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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
134
12 to \<18 years of age: Ceftolozane 1 g/dose; Tazobactam 0.5 g/dose via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days. \<12 years of age: Ceftolozane 20 mg/kg with Tazobactam 10 mg/kg (not to exceed Ceftolozane 1 g and Tazobactam 0.5 g) via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days.
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days.
Number of Participants With ≥1 Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time frame: Up to Day 88
Number of Participants Discontinuing Study Therapy Due to AE
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time frame: Up to Day 15
Percentage of Participants With a Clinical Response of Cure at the Test of Cure Visit
Clinical response of cure is complete resolution or marked improvement in signs and symptoms of the complicated urinary tract infection (cUTI) or return to pre-infection signs and symptoms, such that no further antibiotic therapy (IV or oral) is required for the treatment of the cUTI. The 95% confidence intervals (CIs) of each treatment are unstratified Wilson CIs.
Time frame: Up to Test of Cure Visit (up to 35 days)
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Children's Hospital - Los Angeles ( Site 2509)
Los Angeles, California, United States
Children's Hospital of Orange County ( Site 2502)
Orange, California, United States
Rady Children's Hospital-San Diego ( Site 2505)
San Diego, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2519)
Chicago, Illinois, United States
Our Lady of the Lake Hospital ( Site 2512)
Baton Rouge, Louisiana, United States
St. Louis Children's Hospital ( Site 2508)
St Louis, Missouri, United States
SUNY Upstate Medical University Hospital ( Site 2510)
Syracuse, New York, United States
Wake Forest Baptist Health ( Site 2520)
Winston-Salem, North Carolina, United States
Baylor College Of Medicine ( Site 2515)
Houston, Texas, United States
Pan and Aglaia Kyriakou Children s Hospital ( Site 0780)
Athens, Attica, Greece
...and 42 more locations
Percentage of Participants With a Clinical Response of Cure at the End of Treatment Visit
Clinical response of cure is complete resolution or marked improvement in signs and symptoms of the cUTI or return to pre-infection signs and symptoms, such that no further antibiotic therapy (IV or oral) is required for the treatment of the cUTI. The 95% CIs of each treatment are unstratified Wilson CIs.
Time frame: Up to 48 hours after last oral dose (up to 19 days)
Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the Test of Cure Visit
Microbiological eradication of all baseline pathogens is defined as a postbaseline urine culture shows all uropathogens found at baseline at ≥10\^5 colony-forming units (CFU)/mL are reduced to \<10\^4 CFU/mL. The 95% CIs of each treatment are unstratified Wilson CIs.
Time frame: Up to Test of Cure Visit (up to 35 days)
Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the End of Treatment Visit
Microbiological eradication of all baseline pathogens is defined as a postbaseline urine culture shows all uropathogens found at baseline at ≥10\^5 colony-forming units (CFU)/mL are reduced to \<10\^4 CFU/mL. The 95% CIs of each treatment are unstratified Wilson CIs.
Time frame: Up to 48 hours after last oral dose (up to 19 days)