임상 시험 Nct 페이지

Summary
EudraCT Number:2014-003882-10
Sponsor's Protocol Code Number:2014_21
National Competent Authority:France - ANSM
Clinical Trial Type:EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:2015-07-29
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
A. Protocol Information
A.1Member State ConcernedFrance - ANSM
A.2EudraCT number2014-003882-10
A.3Full title of the trial
Evaluation of the effectiveness of a treatment involving one (or several ) antibiotic (s) with 14-day tobramycin ( Nebcine® ) by intravenous injection versus the same antibiotic treatment (s ) associated with only 5 days of tobramycin ( Nebcine® ) by intravenous injection followed tobramycin aerosol ( Tobi® ) for 9 days in the context of cystic fibrosis
Evaluation de l’efficacité d’une cure associant un (ou plusieurs) antibiotique(s)avec 14 jours de tobramycine (Nebcine®) en injection intra-veineuse versus la même cure d’antibiotique(s) associée à seulement 5 jours de tobramycine (Nebcine®) en injection intra-veineuse suivi d’aérosols de tobramycine (Tobi®) pendant 9 jours dans le cadre de la mucoviscidose
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Evaluation of the efficacy of antibiotic treatments associated with the Nebcine® as intravenous injection only and / or monitoring of aerosols of Tobi® in order to optimize the therapeutic management of exacerbations in patients with cystic fibrosis .
Evaluation de l'efficacité de traitements antibiotiques associée à de la Nebcine® en injection intra veineuse seule et/ou suivi d'aérosols de Tobi® dans le but d'optimiser la prise en charge thérapeutique des exacerbations chez les patients atteints de mucoviscidose.
A.3.2Name or abbreviated title of the trial where available
TOBRAMUC
A.4.1Sponsor's protocol code number2014_21
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 SponsorCHRU de Lille
B.1.3.4CountryFrance
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 supportCHRU de Lille
B.4.2CountryFrance
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationCHRU de Lille
B.5.2Functional name of contact pointFédération de Recherche Clinique
B.5.3 Address:
B.5.3.1Street Address6 rue du Pr Laguesse
B.5.3.2Town/ cityLille
B.5.3.3Post code59037 Cedex
B.5.3.4CountryFrance
B.5.4Telephone number0033320444145
B.5.5Fax number0033320445711
B.5.6E-maildrc@chru-lille.fr
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 NEBCINE
D.2.1.1.2Name of the Marketing Authorisation holderEREMPHARMA
D.2.1.2Country which granted the Marketing AuthorisationFrance
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 nameNEBCINE
D.3.4Pharmaceutical form Solution 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.3.9.1CAS number 32986-56-4
D.3.9.3Other descriptive nameTOBRAMYCIN
D.3.9.4EV Substance CodeSUB11134MIG
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number100
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 NEBCINE
D.2.1.1.2Name of the Marketing Authorisation holderEREMPHARMA
D.2.1.2Country which granted the Marketing AuthorisationFrance
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 nameNEBCINE
D.3.4Pharmaceutical form Solution 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.3.9.1CAS number 32986-56-4
D.3.9.3Other descriptive nameTOBRAMYCIN
D.3.9.4EV Substance CodeSUB11134MIG
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number100 to 0
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: 3
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 NEBCINE
D.2.1.1.2Name of the Marketing Authorisation holderEREMPHARMA
D.2.1.2Country which granted the Marketing AuthorisationFrance
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 nameNEBCINE
D.3.4Pharmaceutical form Solution 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.3.9.1CAS number 32986-56-4
D.3.9.3Other descriptive nameTOBRAMYCIN
D.3.9.4EV Substance CodeSUB11134MIG
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number100
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: 4
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 NEBCINE
D.2.1.1.2Name of the Marketing Authorisation holderEREMPHARMA
D.2.1.2Country which granted the Marketing AuthorisationFrance
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 nameNEBCINE
D.3.4Pharmaceutical form Solution 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.3.9.1CAS number 32986-56-4
D.3.9.3Other descriptive nameTOBRAMYCIN
D.3.9.4EV Substance CodeSUB11134MIG
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number100
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: 5
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 TOBI
D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS PHARMA SAS
D.2.1.2Country which granted the Marketing AuthorisationFrance
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 nameTOBI
D.3.4Pharmaceutical form Nebuliser solution
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPInhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1CAS number 32986-56-4
D.3.9.3Other descriptive nameTOBRAMYCIN
D.3.9.4EV Substance CodeSUB11134MIG
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number300
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
mucoviscidosis or cystic fibrosis
Mucoviscidose
E.1.1.1Medical condition in easily understood language
mucoviscidosis or cystic fibrosis
Mucoviscidose
E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 18.0
E.1.2Level LLT
E.1.2Classification code 10068288
E.1.2Term Cystic fibrosis pulmonary exacerbation
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
Tester la non infériorité d’une cure d’antibiotiques avec 5 jours de tobramycine (Nebcine®) en injection intra-veineuse suivi de 9 jours d’aérosols de tobramycine (Tobi®) par rapport à une cure d’antibiotiques classique ( 14 jours en injection intra-veineuse).
E.2.2Secondary objectives of the trial
Evaluation de :
- l’efficacité clinique de la cure ressentie par le patient
- de l’intervalle entre deux exacerbations
- de la survenue de résistances bactériennes
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
• Patient homme ou femme
• Age > 8 ans (pas de limite d’âge de participation)
• Patient atteint de mucoviscidose confirmée par test de la sueur ou génétique
• Patient porteur chronique de Pseudomonas aeruginosa (définie par au moins deux arcs de précipitation antipyocyanique ou au moins 3 ECBC positifs sur une période de 6 mois)
• Patient ayant bénéficié d’au moins 1 cure IV d’antibiotiques dans l’année précédant l’inclusion.
• Consentement éclairé du patient et le cas échéant celui de ses représentants légaux.
• Patient assuré social
E.4Principal exclusion criteria
• Patient ayant refusé de participer à l’étude après information.
• Patient sous tutelle ou curatelle
• Patient en situation d’urgence (dans l’incapacité physique de consentir)
• Femme enceinte ou allaitante
• Patient intolérant à la Tobramycine
• Patient colonisé à Burkholderia cepacia
• Patient colonisé par une mycobactérie atypique
• Patient ayant bénéficié d’une transplantation pulmonaire ou inscrit sur liste de transplantation
• Antécédent d’hémoptysie sévère récente (dans les 2 mois précédant l’inclusion)
• Cures d’antibiotiques prescrites de manière systématique
• Patient ne devant pas participer de manière simultanée à une autre étude clinique menée sur un médicament pendant toute la durée de sa participation à cette recherche (les études non interventionnelles et/ou qui n’influent pas sur les critères d’évaluation de l’étude seront acceptées)
E.5 End points
E.5.1Primary end point(s)
Le critère principal de l’étude est la variation du VEMS avant (J0) et après la cure (J16).
E.5.1.1Timepoint(s) of evaluation of this end point
J0 and J16
J0 et J16
E.5.2Secondary end point(s)
Les critères d’évaluation secondaires sont :
• L’évaluation de l’efficacité clinique de la cure sur des échelles visuelles analogiques (dyspnée, encombrement) et évaluation de l’état général (avec mesure du poids, SaO2, EVA)
• La durée avant la survenue de la prochaine exacerbation (intervalle de temps mesuré en jours entre les deux consultations/hospitalisation pour exacerbation)
• L’examen cytobactériologique des expectorations (ECBC) à J1 et J17 de chacune des deux cures.
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 Yes
E.6.13.1Other scope of the trial description
Strategy
Stratégie
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) Yes
E.7.3Therapeutic confirmatory (Phase III) No
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 Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over Yes
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
Essai de stratégie : efficacité d’une cure d’antibiotiques avec 5 jours de tobramycine (Nebcine®) en
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 concerned7
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
End of the trial: last visit of the last subject
Fin de l'étude désignée par la dernière visite du dernier patient
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 months10
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 Yes
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) Yes
F.1.1.6Adolescents (12-17 years) Yes
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
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 state87
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 Decision2015-07-01
N.Ethics Committee Opinion of the trial application
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial Status

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