Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
This study will assess the safety and efficacy of TG-873870 (Nemonoxacin) in patients with
 Diabetic Foot Infections. Pharmacokinetic (PK) and pharmacodynamic (PD) assessment will be
 conducted in a subgroup of eight consenting patients.
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