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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2012-003511-63
    Sponsor's Protocol Code Number:IJG-PEN-2012
    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:2012-09-14
    Trial results View 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 number2012-003511-63
    A.3Full title of the trial
    Efficacy of high doses of oral penicillin V versus high dose amoxicillin in the treatment of non-severe pneumonia treated at the adult community.PENIPNEUMO Study
    Eficacia de dosis altas de penicilina V oral frente a amoxicilina a dosis altas en el tratamiento de
    la neumonía no grave atendida en la comunidad en adultos.Estudio PENIPNEUMO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of penicillin versus hi amoxicillin in the pneumonia treated
    Eficacia de la penicilina en comparación a la amoxicilian en neumonía
    A.3.2Name or abbreviated title of the trial where available
    PENIPNEUMO
    PENIPNEUMO
    A.4.1Sponsor's protocol code numberIJG-PEN-2012
    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 SponsorIDIAP Jordi Gol
    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 Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIDIAP Jordi Gol
    B.5.2Functional name of contact pointRosa Morros
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes 587
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08007
    B.5.3.4CountrySpain
    B.5.4Telephone number34934824117
    B.5.6E-mailrmorros@idiapjgol.org
    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 Penilevel
    D.2.1.1.2Name of the Marketing Authorisation holderERN
    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 Capsule
    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 INNPHENOXYMETHYLPENICILLIN POTASSIUM
    D.3.9.1CAS number 132-98-9
    D.3.9.2Current sponsor code660837
    D.3.9.4EV Substance CodeSUB03766MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1600000
    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 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 Amoxiciline
    D.2.1.1.2Name of the Marketing Authorisation holderSiemsgluss
    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 Capsule
    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 INNAMOXICILLIN
    D.3.9.1CAS number 26787-78-0
    D.3.9.2Current sponsor code858266
    D.3.9.4EV Substance CodeSUB05481MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    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 between 18-65 years with lower respiratory tract infection and radiologically confirmed diagnosis of pneumonia
    pacientes entre 18 y 65 años con infección del tracto respiratorio inferior y que radiológicamente se confirma el diagnóstico de neumonía
    E.1.1.1Medical condition in easily understood language
    Patients with pneumonia
    Paciente con neumomía
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 evaluate the efficacy of phenoxymethylpenicillin (penicillin V) high-dose antibiotic treatment in non-severe pneumonia treated in the community versus high-dose amoxicillin considering clinical cure within two weeks
    Evaluar la eficacia de fenoximetilpenicilina (penicilina V) a dosis altas en el tratamiento antibiótico de la neumonía no grave atendida en la comunidad y compararlo con amoxicilina a dosis altas considerando la curación clínica a las dos semanas
    E.2.2Secondary objectives of the trial
    To evaluate the radiological healing and clinical cure in both treatment groups at four weeks of antibiotic treatment instituted. To evaluate the adverse effects on patients treated with both treatment groups
    Evaluar la resolución radiológica y la curación clínica de ambos grupos de tratamiento a las cuatro semanas de haber instaurado el tratamiento antibiótico. Evaluar los efectos secundarios y adversos en los pacientes tratados con ambos grupos de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients 18 years to 65 years (inclusive).
    Signs and symptoms of lower respiratory tract infection.
    Radiological confirmation of the diagnosis of pneumonia or not radiological confirmation but the patient has the following symptoms: high fever (> 38.5 ° C), cough and purulent sputum and auscultation of crackles in a pulmonary focus, the researcher undertakes to confirm after inclusion pneumonia with mandatory radiological study.
    Signature of informed consent.
    Edad entre 18 y 65 años (ambos incluidos).
    Presenta signos y síntomas de infección del tracto respiratorio inferior.
    Confirmación radiológica del diagnóstico de neumonía o no confirmación radiológica pero el paciente presenta los siguientes síntomas: fiebre elevada (>38.5ºC), tos y expectoración purulenta y auscultación de crepitantes en un foco pulmonar; el investigador se compromete a confirmar tras la inclusión la neumonía con el estudio radiológico preceptivo.
    Firma del consentimiento informado.
    E.4Principal exclusion criteria
    ? Impaired consciousness: confused state, delirium, drowsiness, stupor or coma, at medical discretion
    ? Respiratory rate> 30 breaths / minute
    ? Heart rate> 125 beats / minute
    ? Systolic blood pressure <90 mm ??Hg or diastolic <60 mm Hg
    ? Hypersensitivity to ?-lactam
    ? O2 saturation <92%
    ? axillary temperature > 40 ° C
    ? Bronchial Asthma
    ? Pregnancy or breastfeeding
    ? Comorbidity significant: renal failure, liver cirrhosis, heart failure, chronic obstructive pulmonary disease, ischemic heart disease, stroke and / or diabetes mellitus type 1
    ? Important alteration in chest radiography: alveolar infiltrates in more than one lobe or bilateral pleural effusion or pulmonary cavitation
    ? Problems in order to meet the treatment at home: sociopathy or psychiatric problems, drug and alcohol addiction, or a family environment unsuitable
    ? Lack of tolerance to oral therapy: presence of nausea and vomiting, gastrectomy, post-surgery or frank diarrhea
    ? Immunosuppression: chronic HIV infection, transplant, neutropenic, or patients receiving immunosuppressive
    ? active Neoplasia
    ? Terminal illness
    ? Hospitalisation in the last month
    ? Taking antibiotics in the two weeks prior to the inclusion
    ? Difficulty to attend follow-up visits
    ? Refusal to participate in the study
    ? Alteración de la conciencia: estado confuso, delirio, obnubilación, estupor o coma , bajo criterio del investigador
    ? Frecuencia respiratoria> 30 respiraciones/minuto
    ? Frecuencia cardíaca > 125 latidos/minuto
    ? Tensión arterial sistólica < 90 mm Hg o diastólica < 60 mm Hg
    ? Hipersensibilidad a los ?-lactámicos
    ? Saturación de O2< 92%
    ? Temperatura axilar >40ºC
    ? Asma bronquial
    ? Embarazo o lactancia
    ? Comorbilidad significativa: insuficiencia renal, cirrosis hepática, insuficiencia cardíaca, enfermedad pulmonar obstructiva crónica, cardiopatía isquémica, accidente cerebrovascular y/o diabetes mellitus tipo 1
    ? Alteración importante en la radiografía de tórax: infiltrado alveolar en más de un lóbulo o bilateral, derrame pleural o cavitación pulmonar
    ? Problemas en poder cumplir el tratamiento en el domicilio: sociopatía o problemas psiquiátricos, adicción a drogas y alcohol, o bien, un entorno familiar no adecuado
    ? Falta de tolerancia al tratamiento por vía oral: presencia de náuseas y vómitos, gastrectomía, post-cirugía o diarrea franca
    ? Inmunosupresión: infección crónica por VIH, trasplantados, neutropénicos, o bien, pacientes que reciben tratamiento inmunosupresor
    ? Neoplasia activa
    ? Enfermedad terminal
    ? Hospitalización en el último mes
    ? Toma de antibióticos en las dos semanas previas a la inclusión
    ? Dificultad para acudir a las visitas de seguimiento
    ? Negación a participar en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Clinical resolution at 14 days (visit 2 monitoring), defined as disappearance of fever, disappearance or improvement of cough, improvement of general condition and disappearance or reduction of auscultation of crackles, so no need to add any other treatment antimicrobial. Any other clinical outcome does not obey the above definition is considered treatment failure
    Resolución clínica a los 14 días (visita 2 de seguimiento), definida como desaparición de fiebre, desaparición o mejoría de la tos, mejoría del estado general y desaparición o disminución de la auscultación de crepitantes, de manera que no es necesario añadir ningún otro tratamiento antimicrobiano. Cualquier otro resultado clínico que no obedezca a la definición anterior se considerará fracaso del tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days
    14 dias
    E.5.2Secondary end point(s)
    Effectiveness month after initiation of antibiotic treatment (visit 3 tracking). It is considered the same definition as in the primary and will be defined by the researcher at visit 3 tracking based on medical history and physical examination.
    ? Resolution radiological month after initiation of antibiotic treatment (visit 3-up), defined by the investigator and / or radiologist as complete or partial resolution of pulmonary condensation image.
    ? total clinical resolution at 14 days (visit 2-up), defined as complete resolution of signs and symptoms related to acute infection so that it is not necessary to add any antimicrobial treatment.
    ? total clinical resolution a month after starting antibiotic treatment (visit 3 tracking). It will be defined by the researcher at visit 3 tracking based on medical history and physical examination.
    ? Eficacia al mes de haber iniciado el tratamiento antibiótico (visita 3 de seguimiento). Se considera la misma definición que en la variable principal y será definida por el investigador en la visita 3 de seguimiento en base a la historia clínica y la exploración física.
    ? Resolución radiológica al mes de haber iniciado el tratamiento antibiótico (visita 3 de seguimiento), definido por el investigador y/o radiólogo como resolución completa o parcial de la imagen de condensación pulmonar.
    ? Resolución clínica total a los 14 días (visita 2 de seguimiento), definida como resolución total de los síntomas y signos agudos relacionados con la infección de manera que no es necesario añadir ningún otro tratamiento antimicrobiano.
    ? Resolución clínica total al mes de haber iniciado el tratamiento antibiótico (visita 3 de seguimiento). Será definida por el investigador en la visita 3 de seguimiento en base a la historia clínica y la exploración física.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days
    30 dias
    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 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) Yes
    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 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 concerned2
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state210
    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
    No
    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 Decision2013-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
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