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MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT03230838•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 17 years

Sex

ALL

Healthy Volunteers

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 reaction, or other contraindication to any of the following: β-lactam antibiotics (e.g, penicillins, cephalosporins, and carbapenems), β-lactamase inhibitors (e.g. 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 therapy.
•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 moderate or 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.
+4 more criteria

Locations (52)

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

Key Dates

Start Date

April 26, 2018

Primary Completion Date

December 3, 2020

Completion Date

December 3, 2020

Last Updated

May 6, 2023

Enrollment

134

ACTUAL participants

Conditions

Complicated Urinary Tract InfectionPyelonephritis

Interventions

Ceftolozane/Tazobactam

DRUG

Meropenem

DRUG

Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

NCT04876131

Complicated Urinary Tract InfectionInfection+1 more

View study

RECRUITINGPHASE2

A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI

NCT05826990

Complicated Urinary Tract Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

Factors and Prognosis of Obstructive Pyelonephritis Patients

Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections