MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)

Conditions:Infectious Disease, Nephrology, Urology
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Age Range:Any - 17
Start Date:April 26, 2018
End Date:September 6, 2020
Contact:Toll Free Number

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A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Versus Meropenem in Pediatric Subjects With Complicated Urinary Tract Infection, Including Pyelonephritis

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

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

- 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 (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 a history of a cUTI 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

- Has received potentially therapeutic antibacterial therapy for a duration more than 24
hours during the 48 hours preceding the first dose of study treatment.

- Has any of the following: a) intractable UTI or pyelonephritis infection at baseline
that the Investigator anticipates would require more than 14 days of study treatment;
b) confirmed fungal urinary tract infection at time of randomization; c) permanent
indwelling bladder catheter or instrumentation including nephrostomy; d) current
urinary catheter that is not scheduled to be removed before the end of all study
treatment; e) complete, permanent obstruction of the urinary tract; f) suspected or
confirmed perinephric or intrarenal abscess; g) documented ileal loop reflux; h)
suspected or confirmed prostatitis, urethritis, or epididymitis; i) trauma to
pelvis/urinary tract.

- Has 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.
We found this trial at
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Phone: 832-824-5650
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
Houston, TX
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Phone: 323-361-5047
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
Los Angeles, CA
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Phone: 714-509-4791
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
Orange, CA
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Phone: 858-966-7785
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
San Diego, CA
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750 E Adams St
Syracuse, New York 13210
(315) 464-5540
Phone: 315-464-7353
SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
Syracuse, NY
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Baton Rouge, Louisiana 70808
Phone: 225-765-4365
Baton Rouge, LA
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Phone: 312-227-6280
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
Chicago, IL
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Saint Louis, Missouri 63110
Phone: 314-747-5128
Saint Louis, MO
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Winston-Salem, North Carolina 27157
Phone: 336-716-9640
Winston-Salem, NC
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