Last updated on December 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute Bacterial Skin and Skin Structure Infections
  • Age: - 11 Years
  • Gender: Male or Female

Inclusion Criteria:

  • ABSSSI, defined as one of the following: 1) cellulitis/erysipelas, 2) major cutaneous abscess, 3) wound infection
  • Local symptoms of ABSSSI that started within 7 days before study start
  • Suspected or documented Gram-positive bacterial infection
  • Body weight >5th percentile and <95th percentile based on age.

Exclusion Criteria:

  • 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. <24 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
  • Topical antibacterial applied and remaining on the primary lesion >24 hours before randomization
  • 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 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
  • Currently receiving topotecan, irinotecan, methotrexate, or rosuvastatin
  • 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).

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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