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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   39219   clinical trials with a EudraCT protocol, of which   6426   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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    EudraCT Number:2008-004150-32
    Sponsor's Protocol Code Number:A8851008
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-13
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2008-004150-32
    A.3Full title of the trial
    A.4.1Sponsor's protocol code numberA8851008
    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 SponsorPfizer Inc, 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc.
    B.4.2CountryUnited States
    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 Yes
    D. name ECALTA ®
    D. of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INN1 [(4R,5R)-4,5-dihydroxy-N2-[[4"-(pentyloxy)[1,1':4',1 "-terphenyl]-4-yl]carbonyl]-L-ornithine] echinocandin B
    D.3.9.1CAS number 166663-25-8
    D.3.9.2Current sponsor codePF-03910960
    D.3.9.3Other descriptive nameAnidulafungin
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 No
    D.3.11.8Extractive medicinal product No
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064954
    E.1.2Term Invasive candidiasis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the safety and tolerability of anidulafungin when used to treat children with invasive candidiasis, including candidemia.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of anidulafungin, as measured by global response, at the following time points: EOIVT, end of treatment (EOT), 2-week follow-up (FU) visit and 6-week FU visit;
    • To explore pharmacokinetic parameters of anidulafungin in children aged 1 month to <2 years following IV infusion of anidulafungin (AUC24 and Cmax);
    • To explore the exposure-response (safety and efficacy endpoints) relationship of anidulafungin using a nonlinear mixed effects approach as appropriate, including exploring the association between PK-PD index (eg, AUC/MIC) and efficacy endpoints;
    • To assess rates of relapse at the Week 2 and Week 6 FU visits;
    • To assess rates of new infection at the Week 2 and Week 6 FU visits;
    • To assess all-cause mortality during study therapy and Follow-Up visits.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A sub-study to explore the pharmacokinetic parameters in children aged 1 month to <2 years will be performed on a limited number of subjects prior to complete enrollment of this age group in this study.First 6 subjects enrolled in this age category will have PK-PD samples drawn. Samples will be analyzed in real time and results reviewed prior to enrolling additional subjects in this age cohort. This is all part of the A8851008 study.
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Diagnosis of invasive candidiasis/candidemia (ICC) based on the growth of Candida sp. from a blood and/or tissue culture obtained from a normally sterile site taken within 96 hours before study entry.
    Diagnosis will be based on presence of at least one of the following:
    • Candidemia: at least one blood culture positive for Candida sp. (in the absence of other demonstrated foci of infection) or;
    • Other forms of invasive candidiasis: positive culture for Candida sp. from a specimen from a normally sterile site with or without a positive blood culture; positive culture fpr Candida sp. plus ophthalmic examination consistent with Candida endophthalmitis
    NOTE: Positive cultures for Candida sp. from sputum (including those obtained by bronchoalveolar lavage or an endotracheal aspirate) will not qualify as a positive culture.
    At least one of the following:
    • A fever defined as an oral/tympanic temperature ≥100.4°F (38.0°C), rectal temperature ≥101.4°F (38.6°C) or an axillary temperature ≥99.4°F (37.4°C);
    • Hypothermia defined as a temperature less than 96.8°F (36.0°C);
    • A systolic blood pressure of less than 100% for age and gender norms (per National High Blood Pressure Education Program (NHBPEP) Working Group on Children and Adolescents guidelines);
    • Signs or symptoms of candidemia/invasive candidiasis which may include the following: feeding intolerance, bloody stools, abdominal distension, thrombocytopenia, lethargy, color change, hyperglycemia, glycosuria, unexplained metabolic acidosis.
    Note: Subjects may be enrolled in the study on the basis of mycologic evidence higky suggestive of Candida sp. (eg. the growth of yeast in culture and/or the direct microscopic visualization of yeast, hyphae, or pseudohyphae) from a sample obtained from a normally sterile site (eg. blood and/or tissue). However, in these subjects, culture confirmation of Candida sp. must be obtained within 96 hours post treatment initiation.
    2. Male or female between the ages of 1 month and <18 years. Females of childbearing potential must have adequate contraception as determined by the Investigator for the duration of the trial.
    3. For each subject, parent or legal guardian must be willing and able to provide signed and dated written informed consent documentation. Assent from the child or adolescent will be obtained as appropriate. This is to be obtained prior to enrollment.
    4. Will be available for the duration of the study and be able to abide by the study restrictions.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Premature neonates born at gestation of less than 36 weeks (unless the sum of gestational age plus chronological age is at least 44 weeks).
    Note: Rounding to the closest week is round up one week if birth occurred on days 4 to 6 of the week and round down one week if birth occurred on days 1 to 3 of the week.
    2. Known history of intolerence, allergy, hypersensitivity or serious reaction to echinocandin antifungals.
    3. Female subjects who are pregnant or lactating, or planning a pregnancy during the course of the study.
    4. Subjects who have received more than 48 hours of systemic antifungal therapy for the Candida infection for which their enrollment is being considered.
    5. Subjects who have failed antifungal therapy with any systemic antifungal for this episode of candidiasis/candidemia. Recurrence within 2 weeks is considered failure of previous therapy.
    6. Subjects with any of the following abnormal laboratory values: Total bilirubin, AST or ALT >5 times the upper limit of normal (ULN).
    7. Subjects who require continued treatment with another systemic antifungal agent[oral nonabsorbable azoles (eg, clotrimazole troches) will be permitted]. Exception: the first 6 subjects enrolled who are between 1 month to <2 years of age may receive a second systemic antifungal agent at the investigator’s discretion.
    8. Subjects with poor venous access that would preclude IV drug delivery or multiple blood draws.
    9. Subjects who have participated in a study of an investigational drug or device
    (without any FDA and EMEA approved indications) within four weeks of study entry. The investigational use of licensed agents are permitted if the subject is on a stable regimen for four weeks prior to study start, and expected to remain on the stable regimen for the duration of the trial.
    10. Life expectancy <72 hours.
    11. Subjects with suspected Candida osteomyelitis, endocarditis, or meningitis.
    12. Subjects with a prosthetic device and/or vascullar catheter (including central veous catheter or an implantable port) at a suspected site of infection are to be excluded, unless the device is removed at study entryor soon after randomization (within 24-48 hours)
    Note: If it is anticipated that a prosthetic device or vascular catheter cannot be removed within this time frame, the medical monitor should be contacted to discuss enrolment.
    13. Subjects with a prosthetic heart valve or vascular graft suspected to be the site of the Candida infection and positive blood cultures.
    14. Other severe acute or chronic medical or psychiatric condition, electrocardiogram (ECG) abnormalities, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    • The primary endpoint will be an assessment of the safety and tolerability of anidulafungin.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F. of subjects incapable of giving consent
    Informed consent must be obtained by the parent or guardian. In the case where a child is able to provide informed assent, this must be obtained.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2008-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-14
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