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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label, Single-Arm, Multi-Center Study of TG-873870 for Treating Patients With Diabetic Foot Infections of Mild to Moderate Severity Associated With Gram-Positive Pathogens

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

Detailed Summary: 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.
Sponsor: TaiGen Biotechnology Co., Ltd.

Current Primary Outcome: Clinical Success (in ITT Population) [ Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination ]

Clinical Success

  • Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.
  • Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions.


Original Primary Outcome:

Current Secondary Outcome:

  • Microbiological Success Rate [ Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination ]

    Microbiological Success

    • Eradicated, defined as absence of the original pathogen(s) from a repeat culture of the original infection site performed at the TOC visit.

    • Presumed Eradicated, defined as meeting the definition for Clinical Success at the TOC visit, but tissue sample could be obtained for culture from the original infection site.

      • TOC=Test of Cure
  • Clinical Success (in PP Population) [ Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination ]

    Clinical Success

    • Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.
    • Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions.
  • Clinical Success (at End of Treatment/Early Termination) [ Time Frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1) ]

    Clinical Success

    • Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.
    • Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions.
  • Per-Pathogen Clinical Responses (at Test of Cure) [ Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination ]
    Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.
  • Per-Pathogen Clinical Response (at End of Treatment/Early Termination) [ Time Frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1) ]
    Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at at End of Treatment/Early Termination within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.
  • Per-Pathogen Microbiological Responses [ Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination ]
    Microbiological responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Microbiological Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Microbiological Success rates for Streptococcus pyogenes in the PP population.
  • Total Wound Score (at Test of Cure in ITT Population) [ Time Frame: Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination ]
    The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.
  • Total Wound Score (at Test of Cure in PP Population) [ Time Frame: Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination ]
    The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of C

    Original Secondary Outcome:

    • Safety Evaluation
    • Microbiological Success Rate
    • PK and PD Evaluation


    Information By: TaiGen Biotechnology Co., Ltd.

    Dates:
    Date Received: May 22, 2008
    Date Started: June 2008
    Date Completion:
    Last Updated: December 25, 2014
    Last Verified: December 2014