NCT00685698已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 15
- 主要终点
- Clinical Success (in ITT Population)
研究概览
简要总结
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nemonoxacin
Other
Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
干预措施: TG-873870 (Nemonoxacin) (Drug)
结局指标
主要结局
Clinical Success (in ITT Population)
时间窗: 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.
次要结局
- Microbiological Success Rate(Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination)
- Clinical Success (in PP Population)(Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination)
- Clinical Success (at End of Treatment/Early Termination)(End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1))
- Per-Pathogen Clinical Responses (at Test of Cure)(Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination)
- Total Wound Score (at End of Treatment/ Early Termination in ITT Population)(Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1))
- Per-Pathogen Clinical Response (at End of Treatment/Early Termination)(End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1))
- Per-Pathogen Microbiological Responses(Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination)
- Total Wound Score (at Test of Cure in ITT Population)(Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination)
- Total Wound Score (at Test of Cure in PP Population)(Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination)
- Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population(End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1))
- Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population(Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination)
- Total Wound Score (at End of Treatment/ Early Termination in PP Population)(Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1))
- Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)(Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination)
- Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population(End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1))
- Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population(Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination)
- Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)(Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination)
研究者
研究点 (15)
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