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    Summary
    EudraCT Number:2014-001276-56
    Sponsor's Protocol Code Number:AIDA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-001276-56
    A.3Full title of the trial
    A prospective, open label, randomised controlled clinical trial, with pharmacokinetic-pharmacodynamic validation, to compare antimicrobial treatment with oral minocycline plus rifampicin to treatment with oral linezolid for complicated skin and skin structure infections (cSSSI) caused by Methicillin resistant Staphylococcus aureus (MRSA).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicentre, randomised controlled clinical trial to compare minocycline plus rifampicin with linezolid against MRSA in complex skin and skin structure infections (cSSSI).
    A.4.1Sponsor's protocol code numberAIDA
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNorth Bristol NHS - Southmead Hospital
    B.1.3.4CountryUnited Kingdom
    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 supportEuropean Commisssion
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMicron Research
    B.5.2Functional name of contact pointMicron Clinical
    B.5.3 Address:
    B.5.3.1Street AddressAlexander House, 38 Fore Hill
    B.5.3.2Town/ cityEly
    B.5.3.3Post codeCB7 4AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441353654524
    B.5.5Fax number+441353654501
    B.5.6E-mailclinical.mail@micron-research.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.2.5The 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 nameRifampicin
    D.3.2Product code Rifampicin
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIFAMPICIN
    D.3.9.1CAS number 13292-46-1
    D.3.9.2Current sponsor codeRifampicin
    D.3.9.3Other descriptive nameRifampicin
    D.3.9.4EV Substance CodeSUB10309MIG
    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.IMP: 2
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameminocycline
    D.3.2Product code minocycline
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMINOCYCLINE TABLETS BP 100mg
    D.3.9.1CAS number 10118-90-8
    D.3.9.2Current sponsor codeMinocycline
    D.3.9.3Other descriptive nameMINOCYCLINE
    D.3.9.4EV Substance CodeSUB08980MIG
    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.IMP: 3
    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 Zyvoxid
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameZyvoxid 600mg
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLinezolid
    D.3.9.3Other descriptive nameLINEZOLID
    D.3.9.4EV Substance CodeSUB08520MIG
    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
    Complicated Skin and Skin Structure infections caused by Methicillin Resistant Staphylococcus Aureus
    E.1.1.1Medical condition in easily understood language
    Complicated skin and skin structure infections (cSSSI). .
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    • demonstrate non inferiority between patients treated with minocycline plus rifampicin and those patients with gold standard therapy of linezolid in terms of clinical cure at Test of Cure.
    E.2.2Secondary objectives of the trial
    • assess the safety profile between the two treatment groups
    • assess microbiological eradication of MRSA from the site of infection between the treatment groups
    • assess the risk of emergence of resistance through sensitivity testing
    • demonstrate a relationship between drug exposure and outcome, including emergence of resistance, using state of the art pharmacokinetic-pharmacodynamic tools

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be enrolled in this study only if they meet all of the following numbered criteria:
    1. Hospitalised with clinical evidence of at least 1 of the following MRSA infections:
    • Ulcers
    • First or second degree burns of less than 20% of body surface area with concomitant signs of cellulitis (excluding third degree burns and burns >20% of body surface area)
    • Major abscess (see exclusion criteria for qualifications)
    • Deep or extensive cellulitis, and/or
    • Wounds – trauma or post surgical

    2. Presence of purulent or seropurulent drainage or at least 3 of the following signs and symptoms:
    • Drainage and/or discharge
    • Erythema (extending at least 1 cm beyond a wound edge)
    • Swelling and/or induration
    • Heat and/or localized warmth
    • 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 or a bacteraemia where a culture cannot be obtained from the site of infection

    5. Adult at least 18 years of age

    6. Written informed consent to participate in the study before any study-specific procedures are performed

    7. If of childbearing potential, must be using, or be prepared to use, a mechanical method of contraception (e.g. condom) during the study.
    8. If female, has a negative serum pregnancy test (serum beta-human Chorionic Gonadotropin (hCG)) result immediately prior to enrolment. 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 the serum test. The patient must end study medication therapy if the subsequent serum pregnancy test is positive

    Patients who have received an antibiotic for a cSSSI but have not responded and are considered a failure on that treatment regimen are eligible for this study provided they have a positive MRSA baseline culture.
    E.4Principal exclusion criteria
    Any of the following will exclude a patient from enrolment into the study.
    1. Women who are pregnant or breast-feeding

    2. Pre menopausal women who refuse to substitute oral contraception during treatment by contraception using mechanical means (e.g. condom)

    3. Known or suspected hypersensitivity to linezolid, minocycline or rifampicin

    4. Clinical or laboratory evidence of significant impairment of hepatic function, i.e. bilirubin of >3x upper limit of normal range, AST or ALT >5x upper limit of normal range, proven histological liver changes on biopsy

    5. Major abscess associated with diabetic foot conditions

    6. Suspected or confirmed osteomyelitis

    7. Treatment with other antimicrobials with activity against MRSA within 24hr prior to study inclusion. However, treatment failures from other therapy may be entered provided there is a positive baseline culture for MRSA.

    8. In the case of a mixed infection where it is considered necessary to concomitantly treat with a Gram-negative agent, this agent must have no activity against MRSA.

    9. Patients with a high probability of death within a week of study entry

    10. Haemodialysis patients or those requiring other means of renal support for end stage renal disease.
    E.5 End points
    E.5.1Primary end point(s)
    All signs and symptoms of cSSSI present at baseline have resolved and the patient did not receive new systemic or topical antibacterial treatment up to and including the Test of Cure Day 14
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 14
    E.5.2Secondary end point(s)
    Clinically relevant improvement of the local and systemic signs and symptoms of cSSSI present at baseline such that the patient would not meet study entry criteria and the patient did not receive new systemic or topical antibacterial treatment up to and including Test of Cure Day 14. Patients that received at least 4 days of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 14
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Linozolid
    E.8.2.4Number of treatment arms in the trial2
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    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 years2
    E.8.9.1In the Member State concerned months2
    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 months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 225
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 225
    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)
    patients will continue to receive treatment as deemed adequate by the Principal Investigator. The protocol follows standard of care procedures with the exclusion of the bloods samples for PK/PD analysis therefore once all visits are complete the patient will continue as normal.
    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 Decision2014-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
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