MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUT… (NCT03230838) | Clinical Trial Compass
CompletedPhase 2
MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)
United States134 participantsStarted 2018-04-26
Plain-language 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.
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.
* 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 (e.g.anaphylaxis), allergic r…
What they're measuring
1
Number of Participants With ≥1 Adverse Events (AEs)
Timeframe: Up to Day 88
2
Number of Participants Discontinuing Study Therapy Due to AE