A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)

PHASE3CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 20, 2019

Primary Completion Date

July 6, 2023

Study Completion Date

July 6, 2023

Conditions
Acute Bacterial Skin and Skin Structure Infections
Interventions
DRUG

Tedizolid phosphate

Tedizolid phosphate IV solution or oral suspension

DRUG

Comparator

Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral provided locally by the trial site and administered per local standard of care

Trial Locations (58)

1606

UMHATEM. N.I.Pirogov. EAD ( Site 0331), Sofia

3400

MHAT City Clinic Sv. Georgi EOOD ( Site 0334), Montana

MHAT Dr. Stamen Iliev AD ( Site 0339), Montana

3414

Liepaja Regional Hospital ( Site 0652), Liepāja

3600

MHAT Sv. Nikolay Chudotvorets EOOD ( Site 0338), Lom

4002

UMHAT Sv. Georgi ( Site 0332), Plovdiv

4013

Enhancing Care Foundation-DICRS ( Site 0381), Durban

5417

Daugavpils Regional Hospital ( Site 0651), Daugavpils

5800

UMHAT Dr. Georgi Stranski EAD ( Site 0330), Pleven

6010

JSC Evex Hospitals. ( Site 0601), Batumi

7000

MBAL Medica Ruse EOOD ( Site 0336), Rousse

7002

UMHAT Kanev AD ( Site 0337), Rousse

8127

UMHAT Deva Maria ( Site 0333), Burgas

20259

Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0239), Aguascalientes

23219

Children's Hospital of Richmond at VCU ( Site 0123), Richmond

26480

Osmangazi UTF ( Site 0357), Eskişehir

34093

Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0355), Istanbul

34371

Sisli Hamide Etfal Egitim ve Arastirma Hastanesi ( Site 0358), Istanbul

35040

Ege UTF ( Site 0356), Izmir

44280

Hospital Civil Fray Antonio Alcalde-pediatrics infectious diseases ( Site 0230), Guadalajara

48073

William Beaumont Hospital ( Site 0108), Royal Oak

48201

Children's Hospital of Michigan ( Site 0100), Detroit

49100

Dnipropetrovsk Oblast Children's Clinical Hospital ( Site 0868), Dnipro

SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0863), Dnipro

50161

Hospital of Lithuanian University of Health Sciences Kaunas ( Site 0701), Kaunas

60611

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0129), Chicago

63110

St. Louis Children's Hospital ( Site 0127), St Louis

64060

CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 0241), General Escobedo

76014

Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0865), Ivano-Frankivsk

76104

Cook Children's Medical Center ( Site 0124), Fort Worth

77030

Baylor College of Medicine - Texas Children's Hospital ( Site 0107), Houston

80337

Haunersches Kinderspital ( Site 0480), München

92123

Rady Children's Hospital-San Diego ( Site 0118), San Diego

92140

Klaipedos Vaiku Ligonine ( Site 0700), Klaipėda

214018

Smolensk Regional Clinical Hospital ( Site 0511), Smolensk

420138

Children s Republican Clinical Hospital ( Site 0512), Kazan'

630007

City Childrens Clinical Emergency Hospital ( Site 0507), Novosibirsk

80250-060

Hospital Pequeno Principe ( Site 0276), Curitiba

50070-902

Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0277), Recife

59025-050

Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCL-CENTRO DE ESTUDOS E PESQUISAS EM MOLES, Natal

04321-120

Instituto D'Or de Pesquisa e Ensino (IDOR)-Hospital São Luiz Jabaquara ( Site 0283), São Paulo

0159

Tbilisi State Medical University G. Zhvania Pediatric Academic Clinic ( Site 0600), Tbilisi

JSC Evex Hospital ( Site 0602), Tbilisi

JSC Evex Hospitals ( Site 0603), Tbilisi

01001

Clinica Privada ( Site 0551), Guatemala City

01009

Private Practice Mario Melgar ( Site 0552), Guatemala City

01010

Private Practice Dra. Manrique ( Site 0553), Guatemala City

08406

Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0702), Vilnius

04530

Instituto Nacional de Pediatria ( Site 0231), Mexico City

06720

Hospital Infantil de Mexico Federico Gomez ( Site 0227), Mexico City

85-030

Wojewodzki Szpital Obserwacyjno Zakazny ( Site 0429), Bydgoszcz

05-092

SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0431), Łomianki

91-347

Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 0427), Lodz

0084

Emmed Research Incorporating ( Site 0377), Pretoria

0152

Setshaba Research Centre ( Site 0378), Pretoria

01330

Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0353), Adana

06230

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0351), Ankara

06800

Ankara City Hospital-Infectious Disease and Clinical Microbiology ( Site 0359), Ankara

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03176134 - A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018) | Biotech Hunter | Biotech Hunter