Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections (OTTER)
Condition: Bone and Joint Infection
MeSH terms: Infections; Communicable Diseases; Arthritis, Infectious
Study type: Interventional
Phase: Phase 2

Summary: 
      The problem of interest is that doctors are looking for new antibiotic treatments for bone
      and joint infections. Treatment for bone and joint infection is not standardized, which
      allows a wide range of antibiotic therapy to potentially be given. A type of bacteria called
      S. aureus is the most common cause of bone and joint infection. Methicillin resistant S.
      aureus (MRSA) is a type of bacteria that is not killed by some antibiotics, and it is
      increasingly common in U.S. and non-U.S. medical centers. This problem will be studied by
      investigating whether an antibiotic called tedizolid is tolerable, safe and effective to
      treat bone and joint infections.
    

Detailed description: 
      The problem of interest is that doctors are looking for new antibiotic treatments for bone
      and joint infections. Treatment for bone and joint infection is not standardized, which
      allows a wide range of antibiotic therapy to potentially be given. A type of bacteria called
      S. aureus is the most common cause of bone and joint infection. Methicillin resistant S.
      aureus (MRSA) is a type of bacteria that is not killed by some antibiotics, and it is
      increasingly common in U.S. and non-U.S. medical centers. Trauma-associated bone and joint
      infection is also a common problem. Victims of major trauma often suffer bone fractures,
      which require temporary or permanent use of metal or other synthetic devices such as
      external-fixation pins, plates, and screws. These synthetic devices can also get infected and
      cause bone and joint infections.

      This problem will be studied by investigating whether an antibiotic called tedizolid is
      tolerable, safe and effective to treat bone and joint infections. Tedizolid is a new
      FDA-approved antibiotic, and can be given through the bloodstream via an IV or orally in the
      form of a pill. Tedizolid has less side effects compared to linezolid and is effective
      against types of bacteria like S. aureus. Other research also suggests that the side effects
      associated with long-term therapy of older types of antibiotics may not be found with
      tedizolid.

      This study will advance scientific knowledge of antibiotic treatments for bone and joint
      infections. Given the large and increasing burden of disease of bone and joint infection and
      the increasing acceptability of oral antibiotics for its management, tedizolid holds promise
      as a good option for patients with bone and joint infection. Harbor-UCLA Medical Center is a
      large medical center in the County of Los Angeles, the most populous County in the United
      States. The Infectious Disease consult service sees many bone and joint infections. Use of
      prolonged antibiotics is common in this setting. The investigators believe tedizolid
      addresses the unmet need for an oral antibiotic that is well-tolerated and efficacious for
      use as a prolonged therapy for bone and joint infection.
    

Intervention name(s): Tedizolid
Intervention type(s): Drug
Intervention description(s): 200mg oral tedizolid one pill per day
Other intervention name(s): tedizolid phosphate; Sivextro
Intervention MeSH terms: Tedizolid; Tedizolid phosphate; Oxazolidinones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone and joint infection; osteomyelitis; tedizolid