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MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)

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ClinicalTrials.gov Identifier: NCT03230838
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.

Condition or disease Intervention/treatment Phase
Complicated Urinary Tract Infection Pyelonephritis Drug: Ceftolozane Drug: Tazobactam Drug: Meropenem Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Versus Meropenem in Pediatric Subjects With Complicated Urinary Tract Infection, Including Pyelonephritis
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : September 6, 2020
Estimated Study Completion Date : September 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ceftolozane/Tazobactam
Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum ceftolozane 1 g/dose and tazobactam 0.5 g/dose) administered intravenously (IV) every 8 hours. After receiving at least 9 doses of IV study treatment, participants may be switched to open-label, standard-of-care oral step-down antibiotic therapy at the investigator's discretion. Total antibiotic duration (IV only or IV + oral) is a minimum of 7 days and a maximum of 14 days.
Drug: Ceftolozane
Ceftolozane 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days

Drug: Tazobactam
Tazobactam 10 mg/kg (maximum 0.5 g/dose) administered IV every 8 hours for between 7 to 14 days

Active Comparator: Meropenem
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours. After receiving at least 9 doses of IV study treatment, participants may be switched to open-label, standard-of-care oral step-down antibiotic therapy at the investigator's discretion. Total antibiotic duration (IV only or IV + oral) is a minimum of 7 days and a maximum of 14 days.
Drug: Meropenem
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days.
Other Name: MERREM®




Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to Day 49 ]
    Number of participants with one or more AEs

  2. Discontinuations [ Time Frame: Up to Day 14 ]
    Number of participants who discontinued study drug due to an AE


Secondary Outcome Measures :
  1. Clinical response of cure [ Time Frame: Up to Test of Cure Visit (up to 23 days) ]
    Percentage of participants who have a clinical response of cure

  2. Microbiological eradication of all baseline pathogens [ Time Frame: Up to Test of Cure Visit (up to 23 days) ]
    Percentage of participants who have microbiological eradication or presumed eradication of all baseline pathogens.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a legal representative who provides written informed consent on the participant's behalf and provides age-appropriate written informed assent (as applicable) for the trial.
  • Ages from birth (defined as >32 weeks gestational age and ≥7 days postnatal) to <18 years of age.
  • Requires IV antibacterial therapy for the treatment of cUTI.
  • Have a pretreatment baseline urine culture specimen obtained within 48 hours before the start of administration of the first dose of study treatment and preferably prior to administration of any potentially therapeutic antibiotics.
  • Has pyuria.
  • Has clinical signs and/or symptoms of cUTI at the Screening Visit.
  • Is not of reproductive potential; but if of reproductive potential agrees to avoid becoming pregnant or impregnating a partner during screening, while receiving study treatment and for at least 30 days after the last dose of study treatment.
  • Female of reproductive potential is not pregnant, and not planning to become pregnant within 30 days of the last day of treatment administration; and is nonlactating.

Exclusion Criteria:

  • Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days prior to the first dose of study treatment in this current trial.
  • Has previously participated in any trial of ceftolozane or ceftolozane/tazobactam or has enrolled previously in the current trial and been discontinued.
  • Has a history of any moderate or severe hypersensitivity (eg, anaphylaxis), allergic reaction, or other contraindication to any of the following: β-lactam antibiotics (eg, penicillins, cephalosporins, and carbapenems), β-lactamase inhibitors (eg, tazobactam, sulbactam, clavulanic acid, avibactam), or metronidazole.
  • Has a history of a cUTI within the past 1 year prior to randomization known to be caused by a pathogen resistant to either IV study treatment.
  • Has a concomitant infection at the time of randomization that requires nonstudy systemic antibacterial therapy in addition to IV study treatment or oral step -down therapy.
  • Has received potentially therapeutic antibacterial therapy for a duration more than 24 hours during the 48 hours preceding the first dose of study treatment.
  • Has any of the following: a) intractable UTI or pyelonephritis infection at baseline that the Investigator anticipates would require more than 14 days of study treatment; b) confirmed fungal urinary tract infection at time of randomization; c) permanent indwelling bladder catheter or instrumentation including nephrostomy; d) current urinary catheter that is not scheduled to be removed before the end of all study treatment; e) complete, permanent obstruction of the urinary tract; f) suspected or confirmed perinephric or intrarenal abscess; g) documented ileal loop reflux; h) suspected or confirmed prostatitis, urethritis, or epididymitis; i) trauma to pelvis/urinary tract.
  • Has severe impairment of renal function.
  • Has a seizure disorder or is anticipated to be treated with divalproex sodium or valproic acid during the course of study treatment.
  • Is receiving, or is expected to receive, any prohibited medications.
  • Has any rapidly progressing disease or immediately life-threatening illness, including acute hepatic failure, respiratory failure, or septic shock.
  • Has an immunocompromising condition.
  • Has a history of malignancy ≤5 years prior to signing informed consent.
  • Is planning to receive suppressive/prophylactic antibiotics with gram-negative activity after completion of study treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230838


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

  Show 48 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03230838     History of Changes
Other Study ID Numbers: 7625A-034
2016-004153-32 ( EudraCT Number )
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Anti-Infective Agents, Urinary
Pyelonephritis
Urologic Diseases
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis
Meropenem
Tazobactam
Ceftolozane
Cephalosporins
Ceftolozane, tazobactam drug combination
Penicillanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Renal Agents