Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)

PHASE1CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

April 17, 2020

Primary Completion Date

September 14, 2024

Study Completion Date

September 14, 2024

Conditions
Nosocomial Pneumonia
Interventions
DRUG

Ceftolozane/Tazobactam

"Participants 12 to \<18 years of age: IV ceftolozane 2 g with tazobactam 1 g infused over a 60-minute period.~Participants \<12 years of age: IV ceftolozane 40 mg/kg with tazobactam 20 mg/kg infused over a 60-minute period (not to exceed a dose of ceftolozane 2g and tazobactam 1 g)."

Trial Locations (24)

10467

Montefiore Medical Center [Bronx, NY] ( Site 1313), New York

13419

SA Tallinna Lastehaigla/Tallinn Children's Hospital ( Site 0201), Tallinn

26506

West Virginia University ( Site 1310), Morgantown

32803

AdventHealth Orlando ( Site 1318), Orlando

49100

SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1205), Dnipro

50406

SA Tartu Ulikooli Kliinikum Lastekliinik ( Site 0200), Tartu

53226

Children's Wisconsin ( Site 1321), Milwaukee

55902

Mayo Clinic in Rochester, Minnesota ( Site 1322), Rochester

57105

Sanford Children's Hospital ( Site 1301), Sioux Falls

61075

Kharkiv City Children Hospital 16 ( Site 1200), Kharkiv

76018

Ivano-Frankivsk Regional Children Clinical Hospital ( Site 1204), Ivano-Frankivsk

119049

Morozovskaya Children City Clinical Hospital ( Site 0901), Moscow

194156

St. Olga Children City Hospital ( Site 0906), Saint Petersburg

214018

Smolensk Regional Clinical Hospital ( Site 0903), Smolensk

230002

Oncomédica S.A.S ( Site 1506), Montería

8380418

Hospital Roberto del Río ( Site 1400), Santiago

0500515

Hospital General de Medellin ( Site 1503), Medellín

08001

Ciensalud Ips S A S ( Site 1501), Barranquilla

080020

Clinica de la Costa S.A.S. ( Site 1500), Barranquilla

546 42

Hippokration General Hospital of Thessaloniki ( Site 0400), Thessaloniki

04530

Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 1602), Mexico City

06720

Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 1600), Mexico City

08950

Hospital Universitario Sant Joan de Deu ( Site 1100), Esplugues de Llobregat

04050

Institution of Pediatr Obstetr and Gynec NAMS of Ukraine ( Site 1203), Kyiv

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04223752 - Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036) | Biotech Hunter | Biotech Hunter