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    Summary
    EudraCT Number:2019-000338-20
    Sponsor's Protocol Code Number:MK-7655A-021
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-18
    Trial results View 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 number2019-000338-20
    A.3Full title of the trial
    A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Bacterial Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label Active-control Pediatric Safety, Efficacy, PK Study of MK-7655A
    A.3.2Name or abbreviated title of the trial where available
    Open-label Active-control Pediatric Safety, Efficacy, PK Study of MK-7655A
    A.4.1Sponsor's protocol code numberMK-7655A-021
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/163/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme LLC
    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 supportMerck Sharp & Dohme LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme LLC
    B.5.2Functional name of contact pointHedy Teppler
    B.5.3 Address:
    B.5.3.1Street Address126 East Lincoln Avenue P.O. Box 2000
    B.5.3.2Town/ cityRahway, NJ
    B.5.3.3Post code07065
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267 305-7403
    B.5.6E-mailhedy_teppler@merck.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 Recarbrio
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNIMIPENEM
    D.3.9.1CAS number 64221-86-9
    D.3.9.4EV Substance CodeSUB08151MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCILASTATIN
    D.3.9.3Other descriptive nameCILASTATIN
    D.3.9.4EV Substance CodeSUB06264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRELEBACTAM
    D.3.9.2Current sponsor codeMK-7655
    D.3.9.4EV Substance CodeSUB184909
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.2.1.1.1Trade name Recarbrio
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Corp.
    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.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    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 INNIMIPENEM
    D.3.9.1CAS number 64221-86-9
    D.3.9.4EV Substance CodeSUB08151MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCILASTATIN
    D.3.9.3Other descriptive nameCILASTATIN
    D.3.9.4EV Substance CodeSUB06264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRELEBACTAM
    D.3.9.2Current sponsor codeMK-7655
    D.3.9.4EV Substance CodeSUB184909
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Treatment of bacterial infections in pediatric populations
    E.1.1.1Medical condition in easily understood language
    Bacterial infections in pediatric populations
    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 LLT
    E.1.2Classification code 10071097
    E.1.2Term Beta-lactam antibiotic resistance
    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
    To evaluate the safety and tolerability of IMI/REL (imipenem/cilastatin/relebactam) from the first dose of intravenous (IV) study intervention through 14 days after the end of therapy (EOT)
    E.2.2Secondary objectives of the trial
    A) To evaluate the efficacy of IMI/REL by assessing all-cause mortality at Day 28 post-randomization and clinical and microbiological response at the EOT, Early Follow-up (EFU, 7 to 14 days after EOT), and Late Follow-up (LFU, 7 to 14 days after EFU) visits
    B) To characterize the PK profile of imipenem and relebactam following administration of IMI/REL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Require hospitalization and treatment with IV antibacterial therapy for confirmed or suspected gram-negative bacterial infection (in the absence of meningitis), and is expected to require hospitalization through completion of IV study intervention, with at least 1 of the following primary infection types, based on the specific criteria required to be met for the respective infection type:
    - Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP)
    - Complicated intra-abdominal infection (cIAI)
    - Complicated urinary tract infection (cUTI)
    2. Participants is male or female and is from birth to less than 18 years of age inclusive, at the time of providing documented informed consent/assent. For Age Cohorts 4 and 5, participant is at least 37 weeks postmenstrual age at the time of providing documented informed consent/assent. Postmenstrual age is calculated by adding the gestational age at the time of birth to the chronological age at the time of providing documented informed consent/assent.
