Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
Condition: Diabetic Foot Infections
MeSH terms: Infections; Communicable Diseases; Focal Infection; Diabetic Foot
Intervention: TG-873870 (Nemonoxacin)
Intervention description: 750 mg
Intervention MeSH terms: Nemonoxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Foot Infections, DFI, Nemonoxacin

Summary:

      Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight ≥ 40 kg

          -  Previously known or newly diagnosed diabetes mellitus, including type 1 and type 2
             (per the American Diabetes Association guidelines), which is controlled by proper
             lifestyle (diet, exercise) or treatment with either oral medications or insulin

          -  Patients' HbA1c ≦ 12% at screening

          -  Clinically defined diabetic foot infection of mild or moderate severity (PEDIS grade
             2-3) as based on the guideline of the Infectious Diseases Society of America. It
             includes any inframalleolar infection of the soft-tissue, such as paronychia,
             cellulitis, myositis, abscesses, and tendonitis

          -  Evidence of necrotic tissue, purulent collections or abscess that may require
             excision, incision or drainage (based on investigator's judgment, and a surgeon if
             needed)

          -  Must be able to provide suitable tissue specimens (preferably obtained by biopsy or
             tissue curettage, or purulent fluid aspiration, rather than by swabbing) from the
             infected wound (after appropriate cleansing and debridement) for Gram-staining and
             bacterial cultures (aerobes and anaerobes)

          -  A confirmed Gram-positive pathogen infection by Gram-stain. The criterion to determine
             patient's eligibility for study recruitment is a Gram-stained smear with at least 1
             Gram-positive organism seen in at least two high power fields. A solely Gram-positive
             pathogen infection or a polymicrobial infection including Gram-positive and
             Gram-negative pathogens are acceptable within the framework of the study

        Exclusion Criteria:

          -  A co-morbid disease condition that could compromise evaluation or participation in
             this study, such as severe hepatic disease (e.g., active hepatitis, decompensated
             liver cirrhosis), renal failure (estimated creatinine clearance [CrCl] <30 ml/minute
             or need for hemodialysis or peritoneal dialysis), or active systemic malignancy
             (advanced or metastatic), unless enrollment is deemed appropriate at the discretion of
             the Investigator with prior consultation with the study Medical Monitor

          -  History of prolonged QTc interval or a medical condition requiring the use of a
             concomitant medication that is associated with an increased QTc interval (e.g., class
             I or class III anti-arrhythmic agents)

          -  Contact dermatitis over the infected skin area, infected third-degree burn wounds,
             necrotizing fascitis, extensive gangrene, pyoderma gangrenosum, deep vein thrombosis,
             shock, or any medical disorder that could either interfere with the evaluation of
             treatment or the response of the patient to therapy

          -  Radiological evidence of bone or joints infection within 7 days prior to or at
             screening, i.e. potential osteomyelitis or septic arthritis

          -  Clinically defined uninfected or severe infection (PEDIS grade 1 or 4) as based on the
             Infectious Diseases Society of America classification system

          -  Any known severe immunosuppressive condition, such as an active hematological
             malignancy, HIV infection or active treatment with any immunosuppressive drug
             (including corticosteroids at a dose of >20 mg/day of prednisone, or its equivalent)

          -  Has received or will be receiving chemotherapy or oncolytics within six months prior
             to entering or during the study

          -  History of current or active alcohol abuse (>3 drinks daily or binge drinking) or any
             illicit drug use

          -  Known or suspected critical ischemia of the affected limb (based on investigators'
             clinical judgments and vascular assessment)

          -  Wound that contains or is proximate to any prosthetic materials or devices that is/are
             not scheduled for removal

          -  Patient with a foot infection that, in the investigator's judgment, is severe enough
             to require hospitalization or intravenous antibiotic therapy

          -  Neutrophil count <1000 cells/mm3