Diabetic Foot Infections Clinical Trial
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
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | June 2009 |
| Est. primary completion date | April 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| South Africa | Eastmed Academic Clinical Trial Center | East Lynne | Gauteng |
| South Africa | Jubilee Clinical Trial Center | Hammanskraal | Gauteng |
| South Africa | Mercantile Clinical Trial Center | Korsten | Port Elizabeth |
| South Africa | Montana Hospital | Pretoria | Gauteng |
| South Africa | Park Medical Center | Witbank | Gauteng |
| Taiwan | Chang Gung Memorial Hospital- Kaoshiung, Taiwan | Kaoshiung | |
| Taiwan | Cheng Ching Hospital, Taichung, Taiwan | Taichung | |
| Taiwan | Chi-Mei Medical Center, Tainan, Taiwan | Tainan | |
| Taiwan | Cardinal Tien Hospital (CTH), Taiwan | Taipei | |
| Taiwan | Tri-Service General Hospital, Taipei, Taiwan | Taipei | |
| Taiwan | Wan Fang Hospital | Taipei | |
| Taiwan | Cheng-Gung Memorial Hospital - LinKou, Taiwan | Tao Yuan | |
| Thailand | Faculty of Medicine, Khon Kaen University | Khon Kaen | |
| United States | The Amputation Prevention Center at Broadlawns Medical Center | Des Moines | Iowa |
| United States | HealthCare Partners | Montebello | California |
| United States | HealthCare Partners | Pasadena | California |
| Lead Sponsor | Collaborator |
|---|---|
| TaiGen Biotechnology Co., Ltd. |
United States, South Africa, Taiwan, Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical Success (in ITT Population) | 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. |
Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination | No |
| Secondary | Microbiological Success Rate | 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 |
Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination | No |
| Secondary | Clinical Success (in PP Population) | 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. |
Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination | No |
| Secondary | Clinical Success (at End of Treatment/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. |
End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1) | No |
| Secondary | Per-Pathogen Clinical Responses (at Test of Cure) | 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. | Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination | No |
| Secondary | Per-Pathogen Clinical Response (at End of Treatment/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 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. | End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1) | No |
| Secondary | Per-Pathogen Microbiological Responses | 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. | Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination | No |
| Secondary | Total Wound Score (at Test of Cure in ITT Population) | 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. | Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination | No |
| Secondary | Total Wound Score (at Test of Cure in PP Population) | 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. | Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination | No |
| Secondary | Total Wound Score (at End of Treatment/ Early Termination in ITT Population) | The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and End of Treatment/ Early Termination 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. | Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1) | No |
| Secondary | Total Wound Score (at End of Treatment/ Early Termination in PP Population) | 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. | Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1) | No |
| Secondary | Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population | The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and 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) | No |
| Secondary | Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population | The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure. | Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination | No |
| Secondary | Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population | The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and 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) | No |
| Secondary | Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population | The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure. | Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination | No |
| Secondary | Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population) | Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy 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) | No |
| Secondary | Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population) | Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure. | Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination | No |
| Secondary | Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population) | Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy 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) | No |
| Secondary | Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population) | Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure. | Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination | No |
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