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    Summary
    EudraCT Number:2005-003194-24
    Sponsor's Protocol Code Number:CPI-226-03
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-003194-24
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Evaluation Committee-Blinded Study to Assess the Efficacy of Topical Administration of Omiganan 1.0% Gel in Preventing Local Catheter Site Infections and Catheter Colonization in Patients Undergoing Central Venous Catheterization
    A.4.1Sponsor's protocol code numberCPI-226-03
    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 SponsorCadence Pharmaceuticals, Inc.
    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 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 No
    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 nameOmiganan 1.0% Gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCPI-226 1%
    D.3.9.3Other descriptive nameMBI-226 1% Gel; ILRWPWWPWRRK-amide
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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) 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 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.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 Betadine Solution
    D.2.1.1.2Name of the Marketing Authorisation holderPurdue Product L.P.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namePovidone iodine solution 10%
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPovidone Iodine
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.0
    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) 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 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
    Prevention of local site infections in patients requiring central venous and/or arterial catheterization and/or peripherally inserted central venous catheterization (PICC).
    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
    Primary objectives:

    1. To demonstrate the effectiveness of omiganan 1.0% gel compared to 10% povidone-iodine in preventing local catheter site infections (LCSI) in patients requiring at least one central venous catheter. LCSI will be determined by a blinded Evaluation Committee (EC). The primary efficacy endpoint is the incidence of LCSI prior to study discharge (at early termination, removal of the final study catheter, or study Day 28) among survivors in the modified intent-to-treat (MITT) analysis set.

    2. To obtain additional safety data for omiganan 1.0% gel.
    E.2.2Secondary objectives of the trial
    All secondary efficacy endpoints will be determined by the blinded EC. Secondary efficacy endpoints will be analyzed using the MITT analysis set unless otherwise noted. Comparisons between treatment groups of the following incidences will be made as secondary efficacy endpoint analyses:
    - clinically diagnosed LCSI or death
    - clinically diagnosed LCSI in the intent-to-treat (ITT) analysis set
    - microbiologically-confirmed LCSI
    - catheter-related bloodstream infections (CRBSI)
    - bloodstream infections (BSI)
    - catheter colonization

    LCSI, CRBSI, BSI and catheter colonization will be tabulated by pathogen and by total catheter days. All primary and secondary endpoints will additionally be analyzed in the per protocol analysis set making the same comparisons as described for the MITT set.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All of the following criteria must be met for a patient to be eligible for the study:

    1. New insertion of at least 1 noncuffed (nontunneled) temporary central venous catheter within 4 hours of randomization and for which the insertion site was disinfected using 10% povidone iodine for a minimum of 2 minutes prior to catheter placement. If a PICC and/or arterial catheter are placed within 30 minutes prior to the insertion of the first study CVC, they can also be considered study catheters assuming their insertion sites were prepared with povidone-iodine. PICC and arterial lines placed within 30 minutes prior to the insertion of the first study CVC should not be designated as study catheters until after the study CVC has been inserted.

    2. Pre-existing non-study CVC, PICC and/or arterial catheters in place at the time of the first study CVC placement must be removed within 8 hours of their respective insertion(s).

    3. Males and females of at least 13 years of age.

    4. A negative urine or serum pregnancy test at baseline in women of child bearing potential.

    5. Able to provide signed informed consent. If less than 18 years of age, written consent from both the patient and a legal guardian must be obtained.
    E.4Principal exclusion criteria
    Patients are excluded from the study if any of the following are met:

    1. CVC (proposed study catheter) in place for greater than 4 hours of randomization.

    2. Insertion of, or requirement for, any study catheter impregnated/bonded with an antimicrobial substance.

    3. High probability of death within 14 days of enrollment as assessed by the Investigator.

    4. Prior treatment with vancomycin (intravenous administration only), daptomycin, linezolid, or quinupristin/dalfopristin within 48 hours of first study catheter insertion or prior treatment with Tigecycline within one week of first study catheter insertion.

    5. Requirement for topical antibiotic use within 10 cm of any study catheterization site.

    6. Known severe neutropenia (ANC <500 mm3) or recent administration of antineoplastic therapy expected to result in severe neutropenia within 48 hours of first study catheter insertion.

    7. Routine non-complicated coronary artery bypass grafting (CABG) patients, bone marrow transplant (BMT) or solid organ transplant (SOT) patients.

    8. Patients who have been treated with any investigational drug within the previous 30 days.

    9. Patients who are participating in an investigational drug study at any time during the course of this study.

    10. Patients anticipated to be catheterized for less than 48 hours.

    11. Patients who have a suspected or known bloodstream infection at enrollment.

    12. Burn patients or patients with toxic epidermal necrolysis.

    13. History of sensitivity to any ingredients in the study drugs.

    14. Known allergy to adhesive tape or adhesive bandages.

    15. Any evidence or history of illicit intravenous drug use within 4 weeks prior to the study, unless a transesophageal ultrasound has ruled out infective endocarditis

    16. A medical condition that the Investigator believes may interfere with the safety of the patient or the intent and conduct of the study (such as severe eczema, psoriasis and/or dermal infections that would interfere with assessment of study endpoints).

    17. Pregnant , lactating or breastfeeding women.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of LCSI prior to study discharge (early termination, removal of last catheter, or study Day 28) among survivors in the MITT analysis set. The hypotheses being tested are:
    H1 - Among surviving patients, the incidence of clinically diagnosed LCSI is lower in the omiganan group than in the control group.
    H2 - There is no difference between the omiganan group an the control group in the incidence of clinically diagnosed LCSI in surviving patients.
    The presence or absence of clinically diagnosed LCSI will be determined by a blinded EC according to predertermined standards. Patients will be judged to be either a success (free of LCSI), failure (LCSI), or indeterminate (LCSI cannot be ruled out). Indeterminate or missing outcomes will be analyzed as treatment failures. The EC will take into account scores of erythema and edema (assessed and graded using a 2-part modified Draize scale) and purulence (assessed using a quantitative scoring system); the presence or absence of an abnormally warm temperature; the presence or absence of pain/tenderness at the insertion site; and the results of microbiological cultures. Patients who die during the study period will be excluded from this analysis.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 No
    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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Evaluation-committee blinded
    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.8.4.1Number 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 EEA23
    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 No
    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
    Trial duration is 28 days or when the last study catheter is removed.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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) No
    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 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If a patient is unable to provide written informed consent, a legally acceptable representative must provide signed informed consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state61
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1056
    F.4.2.2In the whole clinical trial 1850
    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 Decision2007-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-25
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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