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MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03217136
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : February 17, 2020
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) plus metronidazole, compared with that of meropenem in pediatric participants with cIAI.

Condition or disease Intervention/treatment Phase
Complicated Intra-Abdominal Infection Drug: Ceftolozane Drug: Tazobactam Drug: Metronidazole Drug: Meropenem Drug: Placebo for Metronidazole 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) Plus Metronidazole Versus Meropenem in Pediatric Subjects With Complicated Intra-Abdominal Infection
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : June 18, 2021
Estimated Study Completion Date : June 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ceftolozane/Tazobactam + Metronidazole
Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum ceftolozane 1 g/dose and tazobactam 0.5 g/dose); plus Metronidazole 10 mg/kg (maximum 1.5 g/day) administered intravenously (IV) every 8 to 12 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 5 days and a maximum of 14 days.
Drug: Ceftolozane
Ceftolozane 20 mg/kg (maximum 1 g) administered IV every 8 hours for between 5 to 14 day

Drug: Tazobactam
Tazobactam 10 mg/kg (maximum 0.5 g/dose) administered IV every 8 hours for between 5 to 14 days

Drug: Metronidazole
Metronidazole 10 mg/kg (maximum 1.5 g/day) administered IV every 8 hours for between 5 to 14 days. Participants =< 28 days old, start with a loading dose of 15 mg/kg; then if =< 2 kg are dosed 7.5 mg/kg/ every 12 hours; or if > 2 kg are dosed 10 mg/kg every 8 hours.

Active Comparator: Meropenem + Placebo for Metronidazole
Meropenem 20 mg/kg (maximum 1 g/dose) plus placebo for Metronidazole 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 5 days and a maximum of 14 days.
Drug: Meropenem
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 5 to 14 days

Drug: Placebo for Metronidazole
Placebo for Metronidazole administered IV every 8 hours for between 5 to 14 days.




Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to Day 42 ]
    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 28 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 28 days) ]
    Percentage of participants who have microbiological eradication or presumed eradication of all baseline pathogens.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
  • Aged from birth (defined as >32 weeks gestational age and ≥7 days postnatal) to <18 years of age.
  • Require IV antibacterial therapy for the treatment of presumed or documented cIAI.
  • Has an operative procedure for the current diagnosis and management of cIAI planned or completed within 24 hours of the first dose of an antibacterial drug. Note: Participants with a diagnosis of necrotizing enterocolitis are exempt and not required to have surgery planned or completed in order to be eligible.
  • Has in compliance baseline intra-abdominal specimen collection.
  • 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 an IAI 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, unless is considered to be failing antibiotic therapy for cIAI.
  • Has any of the following: a) intractable cIAI that the investigator anticipates would require more than 14 days of study treatment; b) abdominal wall abscess; c) small bowel obstruction; d) ischemic bowel disease without perforation; e) traumatic bowel perforation with surgery within 12 hours of perforation; f) perforation of gastroduodenal ulcers requiring surgery within 24 hours of perforation; g) suspected uncomplicated intra-abdominal infection (eg, cholecystitis without rupture or extension beyond the gallbladder wall); h) acute suppurative cholangitis; i) infected necrotizing pancreatitis; j) pancreatic abscess.
  • Has moderate or 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): NCT03217136


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

Locations
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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: NCT03217136    
Other Study ID Numbers: 7625A-035
2016-004820-41 ( EudraCT Number )
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
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
Intraabdominal Infections
Metronidazole
Meropenem
Tazobactam
Ceftolozane
Cephalosporins
Ceftolozane, tazobactam drug combination
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents