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    Summary
    EudraCT Number:2008-004150-32
    Sponsor's Protocol Code Number:A8851008
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-03
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-004150-32
    A.3Full title of the trial
    A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study To Assess The Safety, Pharmacokinetics, And Evaluate The Response To Anidulafungin When Treating Children With Invasive Candidiasis.
    A.4.1Sponsor's protocol code numberA8851008
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00761267
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/091/2015
    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 organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    B.5.5Fax number13037391119
    B.5.6E-mailClinicalTrials.govCallCentre@pfizer.com
    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.2.1.1.1Trade name ECALTA ®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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 solution for infusion
    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 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) 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
    INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA
    E.1.1.1Medical condition in easily understood language
    Fungal infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10064954
    E.1.2Term Invasive candidiasis
    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
    • 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 pharmacokinetic parameters of polysorbate 80 following IV infusion of anidulafungin (area under curve over dosing interval (AUC24) and peak concentration (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 No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriate qualified member of the investigator’s study team before subjects are included in the study.
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Subjects must be either (1) at high risk for candidiasis or (2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC), as defined below:
    a. At high risk for candidiasis (subjects 1 month to <2 years of age only):
    Subjects is at high risk for candidiasis and antifungal therapy with aidulafungin for a minimum of 5 days is considered appropriate by the investigator.

    --OR—

    b. Definitive diagnosis of invasive candidiasis/candidemia (ICC) (all age groups) is based on the growth of Candida sp. from a blood and/or tissue culture obtained from a normally sterile site.
    For the purpose of study entry, a subject enrolled with definitive diagnosis of ICC must have at least one microbiologic AND at least one clinical criterion listed below.

    Microbiologic Criteria:
    Subject must have at least one of the criteria listed below either at the time of study entry or within 96 hours prior to study entry.
    • 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 (other than blood), with or without a positive blood culture;
    • Positive culture for Candida sp. from a percutaneous drain (eg, chest tube, intra-abdominal) placed <24 hours in a normally sterile site;
    • Positive blood culture for Candida sp. plus ophthalmic examination consistent with Candida endophthalmitis;
    • Candida endocarditis: (not applicable to Korean and Portuguese investigator sites): At least one positive blood culture for Candida sp. and evidence of endocarditis on echocardiogram;
    • Candida osteomyelitis: (not applicable to Korean and Portuguese investigator sites): At least one positive culture for Candida sp. from a bone biopsy or aspirate and evidence of osteomyelitis on a magnetic resonance imaging (MRI) study;

    Clinical Criteria:
    Subject must have at least one of the criteria listed below either at the time of study entry or within 96 hours prior to study entry.
    • Fever, defined as an oral/tympanic temperature ≥100.4°F (38.0oC), rectal temperature ≥101.4oF (38.6oC) or an axillary temperature ≥99.4oF (37.4oC);
    • Hypothermia, defined as a temperature less than 96.8°F (36.0oC);
    • Hypotension, defined as 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);7
    • Other 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.
    ** Important Notes **
    Subjects may be enrolled in the study and initiate treatment on the basis of mycologic evidence highly 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). If culture confirmation of Candida sp.is not obtained subjects may remain in the study and receive sstudy treatment at the discretion of the investigator. Should the investigator choose to withdraw the subject from study treatment, the subject will discontinue treatment but will remain in the study for continued safety monitoring for up to 6 weeks after the last dose of study treatment. Refer to Section 6.5 and Section 6.6 for follow up visit requirements.
    Positive cultures for Candida sp. from urine (in the absence of clinical signs and symptoms of pyelonephritis), sputum, bronchoalveolar lavage (BAL), endotracheal aspiration, gastric drainage or gastric aspiration do not qualify as a positive culture for definitive diagnosis of ICC.
    2. Male or female between the ages of 1 month and <18 years.
    3. Male and female subjects of childbearing potential must agree to use a highly
    effective method of contraception throughout the treatment period and up to the
    6 week follow-up visit. A subject is of childbearing potential if, in the opinion of the
    investigator, he/she is biologically capable of having children and is sexually active.
    4. 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.
    5.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.Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    2.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.
    3.Known history of intolerance, allergy, hypersensitivity or serious reaction to anidulafungin or any of its excipients (including fructose), or to other echinocandin antifungals.
    4. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception during the treatment period and up to the 6 week follow-up visit.
    5. Subjects who have failed antifungal therapy with any systemic echinocandin 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 meningitis. (For Korean and Portuguese investigator sites only: Subjects with suspected Candida endocarditis and Candida osteomyelitis are also excluded.)
    12.Subjects with a prosthetic device and/or vascular catheter (including central venous catheter or an implantable port) at a suspected site of infection are to be excluded, unless the device is removed or in situations where catheter salvage is desirable due to the subject’s clinical condition.
    ** Important Note ** - If it is anticipated that a prosthetic device or vascular catheter cannot be removed, the medical monitor should be contacted to discuss enrolment.
    13.Subjects with a vascular graft suspected to be the site of the Candida infection and positive blood cultures.
    14.Subjects with prosthetic or native valve Candida endocarditis who have not and/or cannot undergo valvular replacement surgery prior to or soon after study entry. (Not applicable to Korean and Portuguese investigator sites.)
    15.Subjects with Candida osteomyelitis associated with a prosthetic device in whom the prosthetic device has not been and/or cannot be removed surgically prior to or soon after study entry. (Not applicable to Korean and Portuguese investigator sites.)
    16.Other severe acute or chronic medical or psychiatric condition, electrocardiogram (ECG) abnormalities, or laboratory abnormality that may increase the risk associated with study anticipation 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.5.1.1Timepoint(s) of evaluation of this end point
    End of Intravenous Therapy.
    E.5.2Secondary end point(s)
    • Global response (based on the clinical and microbiological responses) at the EOIVT, EOT, Week 2 and Week 6 FU visits;
    • Pharmacokinetic parameters of anidulafungin in children aged 1 month to <2 years following IV infusion of anidulafungin: AUC24 and Cmax;
    • Pharmacokinetic parameters of polysorbate 80 following infusion of anidulafungin: AUC24 and Cmax;
    • Exposure-response (efficacy and safety endpoints) relationships of anidulafungin using a nonlinear mixed effects approach as appropriate;
    • Rates of relapse (recurrence) at the Week 2 and Week 6 FU visits;
    • Rates of new infection at the Week 2 and Week 6 FU visits;
    • All-cause mortality during study therapy and Follow-Up visits.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Therapy if switch to oral treatment.
    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
    tolerability
    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) 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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Greece
    Italy
    Russian Federation
    United Kingdom
    United States
    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
    As Per Protocol
    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 months6
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 70
    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.1.1.4.1Number of subjects for this age range: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 10
    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.3.3.6.1Details 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 19
    F.4.2.2In the whole clinical trial 70
    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)
    As per protocol
    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 Decision2016-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-14
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