MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)
- Conditions
- PyelonephritisComplicated Urinary Tract Infection
- Interventions
- Registration Number
- NCT03230838
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ceftolozane/Tazobactam 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 Meropenem Meropenem Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days
- Primary Outcome Measures
Name Time Method Number of Participants Discontinuing Study Therapy Due to AE Up to Day 15 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.
Number of Participants With ≥1 Adverse Events (AEs) Up to Day 88 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With a Clinical Response of Cure at the Test of Cure Visit Up to Test of Cure Visit (up to 35 days) 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.
Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the Test of Cure Visit Up to Test of Cure Visit (up to 35 days) 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.
Percentage of Participants With Microbiological Eradication of All Baseline Pathogens at the End of Treatment Visit Up to 48 hours after last oral dose (up to 19 days) 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.
Percentage of Participants With a Clinical Response of Cure at the End of Treatment Visit Up to 48 hours after last oral dose (up to 19 days) 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.
Trial Locations
- Locations (52)
SUNY Upstate Medical University Hospital ( Site 2510)
🇺🇸Syracuse, New York, United States
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2519)
🇺🇸Chicago, Illinois, United States
Baylor College Of Medicine ( Site 2515)
🇺🇸Houston, Texas, United States
Inkosi Albert Luthuli Central Hospital ( Site 1902)
🇿🇦Durban, Kwazulu-Natal, South Africa
University of Athens - Aghia Sophia Childrens Hospital ( Site 0730)
🇬🇷Athens, Attiki, Greece
PTE AOK Klinikai Kozpont ( Site 0809)
🇭🇺Pecs, Baranya, Hungary
General University Hospital of Larissa ( Site 0740)
🇬🇷Larissa, Thessalia, Greece
St.Petersburg State Pediatric Medical University ( Site 1811)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Smolensk Regional Clinical Hospital ( Site 1800)
🇷🇺Smolensk, Smolenskaya Oblast, Russian Federation
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2201)
🇹🇷Ankara, Turkey
Semmelweis Egyetem ( Site 0810)
🇭🇺Budapest, Hungary
Ivano-Frankivsk Regional Children Clinical Hospital ( Site 2411)
🇺🇦Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Pan and Aglaia Kyriakou Children s Hospital ( Site 0780)
🇬🇷Athens, Attiki, Greece
Hippokration General Hospital of Thessaloniki ( Site 0700)
🇬🇷Thessaloniki, Thessaloníki, Greece
Hospital Infantil de Mexico Federico Gomez ( Site 1203)
🇲🇽Mexico City, Mexico
Athens University Hospital ATTIKON ( Site 0790)
🇬🇷Athens, Attiki, Greece
Instytut Centrum Zdrowia Matki Polki ( Site 1602)
🇵🇱Lodz, Lodzkie, Poland
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0801)
🇭🇺Budapest, Hungary
PI Kryvorizka city clinical hospital 8 ( Site 2408)
🇺🇦Kryvyy Rig, Dnipropetrovska Oblast, Ukraine
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2410)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Municipal Institution City Children s Clinical Hospital of Poltava City Council ( Site 2404)
🇺🇦Poltava, Poltavska Oblast, Ukraine
Our Lady of the Lake Hospital ( Site 2512)
🇺🇸Baton Rouge, Louisiana, United States
SzSzBMK es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz ( Site 0808)
🇭🇺Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary
Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 1204)
🇲🇽Monterrey, Nuevo Leon, Mexico
Uniw. Szpital Dzieciecy w Krakowie ( Site 1609)
🇵🇱Krakow, Malopolskie, Poland
Spit. Cl. de Urg. Copii Cluj Napoca ( Site 1708)
🇷🇴Cluj-Napoca, Cluj, Romania
Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 1703)
🇷🇴Brasov, Romania
SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1608)
🇵🇱Lomianki, Mazowieckie, Poland
Spitalul Clinic de Urgenta pentru Copii Maria Sklodowska Curie ( Site 1707)
🇷🇴Bucharest, Bucuresti, Romania
Russian Pediatric Clinical Hospital ( Site 1808)
🇷🇺Moscow, Moskva, Russian Federation
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 2402)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
National Children Specialised Hospital OHMADYT MOH Ukraine ( Site 2409)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Rady Children's Hospital-San Diego ( Site 2505)
🇺🇸San Diego, California, United States
Wake Forest Baptist Health ( Site 2520)
🇺🇸Winston-Salem, North Carolina, United States
Children's Hospital - Los Angeles ( Site 2509)
🇺🇸Los Angeles, California, United States
Children's Hospital of Orange County ( Site 2502)
🇺🇸Orange, California, United States
St. Louis Children's Hospital ( Site 2508)
🇺🇸Saint Louis, Missouri, United States
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0804)
🇭🇺Szeged, Csongrad, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0803)
🇭🇺Debrecen, Hungary
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 1202)
🇲🇽Guadalajara, Jalisco, Mexico
Instituto Nacional de Pediatria ( Site 1201)
🇲🇽Mexico City, Mexico
Wojewodzki Szpital Obserwacyjno Zakazny ( Site 1606)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 1600)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Wojewodzki Szpital Zespolony im. Rydgiera ( Site 1607)
🇵🇱Torun, Kujawsko-pomorskie, Poland
Institutul National de Boli Infectioase Prof. Dr. Matei Bals ( Site 1706)
🇷🇴Bucuresti, Romania
Regional Childrens Clinical Hospital ( Site 1805)
🇷🇺Stavropol, Stavropol Skiy Kray, Russian Federation
Molotlegi Street ( Site 1903)
🇿🇦Pretoria, Gauteng, 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
Eskisehir Osmangazi Unv. Tip Fakultesi ( Site 2202)
🇹🇷Eskisehir, Turkey
SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 2203)
🇹🇷Istanbul, Turkey
Kharkiv City Children Hospital 16 ( Site 2414)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine