Page Nct des essais cliniques

Summary
EudraCT Number:2005-004973-55
Sponsor's Protocol Code Number:ANTIVORIFUNGOL
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:2006-07-04
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2005-004973-55
A.3Full title of the trial
ESTRATEGIA DE MANEJO ANTIFUNGICO DEL PACIENTE ONCOHEMATOLOGICO NEUTROPENICO. EMPLEO DE VORICONAZOL COMO TRATAMIENTO ANTICIPADO.
A.4.1Sponsor's protocol code numberANTIVORIFUNGOL
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorFUNDACION PETHEMA
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 support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
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 Information not present in EudraCT
D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameVFEND
D.3.4Pharmaceutical form Tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntravenous use
Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNVFEND
D.3.9.2Current sponsor codeANTIVORIFUNGOL
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.3Concentration number40,50,200
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
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
Estrategia de manejo antifungico de amplio espectro del paciente oncohemtologico neutropencio. Voriconazol como tratamiento anticipado.
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
El objetivo principal sería confirmar que esta estrategia consigue disminuir el uso empírico de antifúngicos de amplio espectro en fase precoz de la neutropenia febril, con una incidencia igual o inferior de IFI a la obtenida con el uso tradicional de antifúngicos empíricos, con una menor toxicidad renal sin incrementar otras toxicidades (hepática) y con un menor gasto de antifúngicos en conjunto.
Frecuencia del empleo de antifúngicos de amplio espectro en el episodio de neutropenia.
E.2.2Secondary objectives of the trial
-Evaluar la seguridad y toxicidad de Voriconazol
- Frecuencia de empleo global de antifúngicos de amplio espectro como son anfotericina, itraconazol, voriconazol, caspofungina, terbinafina (engloba a los empleados de forma empírica, dirigida por galactomanano / TAC, o de forma terapéutica) durante el periodo de estudio
- Mortalidad
- Desarrollo de nefrotoxicidad
- Desarrollo hepatotoxicidad
- Tiempo a administración de terapia antifúngica empírica de amplio espectro
- La evaluación de los recursos sanitarios consumidos por las estrategias evaluables
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- Firma del consentimiento informado para participar en el estudio
-Pacientes adultos y pediátricos (a partir de 2 años), diagnosticados de neoplasia hematológica o tumor sólido
-Pacientes que desarrollarán neutropenia (<500 PN) post quimioterapia o post-TPH
-Pacientes seguidos con galactomanano en sangre bisemanal
-Terapia antibacteriana empírica de amplio espectro
-El paciente debe incluirse en este protocolo de manejo antifúngico desde el inicio de su quimioterapia o terapia de acondicionamiento.
- Test de embarazo negativo en pacientes en edad fértil
E.4Principal exclusion criteria
-Empleo de profilaxis antifúngica con triazoles con actividad frente Aspergillus
-Empleo profiláctico de fluconazol a dosis superiores a 100 mg/día
-Alergia a los azoles.
-Presentar una infección fúngica invasora al inicio del episodio de neutropenia febril.
-Alta incidencia en la unidad de aislamientos de Candida resistentes al fluconazol
-Neutropenias producidas por anemia aplásica u otros fallos medulares
-Inclusión previa en este estudio
-Se excluirán los pacientes colonizados por Aspergillus, C.krusei o C.glabrata
-Recibir fármacos que están contraindicados con el voriconazol y/o con el fluconazol
-que finalmente tengan una neutropenia de corta duración
E.5 End points
E.5.1Primary end point(s)
Frecuencia del empleo de antifúngicos de amplio espectro (anfotericina, voriconazol, itraconazol, caspofungina, terbinafina) durante en el episodio de neutropenia.
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 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 Information not present in EudraCT
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic Yes
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Information not present in EudraCT
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised No
E.8.1.2Open Information not present in EudraCT
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Information not present in EudraCT
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over Information not present in EudraCT
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Information not present in EudraCT
E.8.2.2Placebo Information not present in EudraCT
E.8.2.3Other Information not present in EudraCT
E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
E.8.5The trial involves multiple Member States Information not present in EudraCT
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
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
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 months22
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 Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-07-04. Yes
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
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 state115
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 Decision2006-08-18
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-06-13
P. End of Trial
P.End of Trial StatusOngoing

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