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

PHASE2CompletedINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

April 26, 2018

Primary Completion Date

December 3, 2020

Study Completion Date

December 3, 2020

Conditions
Complicated Urinary Tract InfectionPyelonephritis
Interventions
DRUG

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.

DRUG

Meropenem

Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days.

Trial Locations (52)

1083

Semmelweis Egyetem ( Site 0810), Budapest

1089

Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0801), Budapest

4032

Debreceni Egyetem Klinikai Kozpont ( Site 0803), Debrecen

4091

Inkosi Albert Luthuli Central Hospital ( Site 1902), Durban

4400

SzSzBMK es Egyetemi Oktatokorhaz Josa Andras Oktatokorhaz ( Site 0808), Nyíregyháza

6720

SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0804), Szeged

7623

PTE AOK Klinikai Kozpont ( Site 0809), Pécs

7700

Red Cross War Memorial Children's Hospital ( Site 1900), Cape Town

13210

SUNY Upstate Medical University Hospital ( Site 2510), Syracuse

26480

Eskisehir Osmangazi Unv. Tip Fakultesi ( Site 2202), Eskişehir

27157

Wake Forest Baptist Health ( Site 2520), Winston-Salem

34453

SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 2203), Istanbul

36004

Municipal Institution City Children s Clinical Hospital of Poltava City Council ( Site 2404), Poltava

44280

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 1202), Guadalajara

49100

SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 2402), Dnipro

50082

PI Kryvorizka city clinical hospital 8 ( Site 2408), Kryvyy Rig

60611

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2519), Chicago

61037

Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2410), Kharkiv

61075

Kharkiv City Children Hospital 16 ( Site 2414), Kharkiv

63110

St. Louis Children's Hospital ( Site 2508), St Louis

64710

Instituto Tecnologico y de Estudios Superiores de Monterrey ( Site 1204), Monterrey

70808

Our Lady of the Lake Hospital ( Site 2512), Baton Rouge

76014

Ivano-Frankivsk Regional Children Clinical Hospital ( Site 2411), Ivano-Frankivsk

77030

Baylor College Of Medicine ( Site 2515), Houston

90027

Children's Hospital - Los Angeles ( Site 2509), Los Angeles

92123

Rady Children's Hospital-San Diego ( Site 2505), San Diego

92868

Children's Hospital of Orange County ( Site 2502), Orange

119571

Russian Pediatric Clinical Hospital ( Site 1808), Moscow

194100

St.Petersburg State Pediatric Medical University ( Site 1811), Saint Petersburg

214018

Smolensk Regional Clinical Hospital ( Site 1800), Smolensk

355029

Regional Childrens Clinical Hospital ( Site 1805), Stavropol

400177

Spit. Cl. de Urg. Copii Cluj Napoca ( Site 1708), Cluj-Napoca

500063

Spitalul Clinic de Urgenta pentru Copii Brasov ( Site 1703), Brasov

115 27

Pan and Aglaia Kyriakou Children s Hospital ( Site 0780), Athens

University of Athens - Aghia Sophia Childrens Hospital ( Site 0730), Athens

124 62

Athens University Hospital ATTIKON ( Site 0790), Athens

546 42

Hippokration General Hospital of Thessaloniki ( Site 0700), Thessaloniki

411 10

General University Hospital of Larissa ( Site 0740), Larissa

04530

Instituto Nacional de Pediatria ( Site 1201), Mexico City

06720

Hospital Infantil de Mexico Federico Gomez ( Site 1203), Mexico City

85-030

Wojewodzki Szpital Obserwacyjno Zakazny ( Site 1606), Bydgoszcz

85-094

Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 1600), Bydgoszcz

87-100

Wojewodzki Szpital Zespolony im. Rydgiera ( Site 1607), Torun

30-663

Uniw. Szpital Dzieciecy w Krakowie ( Site 1609), Krakow

05-092

SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1608), Łomianki

93-338

Instytut Centrum Zdrowia Matki Polki ( Site 1602), Lodz

041451

Spitalul Clinic de Urgenta pentru Copii Maria Sklodowska Curie ( Site 1707), Bucharest

021106

Institutul National de Boli Infectioase Prof. Dr. Matei Bals ( Site 1706), Bucharest

0208

Molotlegi Street ( Site 1903), Pretoria

01330

Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 2200), Adana

06230

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2201), Ankara

01135

National Children Specialised Hospital OHMADYT MOH Ukraine ( Site 2409), Kyiv

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03230838 - MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034) | Biotech Hunter | Biotech Hunter