MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)
NCT ID: NCT03230838
Last Updated: 2023-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
134 participants
INTERVENTIONAL
2018-04-26
2020-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ceftolozane/Tazobactam
Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose) administered intravenously (IV) every 8 hours for 7-14 days
Ceftolozane/Tazobactam
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
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days
Meropenem
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days.
Interventions
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Ceftolozane/Tazobactam
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
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* 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.
7 Days
17 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
University of Athens - Aghia Sophia Childrens Hospital ( Site 0730)
Athens, Attica, Greece
Athens University Hospital ATTIKON ( Site 0790)
Athens, Attica, Greece
Hippokration General Hospital of Thessaloniki ( Site 0700)
Thessaloniki, Thessaloníki, Greece
General University Hospital of Larissa ( Site 0740)
Larissa, Thessaly, Greece
PTE AOK Klinikai Kozpont ( Site 0809)
Pécs, Baranya, Hungary
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0804)
Szeged, Csongrád megye, Hungary
SzSzBMK es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz ( Site 0808)
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Semmelweis Egyetem ( Site 0810)
Budapest, , Hungary
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0801)
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0803)
Debrecen, , Hungary
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 1202)
Guadalajara, Jalisco, Mexico
Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 1204)
Monterrey, Nuevo León, Mexico
Instituto Nacional de Pediatria ( Site 1201)
Mexico City, , Mexico
Hospital Infantil de Mexico Federico Gomez ( Site 1203)
Mexico City, , Mexico
Wojewodzki Szpital Obserwacyjno Zakazny ( Site 1606)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 1600)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Wojewodzki Szpital Zespolony im. Rydgiera ( Site 1607)
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Uniw. Szpital Dzieciecy w Krakowie ( Site 1609)
Krakow, Lesser Poland Voivodeship, Poland
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1608)
Łomianki, Masovian Voivodeship, Poland
Instytut Centrum Zdrowia Matki Polki ( Site 1602)
Lodz, Łódź Voivodeship, Poland
Spitalul Clinic de Urgenta pentru Copii Maria Sklodowska Curie ( Site 1707)
Bucharest, București, Romania
Spit. Cl. de Urg. Copii Cluj Napoca ( Site 1708)
Cluj-Napoca, Cluj, Romania
Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 1703)
Brasov, , Romania
Institutul National de Boli Infectioase Prof. Dr. Matei Bals ( Site 1706)
Bucharest, , Romania
Russian Pediatric Clinical Hospital ( Site 1808)
Moscow, Moscow, Russia
St.Petersburg State Pediatric Medical University ( Site 1811)
Saint Petersburg, Sankt-Peterburg, Russia
Smolensk Regional Clinical Hospital ( Site 1800)
Smolensk, Smolensk Oblast, Russia
Regional Childrens Clinical Hospital ( Site 1805)
Stavropol, Stavropol Kray, Russia
Molotlegi Street ( Site 1903)
Pretoria, Gauteng, South Africa
Inkosi Albert Luthuli Central Hospital ( Site 1902)
Durban, KwaZulu-Natal, South Africa
Red Cross War Memorial Children's Hospital ( Site 1900)
Cape Town, Western Cape, South Africa
Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2200)
Adana, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2201)
Ankara, , Turkey (Türkiye)
Eskisehir Osmangazi Unv. Tip Fakultesi ( Site 2202)
Eskişehir, , Turkey (Türkiye)
SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 2203)
Istanbul, , Turkey (Türkiye)
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 2402)
Dnipro, Dnipropetrovsk Oblast, Ukraine
PI Kryvorizka city clinical hospital 8 ( Site 2408)
Kryvyy Rig, Dnipropetrovsk Oblast, Ukraine
Ivano-Frankivsk Regional Children Clinical Hospital ( Site 2411)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2410)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Kharkiv City Children Hospital 16 ( Site 2414)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
National Children Specialised Hospital OHMADYT MOH Ukraine ( Site 2409)
Kyiv, Kyivska Oblast, Ukraine
Municipal Institution City Children s Clinical Hospital of Poltava City Council ( Site 2404)
Poltava, Poltava Oblast, Ukraine
Countries
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References
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Roilides E, Ashouri N, Bradley JS, Johnson MG, Lonchar J, Su FH, Huntington JA, Popejoy MW, Bensaci M, De Anda C, Rhee EG, Bruno CJ. Safety and Efficacy of Ceftolozane/Tazobactam Versus Meropenem in Neonates and Children With Complicated Urinary Tract Infection, Including Pyelonephritis: A Phase 2, Randomized Clinical Trial. Pediatr Infect Dis J. 2023 Apr 1;42(4):292-298. doi: 10.1097/INF.0000000000003832. Epub 2023 Jan 23.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-004153-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7625A-034
Identifier Type: -
Identifier Source: org_study_id
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