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
Intervention: Tedizolid
Intervention description: 200mg oral tedizolid one pill per day
Intervention MeSH terms: Tedizolid; Tedizolid phosphate; Oxazolidinones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: bone and joint infection; osteomyelitis; tedizolid

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment of bone and joint infection in which therapy for Gram positive organisms is
             documented or suspected, as determined by the treating physician and treatment of at
             least 4 weeks is planned. Bone and joint infection and trauma-associated bone and
             joint infection will defined clinically using radiologic (e.g., MRI) and/or surgical
             (e.g., intra-operative findings) definitions. All subjects must have confirmation
             (diagnosis mentioned in chart) by the patient's primary physician and consultants that
             the patients has or likely has bone and joint infection and requires prolonged
             antibiotic therapy.

          -  Aged between 18 years and 85 years.

          -  Plans to treat bone and joint infection in outpatient setting.

          -  No limited planned course of antibiotics (i.e., no indefinite treatment plans for
             chronic suppression). Co-administration of other antibiotics that target other
             causative or potentially causative organisms (e.g., fluoroquinolones) is acceptable.

          -  Able to come to the research clinic for study follow-up visits for the study period.

        Exclusion Criteria:

          -  Planned prolonged hospitalization (> 1 week).

          -  Pregnancy (all female subjects of childbearing age will be given a pregnancy test
             prior to enrollment) or breast feeding. If a women is of childbearing potential, she
             must consistently use an acceptable method of contraception (IUD, injectable
             contraceptive, birth control patch, OCP, barrier method, abstinence) from baseline
             through the course of antibiotics (4-12 weeks). If a male patient's sexual partner is
             of childbearing potential, the male patient must acknowledge that they will
             consistently use an acceptable method of contraception as defined above from baseline
             through the course of antibiotics (4-12 weeks).

          -  Comorbidities that, in the opinion of the investigator, are uncontrolled (e.g.,
             diabetes, hypertension, psychiatric disease).

          -  Peripheral or optic neuropathy.

          -  Underlying hematologic cytopenias (e.g., baseline thrombocytopenia, or severe anemia,
             or leukopenia) as determined by the following limits from a baseline CBC/CMP obtained
             within the past 14 days. Note that if a CBC has not been performed within the past 14
             days, a CBC will be performed on the day of enrollment prior to any study drug being
             administered to ensure the patient does not meet exclusion criteria. Cytopenias are
             defined as:

               1. Hemoglobin (Hgb) < 8.0g/dL

               2. WBC < 4,000 k/cumm

               3. Platelets < 150,000 k/cumm

          -  Severe hepatic dysfunction as defined by liver function tests (ALT, ALP, AST, total
             bilirubin) > 3.0 times the upper limit of normal. as determined by the following
             limits from a baseline CMP obtained within the past 7 days. If a CMP has not been
             performed within the past 7 days, baseline levels may be used from a CMP performed
             within the past 2 months as long as another CMP is performed on the day of enrollment
             and the subject's levels are within the following limits.

          -  Hypersensitivity to tedizolid or other oxazolidinone-class antibiotics or similar
             compounds.

          -  Ongoing antibiotic-associated colitis.

          -  A diet high in tyramine-containing foods such as pickled or fermented meats and
             cheeses, wine, or avocados per investigator discretion.

          -  Concurrent use of sodium picosulfate (brand names: Sodipic Picofast, Laxoberal,
             Laxoberon, Purg-Odan, Picolax, Guttalax, Namilax, Pico-Salax and Prepopik).

          -  Previous participation in the study.

          -  Use of tedizolid for any condition in the past 3 months.

          -  Any other medical, psychological, or social condition that, in the opinion of the
             Investigator, would prevent the patient from fully participating in the study or would
             represent a concern for study compliance or constitute a safety concern to the
             patient.