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    Summary
    EudraCT Number:2016-000656-99
    Sponsor's Protocol Code Number:REMPEX-507
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2023-09-28
    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 number2016-000656-99
    A.3Full title of the trial
    An Open label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of a Single Dose Infusion of VABOMERE® (Meropenem-Vaborbactam) in Pediatric Subjects From Birth to Less Than 18 Years of Age with
    Serious Bacterial Infections

    First EMA Decision Number of Paediatric Investigational Plan: P/0229/2015 obtained for meropenem (in combination with vaborbactam)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections
    A.3.2Name or abbreviated title of the trial where available
    TANGOKIDS
    A.4.1Sponsor's protocol code numberREMPEX-507
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02687906
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/229/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRempex Pharmaceuticals-Melinta 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 supportRempex Pharmaceuticals-Melinta 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 pointDirector of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address389 Interpace Parkway, Suite 450
    B.5.3.2Town/ cityParsippany, New Jersey
    B.5.3.3Post code 07054
    B.5.3.4CountryUnited States
    B.5.6E-mailrlazauskas@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 VABOMERE®; VABOREM®
    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 nameMeropenem + Vaborbactam
    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
    Suspected or confirmed negative bacterial infection
    E.1.1.1Medical condition in easily understood language
    Serious bacterial 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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10018657
    E.1.2Term Gram-negative bacterial infection NOS
    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 evaluate the pharmacokinetics (PK) of meropenem and vaborbactam following a single intravenous
    (IV) dose of Vabomere® (meropenem-vaborbactam) to pediatric subjects from birth to < 18 years for the purposes of dose-finding.
    To evaluate the safety and tolerability of a single IV dose of Vabomere (meropenem-vaborbactam) to
    pediatric subjects from birth to < 18 years for the purposes of dose-finding.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A signed and dated written informed consent (ICF) from the parent or legal representative and a subject assent (according to local IRB,requirements);
    2. Male or female from birth to < 18 years of age;
    3. Are hospitalized, in stable condition, and receiving systemic antibiotics for a known or suspected bacterial infection; or subjects receiving peri-operative prophylactic use of antibiotics;
    4. The subject will be observed in the hospital for at least 6 hours after the study drug is administered;
    5. If female and has reached menarche, or has reached Tanner Stage 3 breast development (even if not having reached menarche), the subject is practicing appropriate birth control or is sexually abstinent;
    6. Sufficient intravascular access (peripheral or central) to receive study drug.
    E.4Principal exclusion criteria
    1. Signs of severe sepsis;
    2. 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;
    3. 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;
    4. Female adolescent subjects who are pregnant or breastfeeding or have a positive serum β-human chorionic gonadotropin (hCG) pregnancy test at screening and at pre-dose Day 1;
    5. Males who are unwilling to practice abstinence or use an acceptablemmethod of birth control during the entire study period (i.e. condom with spermicide);
    6. Renal function at screening as estimated by creatinine clearance < 50 mL/min/1.73 m2 as calculated using the updated Schwartz bedside formula;
    7. Treatment within 30 days prior to enrollment with valproic acid;
    8. Treatment within 30 days prior to enrollment with probenecid;
    9. Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy;
    10. Neutropenia with absolute neutrophil count (ANC) < 500 cells/mm3;
    11. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3X ULN or total bilirubin ≥ 1.5X ULN;
    12. Receipt of any investigational medication or investigational device within 30 days prior to enrollment;
    13. Previous exposure to vaborbactam or Vabomere;
    14. Use of meropenem within 48 hours of administration of study drug or 12 hours after study drug
    administration;
    15. Known significant hypersensitivity to any beta-lactam antibiotic;
    16. Unable or unwilling in the judgment of the Investigator, to comply with the protocol;
    17. Subject is a child of an employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or the Investigator;
    18. Body mass index (BMI) outside the range (below the 5th percentile or above the 95th percentile) for height, age and weight except for children < 2 years of age.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic parameters of meropenem and vaborbactam (Cmax, AUC, t1/2, Vz, Vss, and CL).

    Safety of a single IV dose of Vabomere (meropenem-vaborbactam) assessed according to clinical
    laboratory parameters, and adverse events (AEs), serious adverse events (SAEs), vital signs and
    electrocardiogram (ECG) up to 7 days following termination of the study drug infusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples will be taken for pharmacokinetic (PK) analysis using sparse pharmacokinetic sampling on Day 1. Time of blood sample collection: pre-dose and at 3, 4 and 6 hours after the start of the infusion.

    Adverse events and clinical laboratory parameters, vital signs and ECG to be assessed from the time of the consent is signed through Day 7 follow up post-study treatment administration.
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    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 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 No
    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
    End of Trial is defined as the last visit at the Day 7 Follow-up of the last subject in the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years7
    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: 67
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 16
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 16
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 8
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 27
    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 from the parent or legal representative (and assent in subjects 8 years of age or older) will be obtained before the initiation of any study-specific procedures.
    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 67
    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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