numberIIBSP-CIP-2013-166
    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 SponsorInstitut de Recerca de l'Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau
    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 supportInstitut de Recerca de l'Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau
    B.4.2CountrySpain
    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 organisationInstitut de Recerca de l'Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau
    B.5.2Functional name of contact pointClinical Trial Assistant
    B.5.3 Address:
    B.5.3.1Street Addressc/ Sant Antoni Maria Claret, 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number0034935537636
    B.5.5Fax number0034935537812
    B.5.6E-mailepenag@santpau.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Ciprofloxacino Kabi 2 mg/ml solución para perfusión EFG
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi España, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCIPROFLOXACIN
    D.3.9.1CAS number 85721-33-1
    D.3.9.3Other descriptive nameCIPROFLOXACIN (AS HCL, H2O)
    D.3.9.4EV Substance CodeSUB70719
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Ciprofloxacino Normon 500 mg comprimidos recubiertos con película EFG
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS NORMON, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Coated tablet
    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 INNCIPROFLOXACIN
    D.3.9.1CAS number 85721-33-1
    D.3.9.3Other descriptive nameCIPROFLOXACIN
    D.3.9.4EV Substance CodeSUB07470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    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
    Pancreatic cystic lesions
    Lesiones quísticas del páncreas
    E.1.1.1Medical condition in easily understood language
    Pancreatic cystic lesions
    Lesiones quísticas del páncreas
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    To investigate if the EUS-FNA of pancreatic cystic lesions without antimicrobial prophylaxis does not increase the risk of infection compared to the same procedure with antimicrobial prophylaxis.
    Investigar si la USE-PAAF de lesiones quísticas pancreáticas sin profilaxis antimicrobiana no aumenta el riesgo de infección en comparación con el mismo procedimiento con la profilaxis antimicrobiana.
    E.2.2Secondary objectives of the trial
    1. To assess the risk of fever after EUS-FNA of a pancreatic cyst with and without antimicrobial prophylaxis.
    2. To assess secondary effects related to the use of prophylaxis (secondary effects, allergic reactions, and drug resistant or secondary infections)
    3. To assess other complications of the procedure (bleeding, perforation).
    1. Evaluar el riesgo de fiebre después de la USE-PAAF de un quiste pancreático, con y sin profilaxis antimicrobiana.
    2. Evaluar los efectos secundarios relacionados con el uso de la profilaxis (efectos secundarios, reacciones alérgicas, y las infecciones resistentes o secundarios de la droga)
    3. Evaluar otras complicaciones del procedimiento (hemorragia, perforación).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with a pancreatic cyst requiring EUS-FNA to complete evaluation.
    - Participant is willing and able to give informed consent for participation in the study.
    - Age 18 years or older.
    - Ability to understand study procedures and to comply with them for the entire length of the study.
    - Pacientes con quiste pancreático que requieren EUS-FNA para completar su evaluación.
    - Participante dispuesto y capaz de dar su consentimiento informado para la participación en el estudio.
    - Edad 18 años o más.
    - Capacidad para comprender los procedimientos del estudio y para cumplir con ellos para toda la duración del estudio.
    E.4Principal exclusion criteria
    - Patients with other co-morbidities requiring antibiotic prophylaxis for endoscopic invasive procedures (such as those with cardiac valve prosthesis).
    - Cystic lesion of the intestinal wall (foregut or duplication cyst).
    - Use of antibiotic treatment for any other indication during the 5 days prior to the procedure.
    - Pregnant woman.
    - Known allergy/sensitivity to ciprofloxacin.
    - Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
    - Pacientes con otras enfermedades concomitantes que requieren profilaxis antibiótica para procedimientos invasivos endoscópicos (tales como aquellos con prótesis de válvula cardiaca).
    - Lesión quística de la pared intestinal (intestino anterior o quiste de duplicación).
    - Uso de tratamiento con antibióticos para cualquier otra indicación durante los 5 días previos al procedimiento.
    - Embarazo.
    - Alergia / sensibilidad conocida a ciprofloxacino.
    - Incapacidad o negativa del tutor / representante persona física o jurídica para dar su consentimiento informado por escrito.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of infection of pancreatic cyst: expressed as a percentage. Infection was defined as "confirmed" positive culture if the content of the lesion or suspected by clinical or imaging techniques (CT, MRI) and no positive blood culture. Be defined as "suspicious" when there is clinical suspicion and / or suggestive image of cyst infection, but laboratory confirmation is obtained.
    Incidencia de infección del quiste pancreático: se expresará en porcentaje. La infección se definirá como "confirmada" en caso de cultivo positivo del contenido de la lesión o si se sospecha por clínica o mediante técnicas de imagen (TAC, RM) y hay cultivo positivo en sangre. Se definirá como "sospechosa" cuando haya sospecha clínica y/o imagen sugestiva de infección del quiste, pero no se obtenga confirmación microbiológica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    21 days
    21 días
    E.5.2Secondary end point(s)
    Risk of fever
    Other complications (as bleeding or perforation)
    Secondary effects related to the use of prophylaxis (secondary effects, allergic reactions, and drug resistant or secondary infections)
    Riesgo de fiebre
    Otras complicaciones (como sangrado o perforación)
    Los efectos secundarios relacionados con el uso de la profilaxis (efectos secundarios, reacciones alérgicas, y las infecciones resistentes o secundarios de la droga)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The evaluation of the secondary outcomes will be performed during the procedure and all the follow up period (21 days), and the follow up will be extended until it is solved.
    La evaluación de los resultados secundarios se realizará durante el procedimiento y todo el período de seguimiento (21 días), y el seguimiento se extenderá hasta que sea resuelto.
    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 No
    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 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 concerned5
    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
    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: 218
    F.1.3Elderly (>=65 years) No
    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 state218
    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)
    The expected normal treatment of that condition
    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 Decision2014-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-31
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