MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abd… (NCT03217136) | Clinical Trial Compass
CompletedPhase 2
MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)
United States94 participantsStarted 2018-04-03
Plain-language 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.
Who can participate
Age range7 Days – 17 Years
SexALL
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Inclusion Criteria:
* Has a legally acceptable representative who provides documented informed consent/assent 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…
What they're measuring
1
Number of Participants Experiencing ≥1 Adverse Events (AEs)
Timeframe: Up to approximately 75 days
2
Number of Participants Who Discontinued Study Therapy Due to AE(s)