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    Summary
    EudraCT Number:2013-005415-26
    Sponsor's Protocol Code Number:TMC-ORI-11-01
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-03-19
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2013-005415-26
    A.3Full title of the trial
    An Open label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of Oritavancin Single Dose Infusion in Pediatric Subjects Less Than 18 Years of Age with Suspected or Confirmed Bacterial Infections
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the pharmacokinetics, safety and tolerability of oritavancin in children less than 18 years old with a bacterial infection.
    A.3.2Name or abbreviated title of the trial where available
    ORKIDS
    A.4.1Sponsor's protocol code numberTMC-ORI-11-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02134301
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/056/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMelinta Therapeutics
    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 supportMelinta Therapeutics
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportMenarini I.F.R.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMelinta Therapeutics
    B.5.2Functional name of contact pointSenior Director, Alliance Manag.
    B.5.3 Address:
    B.5.3.1Street Address44 Whippany Road, Suite 280
    B.5.3.2Town/ cityMorristown
    B.5.3.3Post codeNJ 07960
    B.5.3.4CountryUnited States
    B.5.6E-maildbaran@melinta.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 Orbactiv
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxemburg S.A.(MIOL)
    D.2.1.2Country which granted the Marketing AuthorisationLuxembourg
    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 nameOritavancin
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Gram positive bacterial infection
    E.1.1.1Medical condition in easily understood language
    Bacterial infections
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10053021
    E.1.2Term Gram-positive bacterial infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10004047
    E.1.2Term Bacterial infections NEC
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10060945
    E.1.2Term Bacterial infection
    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
    The primary objective is the evaluation of pharmacokinetic profile (AUC and Cmax) after a single oritavancin infusion in pediatric subjects.
    E.2.2Secondary objectives of the trial
    1. The evaluation of pharmacokinetic profile (half-life [t1/2], tmax, volume of distribution [Vz], and CL) after a single oritavancin infusion in pediatric subjects.

    2. Safety and tolerability assessments will be evaluated up to 60 days following the oritavancin infusion.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females <18 years of age
    2. Neonates must be at least 34 weeks post-conception age
    3. Written informed consent before initiation of any study-related procedures. Parent or legal guardian has given informed consent, as appropriate; and pediatric subject has given verbal assent where appropriate.
    4. Suspected or confirmed Gram positive bacterial infection receiving antibiotic therapy
    5. Intravenous access to administer study drug
    6. In the investigator’s opinion, the subject will require hospitalization for at least 24 hours after the study drug is administered.
    E.4Principal exclusion criteria
    1. Septic shock or acute haemodynamic instability.
    2. History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, or teicoplanin) or any of their excipients.
    3. Currently using vancomycin or other glycopeptides
    4. Females who are of childbearing potential and unwilling to practice abstinence or use at least two methods of contraception (oral contraceptives, barrier methods, approved contraceptive implant) during the entire study period.
    5. Female subjects of childbearing potential who are lactating or who have a positive pregnancy test result at screening coordinator, other staff or relative thereof directly involved in the conduct of the study.
    6. Males who are unwilling to practice abstinence or use an acceptable method of birth control during the entire study period (i.e. condom with spermicide).
    7. Any surgical or medical condition which, in the opinion of the investigator, would put the subject at increased risk or is likely to interfere with study procedures or PK of the study drug.
    8. Subjects whom the investigator considers unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study (eg, unlikely to survive 60 days from initiation of study drug or unlikely to return for the Day 14 follow-up visit).
    9. Treatment with investigational medicinal product or investigational device within 30 days (or 5 times the half-life of the investigational medicine, whichever is longer) before enrollment and for the duration of the study.
    10. Subjects who are taking heparin or warfarin and/or require anticoagulant monitoring (aPTT, PT, INR).
    11. Subjects with AST or ALT > 3xULN or total bilirubin ≥ 2 ULN.
    12. Neutropenia with absolute neutrophil count (ANC) <500 cells/mm3.
    13. Any clinically significant disease or condition affecting a major organ system, including but not limited to gastrointestinal, renal, hepatic, endocrinologic, broncho-pulmonary, neurological, metabolic or cardiovascular disease.
    14. Currently receiving cytotoxic chemotherapy or immunosuppressive therapy with tacrolimus or cyclosporine
    15. Previous participation in this study
    16. Subject is the child of the investigator or his/her deputy, research assistant, pharmacist, study
    E.5 End points
    E.5.1Primary end point(s)
    PK parameters (Cmax and area under the plasma concentration-time curve [AUC])
    E.5.1.1Timepoint(s) of evaluation of this end point
    On Day 1, subjects will receive oritavancin and four PK samples will be collected over 24 hours. An additional three PK samples will be collected 48, 72, 336 hours after the infusion start time (total number of samples = 7).
    E.5.2Secondary end point(s)
    1. PK parameters (half-life [t1/2], tmax, volume of distribution [Vz], and CL).

    2. Safety of an oritavancin infusion assessed according to clinical laboratory parameters, and adverse events (AEs), serious adverse events (SAEs), vital signs and ECG up to 60 days following termination of the study drug infusion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    On Day 1, subjects will receive oritavancin and four PK samples will be collected over 24 hours. An additional three PK samples will be collected 48, 72, 336 hours after the infusion start time (total number of samples = 7).

    Safety and tolerability will be assessed by physical examination, 12-lead ECG, vital signs, safety labs (hematology and chemistry). Cerebral spinal fluid will also be collected for subjects in the age cohort of 0-28 days to assess oritavancin levels (only if collected as part of the subject’s routine medical care).

    Subjects/Caregivers will also be contacted by phone at Day 60 to collect any adverse events/serious adverse events that may occur between Day 14 and Day 60.
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First administration to paediatric patients
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    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
    Last visit of the last subject (LVLS), which is the day 60 (+7 days) safety follow-up telephone call
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 48
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 8
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 16
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 16
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    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 No
    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
    Written informed consent will be obtained from all subjects (or their guardian or legally authorized representative), and whenever possible, verbal assent will be obtained from children greater than 8 years of age.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 48
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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