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Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem in Pediatric Subjects with Complicated Intra-Abdominal Infection


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 
Therapeutic Area Abdominal Infection
Principal Investigator Carl-Christian A. Jackson, MD, F.A.C.S.
Min Age 0 Years
Max Age 18 Years
Gender Any
Contact Vidya Iyer
617-636-0186
More Information https://www.clinicaltrials.gov/ct2/show/NCT03217136

Overview

This trial evaluates the safety and efficacy of ceftolozane/tazobactam (MK-7625A) plus metronidazole versus meropenem plus placebo in pediatric subjects from birth (defined as >32 weeks gestational age and >7 days postnatal) to <18 years of age with complicated intraabdominal infection (cIAI). The total duration of study treatment (IV only or IV + oral) is a minimum of 5 days and maximum of 14 days. After receiving at least 9 doses of double-blind IV study treatment, subjects in either treatment arm may be switched to open-label, standard of-care oral step-down antibiotic therapy at the investigator's discretion. Oral step-down therapy is considered study treatment.

Study Details

Inclusion Criteria

  • Require IV antibacterial therapy for the treatment of presumed or documented cIAI
  • Have 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
  • Female or male either not of reproductive potential, or 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. 

Exclusion Criteria

  • Previously participated in any trial of ceftolozane/tazobactam or has enrolled previously in the current trial and been discontinued.
  • 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 history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that, in the opinion of the investigator, might expose the subject to increased risk by participating in the trial, confound the results of the trial, or interfere with the subjects's participation for the full duration of the trial.

Study Requirements

21 Visits

Subjects will be randomized to receive either Ceftolozane/tazobactum + metronidazole or Meropenem + placebo (look-alike with no active ingredients)

Subjects will receive the drug from a minimum of 5 days to a maximum of 14 days. They stay in the hospital during the IV study treatment.

Dose of the drug will be based on the age and weight and will be given as 60 minutes infusions (into a vein) approximately every 8 hours (3 times a day) throughout the IV dosing period. 

After receiving at least 9 doses of study drug, subject may be switched to an antibiotic that is available by prescription and can be taken orally.

At each office visit, any or all of the following may be performed:

  • Administered the study drug.
  • Review your health history and ask how you are feeling.
  • Check to see what medications you are taking or any that you have taken recently.
  • Perform physical exam and check your surgical wound, if applicable.
  • Check your weight and height.
  • Check your vital signs (including blood pressure, heart rate, temperature, breathing rate).
  • Check if you have or have had any side effects (serious or non-serious).
  • Collect blood and urine samples.
  • Collect sample from the site of infection in your abdomen, if applicable.