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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2005-001548-21
    Sponsor's Protocol Code Number:ICLA-08-CSI1
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-06-21
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLatvia - SAM
    A.2EudraCT number2005-001548-21
    A.3Full title of the trial
    Phase 3, Randomized, Investigator-Blind, Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim versus Intravenous Linezolid in Complicated Skin and Skin Structure Infections
    A.3.2Name or abbreviated title of the trial where available
    ASSIST-1
    A.4.1Sponsor's protocol code numberICLA-08-CSI1
    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 SponsorArpida AG
    B.1.3.4CountrySwitzerland
    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 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIclaprim
    D.3.2Product code AR-100 (base) AR-100.001 (mesilate)
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNiclaprim
    D.3.9.2Current sponsor code192314-93-5
    D.3.9.3Other descriptive name5-[(2RS)-2-cyclopropyl-7,8-dymethoxy-2H-chromen-5-ylmethyl pyrimidine-2,4-diamine methanesulfonate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.8 (free base)
    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.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 Information not present in EudraCT
    D.2.1.1.1Trade name Zyvox®
    D.2.1.1.2Name of the Marketing Authorisation holder1. Pharmacia and Upjohn Company ASV 2. Fresenius Kabi AS, Halden, Norway
    D.2.1.2Country which granted the Marketing AuthorisationLatvia
    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 nameZyvox®
    D.3.4Pharmaceutical form Solution for infusion
    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 INNLinezolid
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Complicated skin and skin structure infections are predominantly caused by the following Gram-positive pathogens: Staphylococcus aureus, including methicillin-resistant strains, beta hemolytic streptococci (most commonly S. pyogenes and S. agalactiae), enterococcus spp., and viridans group streptococci.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level HLT
    E.1.2Classification code 10040786
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure visit (7 to 14 days after the end of treatment).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to compare iclaprim with linezolid regarding:
    1.Clinical efficacy at the end of study medication treatment;
    2.Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infections;
    3.Clinical outcome in the microbiology evaluable population;
    4.Bacteriologic outcome in the microbiology evaluable population;
    5.Bacteriologic eradication rates of baseline pathogens;
    6.Clinical outcome in the modified intent-to-treat population;
    7.Bacteriologic outcome in the modified intent-to-treat population;
    8.Baseline in vitro susceptibility of isolated pathogens in the microbiology evaluable population;
    9.Safety and tolerability of iclaprim treatment;
    10.To obtain population pharmacokinetic data for patients who received iclaprim.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Hospitalized with clinical evidence of at least 1 of the following:
    a.Infected ulcers,
    b.First or second degree burns of less than 20% of body surface area with concomitant signs of cellulites (excluding third degree burns and burns >20% of body surface area),
    c.Major abscess,
    d.Deep or extensive cellulites, and/or
    e.Wound infections.
    2.Presence of purulent or seropurulent drainage or at least 3 of the following signs and symptoms:
    a.Drainage and/or discharge,
    b.Erythema (extending at least 1 cm beyond a wound edge),
    c.Swelling and/or induration,
    d.Heat and/or localized warmth, and/or
    e.Pain and/or tenderness to palpation.
    3.At least 1 of the following conditions considered to be pathogen-related:
    -Fever (temperature >38°C/100.4°F orally, rectally, or tympanically),
    -Elevated total peripheral white blood cells (WBCs) >10,000/mm3, or
    ->15% immature neutrophils (bands), regardless of total peripheral WBC count.
    4.Accessible infection site for culture;
    5.At least 18 years of age.
    6.Written informed consent to participate in the study before any study-specific screening procedures are performed. If any patient is unable to give consent, it may be obtained from the patient’s next of kin or legally acceptable representative in accordance with local laws and legislation.
    7.If female, must either:
    7a. be post-menopausal for at least 1 year,
    7b. have had a hysterectomy of tubal ligation
    7c. if of childbearing potential have maintained her normal menstrual pattern for the 3 months prior to study entry, and have taken hormonal contraceptives for at least 1 month prior to study entry;
    7d. if of childbearing potential agree to use spermicide and barrier methods;
    7e. if of childbearing potential be using another medically acceptable method of contraception and agrees to continue with the same method during the study;has a negative serum pregnancy test (serum beta-human chorionic gonadotropin [hCG] result immediately prior to enrollment. If obtaining the serum pregnancy result would cause a delay in treatment, the patient can be entered on the basis of a negative urine pregnancy test result. The urine pregnancy test must be sensitive to at least 50 mU/mL of beta-hCG, pending results of serum test. The patient must end study medication therapy if the serum pregnancy test is positive
    E.4Principal exclusion criteria
    1.Complicated skin and skin structure infections of the following categories:
    a.Severely impaired arterial blood supply such as that amputation of the infected anatomical site is likely,
    b.Infected diabetic foot ulcers or decubitus ulcers,
    c.Infected human or animal bites,
    d.Necrotizing fasciitis or gangrene,
    e.Uncomplicated skin or skin structure infection,
    f.Self-limiting infections such as isolated folliculitis or other infection that has a high surgical incision cure rate or furunculosis or carbunculosis that is not associated with a cellulitis at least 1 cm in radius,
    g.Skin and/or skin structure infection that can be treated by surgery alone,
    h.Infections associated with a prosthetic device, and
    i.Suspected or confirmed osteomyelitis.
    2.Known or suspected concurrent infection or conditions requiring systemic anti-infective treatment, prophylaxis, or suppression therapy (excluding ongoing suppression therapy for herpes simplex virus);
    3.Known or suspected human immunodeficiency virus (HIV)-infected patients with cluster of differentiation (CD4) count <350 cells/mm3 recorded in the last 30 to 60 days, or receiving highly active anti-retroviral therapy;
    4.Absolute neutrophil count Ј1000 cells/mm3;
    5.Organ transplant patients having received a transplant within the last 6 months;
    6.Received >24 hours’ coverage of Gram positive pathogens by any systemic antibiotic or any topical antibiotic at the infection site within the last 7 days, unless there is evidence of treatment failure or documented resistance of Gram-positive pathogens to the previous antibiotic therapy;
    7.Complicated skin and skin structure infections suspected or documented as being due exclusively to Gram-negative or anaerobic organisms based on epidemiological grounds or on direct examination of a specimen with Gram’s stain (mixed complicated skin and skin structure infections in which both Gram-positive and Gram-negative pathogens are isolated may be enrolled if the clinician suspects that the predominant causative pathogen is a Gram-positive organism);
    8.Infections due to a Gram-positive organism known to be resistant to linezolid and/or mixed complicated skin and skin structure infections in which the Gram-negative organisms are known to be resistant to aztreonam;
    9.Complicated skin and skin structure infections known or suspected to be a fungal, parasitic or viral infection;
    10.Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 30 days of study entry;
    11.Known or suspected local or systemic hypersensitivity to trimethoprim, linezolid, or related compounds;
    12.Morbid obesity defined as a body mass index >40 or weight >150 kg;
    13.Pregnant or lactating female;
    14.Severe renal impairment with CrCL <30mL/min;
    15.Severe hepatic disease (Child-Pugh Class C) or known lanine transaminase >5 times the upper limit of normal and/or bilirubin >1.5 times the upper limit of normal;
    16.Requirements for steroids >10 mg/day, prednisolone or equivalent, or received steroids >10 mg/day prednisolone or equivalent in the past 3 days;
    17.Cardiovascular conditions and treatments:
    a.Patients known to have congenital or sporadic syndromes of QTc prolongation,
    b.Type IA or III anti-arrhythmic drugs,
    c.Non-sustained ventricular tachycardia defined as ≥10 consecutive ventricular beats at a rate of >120 beats per minute with a duration of <30 seconds,
    d.Bradycardia (<50 beats per minute), and
    e.QT/QTc interval outside the normal range defined as: QTc>470 ms (Stage A only).
    18.Abnormal blood electrolyte levels (potassium, magnesium) that cannot be corrected prior to study inclusion;
    19.Previous enrollment in any iclaprim study;
    20.Receipt of any investigational agent or device within 30 days of study medication administration; or
    21.Patients unable or unwilling to adhere to the study-designated procedures and restrictions.
    Exclusion criteria related to use of linezolid:
    22.Patients with pheochromocytoma, carcinoid syndrome, or uncontrolled hypertension or
    23.Patients with hyperthyroidism.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is clinical cure rate based on all patients in the Per Protocol and Intent-to-Treat populations at the test of cure visit.Safety endpoints are changes from baseline in adverse events, serious adverse events, hematology, clinical chemistry, and urine test results, vital signs, physical examinations and EGG tests.
    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 Yes
    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 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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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.8.3 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.8.5The 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 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 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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 2005-06-21. 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 500
    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 Decision2005-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-08-21
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