NCT03643952 - Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 6, 2018

Primary Completion Date

April 7, 2020

Study Completion Date

April 7, 2020

Conditions

BacteremiaSoft Tissue InfectionsSkin Diseases, Infectious

Interventions

DRUG

Daptomycin for Injection

Once daily administration of 5, 7, 9, 10, or 12 mg/kg intravenous (IV) daptomycin infused with 25-50 mL saline over 30-60 minutes depending upon infection type and age level.

Trial Locations (16)

457-8510

Japan Community Health Care Organization Chukyo Hospital ( Site 0030), Nagoya

806-8501

Japan Community Health care Organization Kyushu Hospital ( Site 0016), Kitakyushu

371-0811

Maebashi Red Cross Hospital ( Site 0012), Maebashi

650-0017

Kobe University Hospital ( Site 0015), Kobe

765-8507

Shikoku Medical Center for Children and Adults ( Site 0027), Zentsujichó

227-8501

Showa University Fujigaoka Hospital ( Site 0023), Yokohama

232-8555

Kanagawa Children's Medical Center ( Site 0025), Yokohama

514-0125

National Hospital Organization National Mie Hospital ( Site 0002), Tsu

874-0011

National Hospital Organization Beppu Medical Center ( Site 0003), Beppu

183-8561

Tokyo Metropolitan Children's Medical Center ( Site 0004), Fuchū

260-8677

Chiba University Hospital ( Site 0005), Chiba

266-0007

Chiba Children's Hospital ( Site 0024), Chiba

860-0008

National Hospital Organization Kumamoto Medical Center ( Site 0018), Kumamoto

534-0021

Osaka City General Hospital ( Site 0020), Osaka

336-8522

Saitama City Hospital ( Site 0008), Saitama

173-8610

Nihon University Itabashi Hospital ( Site 0029), Tokyo

All Listed Sponsors

lead

Merck Sharp & Dohme LLC

INDUSTRY