A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)

PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

November 6, 2017

Primary Completion Date

July 28, 2020

Study Completion Date

August 11, 2020

Conditions
Suspected or Documented Gram-negative Bacterial Infection
Interventions
DRUG

IMI/REL FDC

IMI/REL is supplied as a single fixed dose combination (FDC) vial; which is administered at a maximum dose of 15 mg/kg IMI and 15 mg/kg CIL (up to 500 mg IMI and 500 mg CIL) and 7.5 mg/kg REL (up to 250 mg REL).

Trial Locations (33)

1478

Akershus Universitetssykehus HF ( Site 0903), Loerenskog

4011

Stavanger Universitetssykehus, Helse Stavanger ( Site 0901), Stavanger

4400

MHAT Pazardjik AD ( Site 0208), Pazardzhik

5021

Haukeland Universitetssjukehus ( Site 0902), Bergen

5800

UMHAT Dr. Georgi Stranski EAD ( Site 0211), Pleven

7002

UMHAT Kanev AD ( Site 0203), Rousse

UMHAT Kanev AD ( Site 0212), Rousse

7006

St. Olavs Hospital ( Site 0900), Trondheim

8127

UMHAT Deva Maria. EOOD ( Site 0209), Burgas

19104

The Children's Hospital of Philadelphia ( Site 1318), Philadelphia

27710

Duke University Medical Center ( Site 1317), Durham

36004

Children City Clinical Hospital ( Site 1215), Poltava

49100

SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1214), Dnipro

61075

Kharkiv City Children Hospital 16 ( Site 1200), Kharkiv

63110

St. Louis Children's Hospital ( Site 1322), St Louis

65031

Odessa Regional Children Clinical Hospital ( Site 1203), Odesa

69063

Zaporizhzhya Regional Clinical Childrens Hospital ( Site 1202), Zaporizhzhya

70808

Our Lady of the Lake Hospital ( Site 1304), Baton Rouge

72202

Arkansas Children's Hospital ( Site 1311), Little Rock

92123

Rady Children's Hospital-San Diego ( Site 1305), San Diego

92868

Children's Hospital of Orange County ( Site 1301), Orange

98105

Seattle Childrens Hospital ( Site 1321), Seattle

500515

Hospital General de Medellin Luz Castro de Gutierrez ( Site 0303), Medellín

760032

Fundacion Valle del Lili ( Site 0300), Santiago de Cali

050034

Hospital Pablo Tobon Uribe ( Site 0301), Medellín

546 42

General Hospital of Thessaloniki Hippokrateio ( Site 1402), Thessaloniki

05-092

SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1002), Łomianki

91-347

Wojewodzki Specjalistyczny Szpital im. Bieganskiego w Lodzi ( Site 1000), Lodz

04050

Institution of Pediatr Obstetr and Gynec NAMS of Ukraine ( Site 1213), Kyiv

BS2 8AF

Bristol Royal Hospital for Children ( Site 1101), Bristol

SO16 6YD

University Hospital Southampton NHS Foundation Trust ( Site 1100), Southampton

SW17 0QT

St. Georges University Hospital NHS Foundation Trust ( Site 1103), London

NE1 4LP

Great Northern Children s Hospital ( Site 1102), Newcastle

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03230916 - A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020) | Biotech Hunter | Biotech Hunter