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    Summary
    EudraCT Number:2018-001376-38
    Sponsor's Protocol Code Number:LOCKIA
    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:2019-07-04
    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 number2018-001376-38
    A.3Full title of the trial
    Antimicrobials Local Administration for Intraabdominal Abscesses Treatment: Controlled, Randomized, Open, Parallel Groups, Clinical Trial
    Administración Local de Antimicrobianos para el Tratamiento de los Abscesos
    Intraabdominales: Ensayo Clínico Controlado, Aleatorizado, Abierto, de Grupos Paralelos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antimicrobials Local Administration for Intraabdominal Abscesses Treatment
    Administración Local de Antimicrobianos para el Tratamiento de los Abscesos
    Intraabdominales
    A.4.1Sponsor's protocol code numberLOCKIA
    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 SponsorMaría Dolores Sousa Regueiro
    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 supportMaría Dolores Sousa Regueiro
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaría Dolores Sousa Regueiro
    B.5.2Functional name of contact pointUnidad de Enfermedades Infecciosas
    B.5.3 Address:
    B.5.3.1Street AddressC/ Xubias de arriba, 84
    B.5.3.2Town/ cityA Coruña
    B.5.3.3Post code15006
    B.5.3.4CountrySpain
    B.5.4Telephone number+34981178157
    B.5.6E-mailDolores.Sousa.Regueiro@sergas.es
    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 Yes
    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 Powder for injection
    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 INNMEROPENEM
    D.3.9.1CAS number 96036-03-2
    D.3.9.3Other descriptive nameMEROPENEM
    D.3.9.4EV Substance CodeSUB08778MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500 to 1000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Intra-abdominal abscesses
    Abcesos intraabdominales
    E.1.1.1Medical condition in easily understood language
    Intra-abdominal abscesses
    Abcesos intraabdominales
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    Determine the clinical response of the addition of local antibiotic therapy to the standard treatment of intra-abdominal abscesses
    Determinar la respuesta clínica de la adición de antibioterapia local al tratamiento estándar de los abscesos intraabdominales.
    E.2.2Secondary objectives of the trial
    - Determine the time until microbiological eradication
    / negativization of cultures in the groups under study
    - Study the development of clinical complications: severe sepsis,
    kidney failure, others.
    - To establish if local antibiotic therapy addition reduces the risk of
    subsequent invasive or surgical procedures; such as:
    percutaneous drains, endoscopic drainage or open laparotomy.
    - Assess systemic antimicrobial use by episode
    − Determinar el tiempo hasta la erradicación microbiológica
    /negativización de los cultivos en los grupos a estudio
    − Estudiar el desarrollo de complicaciones clínicas: sepsis grave,
    insuficiencia renal, otras.
    − Establecer si la adición de antibioterapia local reduce el riesgo de
    procedimientos invasivos o quirúrgicos subsecuentes; tales como:
    drenajes percutáneos, drenajes vía endoscópica o laparotomía abierta.
    − Valorar el consumo de antimicrobianos por vía sistémica por episodio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - to be 18 years old or more
    - Intra-abdominal abscesses of any etiology that require
    drainage catheter placement
    - Signature of the specific Informed Consent of the trial
    - Edad igual o superior a 18 años
    - Abscesos intraabdominales de cualquier etiología que requieran
    colocación de catéter de drenaje
    - Firma del Consentimiento Informado específico del ensayo.
    E.4Principal exclusion criteria
    - Need for early open surgery (laparotomy)
    - Patients with systemic embolisms or multiple foci of infection
    - Impossibility of performing antibiotic sealing for at least 3-4
    hours continuously if an antibiotic with activity is used
    time-dependent
    - Pregnant women
    - Necesidad de cirugía abierta (laparotomía) temprana
    - Pacientes con embolismos sistémicos o múltiples focos de infección
    - Imposibilidad de realizar sellado antibiótico durante al menos 3-4
    horas de forma continua si se emplea un antibiótico con actividad
    tiempo-dependiente
    - Mujeres embarazadas
    E.5 End points
    E.5.1Primary end point(s)
    Better clinical response with the addition of local antibiotic therapy to the standard treatment of intra-abdominal abscesses.
    Mejor respuesta clínica con la adición de antibioterapia local al tratamiento estándar de los abscesos intraabdominales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An evaluation of the end of treatment will be carried out and 1 month after the last administration of the antibiotic.
    Se realizará una evaluación de fin de tratamiento y a 1 mes después de la última administración del antibiótico.
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Se compararán los mismos antimicrobianos en diferentes formas de uso
    Same antimicrobials will be compared in different ways of use
    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
    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: 125
    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 state125
    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)
    Not different from the expected normal treatment of that condition
    No difiere del tratamiento normal esperado para dicha condición
    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 Decision2019-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-27
    P. End of Trial
    P.End of Trial StatusOngoing
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