    3. Not be pregnant or breastfeeding, and at least 1 of the following conditions applies:
    a. Not be a woman of childbearing potential (WOCBP)
    OR
    b. A WOCBP must agree to follow the contraceptive guidance during the intervention period and for at least 24 hours after the last dose of study intervention
    4. The participant (or legally acceptable representative if applicable) has provided documented informed consent/assent for the study
    5. Have sufficient intravascular access to receive study intervention through an existing peripheral or central line
    E.4Principal exclusion criteria
    1. Is expected to survive less than 72 hours
    2. Has a concurrent infection that would interfere with evaluation of response to the study antibacterials (IMI/REL or Active Control)
    3. Has HABP/VABP caused by an obstructive process, including lung cancer (or other malignancy metastatic to the lungs resulting in pulmonary obstruction) or other known obstruction
    4. Has a cUTI that meets any of the following:
    - Complete obstruction of any portion of the urinary tract (ie, requiring a permanent indwelling urinary catheter or instrumentation)
    - Documented reflux of ileal loop urinary diversion
    - Suspected or confirmed perinephric or intrarenal abscess
    - Suspected or confirmed prostatitis, urethritis, or epididymitis
    - Trauma to pelvis/urinary tract
    - Presence of indwelling urinary catheter which cannot be removed at study entry
    5. Has any of the following medical conditions at screening:
    - A history of a seizure disorder (requiring ongoing treatment with anti-convulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years)
    - Cystic fibrosis
    6. Has a history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to IMI or to any of the following:
    - Any carbapenem, cephalosporin, penicillin, or other β-lactam agent
    - Other BLIs (eg, tazobactam, sulbactam, clavulanic acid, avibactam)
    7. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant’s participation for the full duration of the study
    8. If less than 3 months of age, has received more than 72 hours of empiric antibacterial treatment for suspected meningitis prior to initiation of IV study intervention
    9. If 3 months of age or older, or <3 months without suspected meningitis, has received potentially therapeutic antibacterial therapy (eg, with gram-negative activity), including bladder infusions with topical urinary antiseptics or antibacterial agents, for a duration of more than 24 hours during the 48 hours preceding the first dose of study intervention
    10. Is anticipated to be treated with any of the following medications:
    - Valproic acid or divalproex sodium (or has used valproic acid or divalproex sodium in the 2 weeks prior to screening) through 24 hours after completion of the final dose of IV study intervention for participants who receive IMI/REL or carbapenem
    - Concomitant IV, oral, or inhaled antimicrobial agents with gram-negative activity, in addition to those designated in the study intervention groups, during the course of all (IV/oral) study intervention
    - Planned receipt of suppressive/prophylactic antibiotics with gram-negative activity after completion of study intervention
    11. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to screening
    12. Has enrolled previously in the current study and been discontinued, or has received REL for any other reason
    13. Has an estimated CrCl (based on the Cockcroft-Gault equation, for participants ≥12 years of age) or estimated glomerular filtration rate (eGFR, based on the modified Schwartz equation, for participants <12 years of age) below that specified for the appropriate age range; or requires peritoneal dialysis, hemodialysis, or hemofiltration
    14. Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × upper limit of normal (ULN) at the time of screening
    15. Is, based on medical history at the time of providing documented informed consent/assent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
    16. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of participants with one or more adverse event (AE)
    2. Percentage of participants who discontinued study medication due to an AE
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 28 days
    2. Up to 14 days
    E.5.2Secondary end point(s)
    1. Number of deaths by all causes through Day 28
    2. Percentage of participants with a favorable clinical response at EOT
    3. Percentage of participants with a favorable clinical response at EFU
    4. Percentage of participants with a favorable clinical response at LFU
    5. Percentage of participants with a favorable microbiological response at EOT
    6. Percentage of participants with a favorable microbiological response at EFU
    7. Percentage of participants with a favorable microbiological response at LFU
    8. Area under the curve from time 0 to 24 hours (AUC0-24) of imipenem following administration of IMI/REL
    9. AUC0-24 of relebactam following administration of IMI/RE
    10. Concentration at end of infusion (Ceoi) of imipenem following administration of IMI/REL
    11. Ceoi of relabactam following administration of IMI/REL
    12 %T>MIC of imipenem (percentage of time imipenem concentration is above IMI/REL minimum inhibitory concentration) following administration of IMI/REL
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to Day 28
    2. Day 5 up to Day 14
    3. Day 12 up to Day 28
    4. Day 19 up to Day 42
    5. Day 5 up to Day 14
    6. Day 12 up to Day 28
    7. Day 19 up to Day 42
    8. Day 5 up to Day 14
    9. Day 5 up to Day 14
    10. Day 5 up to Day 14
    11. Day 5 up to Day 14
    12. Day 5 up to 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 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 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) Yes
    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 Yes
    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 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.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Colombia
    Philippines
    Ukraine
    Israel
    Mexico
    Russian Federation
    South Africa
    United States
    Türkiye
    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
    The overall study ends when the Sponsor receives the last
    laboratory test result or at the time of final contact with the last participant, whichever comes last.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 140
    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: 5
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 51
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 72
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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 Yes
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 140
    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 specified
    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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