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)

Completed · Phase 3

Conditions studied: Acute Bacterial Skin and Skin Structure Infections

In brief

This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and skin structure infections (ABSSSI).

Key facts

Study ID: NCT03176134
Run by: Merck Sharp & Dohme LLC
People needed: 100
Starts: 2019-01-20
Expected to finish: 2023-07-06
Last updated by the study team: 2025-07-31

Who can join

Age: 0 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Has a parent/legally acceptable representative who is able to give documented informed consent
Has acute bacterial skin and skin structure infections (ABSSSI), defined as ≥1 of the following: 1) cellulitis/erysipelas, 2) major cutaneous abscess, or 3) wound infection
Local symptoms of ABSSSI that started within 14 days before study start
Suspected or documented Gram-positive bacterial infection

You may not qualify if…

Uncomplicated skin and skin structure infection
ABSSSI due to or associated with disallowed etiology per protocol
Received antibacterial therapy for treatment of the current episode of ABSSSI except 1) <48 hours of antibacterial therapy with a short-acting antibacterial drug, or 2) response is considered to be failure (no improvement in signs and symptoms) after at least 48 hours of therapy
Known bacteremia, severe sepsis, or septic shock
Significant or life-threatening condition, disease, or organ system condition
Recent history of opportunistic infections where the underlying cause of the infection is still active, or is suspected to be at risk of opportunistic infection with unusual pathogens
Received or is receiving treatment for active tuberculosis within 1 month of study start
Known or suspected severe neutropenia
Human immunodeficiency virus (HIV) positive and has Cluster of Differentiation (CD) 4 cell count <15% (HIV testing is not required for eligibility)
Renal impairment that requires renal filtration
Severe hepatic impairment
Cardiac or electrocardiogram (ECG) finding that would limit participation in the study
Received an investigational medicinal product (not approved) within 30 days before study start
Investigational device present or removed within 30 days before study start
Previously treated with tedizolid phosphate
Contraindication, including hypersensitivity to tedizolid phosphate, other oxazolidinones, or any component in the formulation
Contraindication, including hypersensitivity to all available comparator drugs
Wound infection and history of hypersensitivity to aztreonam adjunctive therapy or metronidazole adjunctive therapy, if adjunctive therapy is required
Needs oral administration of methotrexate, topotecan, irinotecan, or rosuvastatin, during administration of oral study drug (administration during the follow-up period, ie, after the end of treatment (EOT) visit, is allowed, as is administration during treatment with IV drug)
Female who is pregnant or nursing or is of childbearing potential and not abstinent; or male who is not abstinent
Use of monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors, or serotonin 5-hydroxytryptamine receptor agonists (triptans)
Identified as having used illicit drugs (urine drug screening not required for entry)

Where it is running

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0129) — Chicago, Illinois, United States
Children's Hospital of Michigan ( Site 0100) — Detroit, Michigan, United States
William Beaumont Hospital ( Site 0108) — Royal Oak, Michigan, United States
St. Louis Children's Hospital ( Site 0127) — St Louis, Missouri, United States
Cook Children's Medical Center ( Site 0124) — Fort Worth, Texas, United States
Baylor College of Medicine - Texas Children's Hospital ( Site 0107) — Houston, Texas, United States
Children's Hospital of Richmond at VCU ( Site 0123) — Richmond, Virginia, United States
Hospital Pequeno Principe ( Site 0276) — Curitiba, Paraná, Brazil
Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0277) — Recife, Pernambuco, Brazil
Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCL-CENTRO DE ESTUDOS E PESQUISAS EM MOLES — Natal, Rio Grande do Norte, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)-Hospital São Luiz Jabaquara ( Site 0283) — São Paulo, Brazil
MHAT Sv. Nikolay Chudotvorets EOOD ( Site 0338) — Lom, Montana, Bulgaria
UMHAT Deva Maria ( Site 0333) — Burgas, Bulgaria
MHAT City Clinic Sv. Georgi EOOD ( Site 0334) — Montana, Bulgaria
MHAT Dr. Stamen Iliev AD ( Site 0339) — Montana, Bulgaria
UMHAT Dr. Georgi Stranski EAD ( Site 0330) — Pleven, Bulgaria
UMHAT Sv. Georgi ( Site 0332) — Plovdiv, Bulgaria
MBAL Medica Ruse EOOD ( Site 0336) — Rousse, Bulgaria
UMHAT Kanev AD ( Site 0337) — Rousse, Bulgaria
UMHATEM. N.I.Pirogov. EAD ( Site 0331) — Sofia, Bulgaria
JSC Evex Hospitals. ( Site 0601) — Batumi, Adjara, Georgia
Tbilisi State Medical University G. Zhvania Pediatric Academic Clinic ( Site 0600) — Tbilisi, K'alak'i T'bilisi, Georgia
JSC Evex Hospital ( Site 0602) — Tbilisi, Georgia
JSC Evex Hospitals ( Site 0603) — Tbilisi, Georgia
Rady Children's Hospital-San Diego ( Site 0118) — San Diego, California, United States

Full record on ClinicalTrials.gov

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