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

NCT ID: NCT00685698

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-06-30

Brief Summary

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

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.

Conditions

Diabetic Foot Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nemonoxacin

Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.

Group Type: OTHER

TG-873870 (Nemonoxacin)

Intervention Type: DRUG

750 mg

Interventions

TG-873870 (Nemonoxacin)

750 mg

Intervention Type: DRUG

Other Intervention Names

Taigexyn

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TaiGen Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kuang-Chung Shih, M.D.

Role: STUDY_CHAIR

Tri-Service General Hospital, Taipei, Taiwan

Jawl-Shan Hwang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cheng-Gung Memorial Hospital - LinKou, Taiwan

Te-Lin Hsia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cardinal Tien Hospital (CTH), Taiwan

Jung-Fu Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital- Kaoshiung, Taiwan

Chien-Wen Chou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chi-Mei Medical Center, Tainan, Taiwan

Che-Han Hsu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cheng Ching Hospital, Taichung, Taiwan

Joseph De Santo, M.D.

Role: PRINCIPAL_INVESTIGATOR

HealthCare Partners, Pasadena, USA

Lee Rogers, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Amputation Prevention Center at Broadlawns Medical Center, Des Moines, USA

Kwei Quartey, M.D.

Role: PRINCIPAL_INVESTIGATOR

HealthCare Partners, Montebello, USA

Lynn Tudhope, M.D.

Role: PRINCIPAL_INVESTIGATOR

Montana Hospital, Pretoria, South Africa

Andre Tudhope, M.D.

Role: PRINCIPAL_INVESTIGATOR

Jubilee Clinical Trial Center, Hammanskraal, South Africa

Mohammed Fulat, M.D.

Role: PRINCIPAL_INVESTIGATOR

Eastmed Academic Clinical Trial Center, East Lynne, South Africa

Dirkie van Rensburg, M.D.

Role: PRINCIPAL_INVESTIGATOR

Park Medical Center, Witbank, South Africa

Mashra Gani, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mercantile Clinical Trial Center, Korsten, South Africa

Piroon Mootsitkapun, M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Khon Kaen University, Thailand

Chieh-Feng Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wan Fang Hospital, Taipei, Taiwan

Locations

HealthCare Partners

Montebello, California, United States

HealthCare Partners

Pasadena, California, United States

The Amputation Prevention Center at Broadlawns Medical Center

Des Moines, Iowa, United States

Eastmed Academic Clinical Trial Center

East Lynne, Gauteng, South Africa

Jubilee Clinical Trial Center

Hammanskraal, Gauteng, South Africa

Montana Hospital

Pretoria, Gauteng, South Africa

Park Medical Center

Witbank, Gauteng, South Africa

Mercantile Clinical Trial Center

Korsten, Port Elizabeth, South Africa

Chang Gung Memorial Hospital- Kaoshiung, Taiwan

Kaohsiung City, , Taiwan

Cheng Ching Hospital, Taichung, Taiwan

Taichung, , Taiwan

Chi-Mei Medical Center, Tainan, Taiwan

Tainan City, , 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

Taoyuan District, , Taiwan

Faculty of Medicine, Khon Kaen University

Khon Kaen, , Thailand

Countries

United States; South Africa; Taiwan; Thailand

Other Identifiers

TG-873870-04

Identifier Type: -

Identifier Source: org_study_id