- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00685698
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
December 25, 2014 updated by: TaiGen Biotechnology Co., Ltd.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gauteng
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East Lynne, Gauteng, South Africa
- Eastmed Academic Clinical Trial Center
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Hammanskraal, Gauteng, South Africa
- Jubilee Clinical Trial Center
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Pretoria, Gauteng, South Africa
- Montana Hospital
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Witbank, Gauteng, South Africa
- Park Medical Center
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Port Elizabeth
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Korsten, Port Elizabeth, South Africa
- Mercantile Clinical Trial Center
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Kaoshiung, Taiwan
- Chang Gung Memorial Hospital- Kaoshiung, Taiwan
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Taichung, Taiwan
- Cheng Ching Hospital, Taichung, Taiwan
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Tainan, Taiwan
- Chi-Mei Medical Center, Tainan, Taiwan
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Taipei, Taiwan
- Wan Fang Hospital
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Taipei, Taiwan
- Cardinal Tien Hospital (CTH), Taiwan
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Taipei, Taiwan
- Tri-Service General Hospital, Taipei, Taiwan
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Tao Yuan, Taiwan
- Cheng-Gung Memorial Hospital - LinKou, Taiwan
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Khon Kaen, Thailand
- Faculty of Medicine, Khon Kaen University
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California
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Montebello, California, United States, 90640
- Healthcare Partners
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Pasadena, California, United States, 91105
- Healthcare Partners
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Iowa
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Des Moines, Iowa, United States, 50314
- The Amputation Prevention Center at Broadlawns Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Nemonoxacin
Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
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750 mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Success (in ITT Population)
Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
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Clinical Success
|
Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiological Success Rate
Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
|
Microbiological Success
|
Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
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Clinical Success (in PP Population)
Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
|
Clinical Success
|
Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
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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)
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Clinical Success
|
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)
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.
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Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
|
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.
|
End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
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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.
|
Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
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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.
|
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)
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.
|
Visit 1 (Baseline); 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)
Time Frame: Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
|
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)
|
Total Wound Score (at End of Treatment/ Early Termination in PP Population)
Time Frame: Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
|
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)
|
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population
Time Frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
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The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.
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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
Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
|
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
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Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population
Time Frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
|
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)
|
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population
Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
|
The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.
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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 ITT Population)
Time Frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
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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.
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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)
Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
|
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
|
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)
Time Frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
|
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)
|
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)
Time Frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kuang-Chung Shih, M.D., Tri-Service General Hospital, Taipei, Taiwan
- Principal Investigator: Jawl-Shan Hwang, M.D., Cheng-Gung Memorial Hospital - LinKou, Taiwan
- Principal Investigator: Te-Lin Hsia, M.D., Cardinal Tien Hospital (CTH), Taiwan
- Principal Investigator: Jung-Fu Chen, M.D., Chang Gung Memorial Hospital- Kaoshiung, Taiwan
- Principal Investigator: Chien-Wen Chou, M.D., Chi-Mei Medical Center, Tainan, Taiwan
- Principal Investigator: Che-Han Hsu, M.D., Cheng Ching Hospital, Taichung, Taiwan
- Principal Investigator: Joseph De Santo, M.D., HealthCare Partners, Pasadena, USA
- Principal Investigator: Lee Rogers, M.D., The Amputation Prevention Center at Broadlawns Medical Center, Des Moines, USA
- Principal Investigator: Kwei Quartey, M.D., HealthCare Partners, Montebello, USA
- Principal Investigator: Lynn Tudhope, M.D., Montana Hospital, Pretoria, South Africa
- Principal Investigator: Andre Tudhope, M.D., Jubilee Clinical Trial Center, Hammanskraal, South Africa
- Principal Investigator: Mohammed Fulat, M.D., Eastmed Academic Clinical Trial Center, East Lynne, South Africa
- Principal Investigator: Dirkie van Rensburg, M.D., Park Medical Center, Witbank, South Africa
- Principal Investigator: Mashra Gani, M.D., Mercantile Clinical Trial Center, Korsten, South Africa
- Principal Investigator: Piroon Mootsitkapun, M.D., Faculty of Medicine, Khon Kaen University, Thailand
- Principal Investigator: Chieh-Feng Chen, M.D., Wan Fang Hospital, Taipei, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
May 22, 2008
First Submitted That Met QC Criteria
May 22, 2008
First Posted (Estimate)
May 28, 2008
Study Record Updates
Last Update Posted (Estimate)
January 9, 2015
Last Update Submitted That Met QC Criteria
December 25, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Disease Attributes
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Ulcer
- Diabetic Foot
- Infections
- Communicable Diseases
- Focal Infection
Other Study ID Numbers
- TG-873870-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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