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

NCT00685698 | Completed Phase 2 Results

• 1 other identifier: TG-873870-04
• Study Type: interventional
• Target: 40
• Locations: 4 countries
• Sites: 16

Brief Summary

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

Conditions

Diabetic Foot Infections

Keywords

Diabetic Foot Infections, DFI, Nemonoxacin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (18)

• 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

• 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)

Study Arms (1)

Nemonoxacin

OTHER

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

Drug: TG-873870 (Nemonoxacin)

Interventions

TG-873870 (Nemonoxacin) DRUG

750 mg

Also known as: Taigexyn

Nemonoxacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TaiGen Biotechnology Co., Ltd.: lead

Study Sites (16)

HealthCare Partners

Montebello, California, 90640, United States

Location

HealthCare Partners

Pasadena, California, 91105, United States

Location

The Amputation Prevention Center at Broadlawns Medical Center

Des Moines, Iowa, 50314, United States

Location

Eastmed Academic Clinical Trial Center

East Lynne, Gauteng, South Africa

Location

Jubilee Clinical Trial Center

Hammanskraal, Gauteng, South Africa

Location

Montana Hospital

Pretoria, Gauteng, South Africa

Location

Park Medical Center

Witbank, Gauteng, South Africa

Location

Mercantile Clinical Trial Center

Korsten, Port Elizabeth, South Africa

Location

Chang Gung Memorial Hospital- Kaoshiung, Taiwan

Kaohsiung City, Taiwan

Location

Cheng Ching Hospital, Taichung, Taiwan

Taichung, Taiwan

Location

Chi-Mei Medical Center, Tainan, Taiwan

Tainan, Taiwan

Location

Cardinal Tien Hospital (CTH), Taiwan

Taipei, Taiwan

Location

Tri-Service General Hospital, Taipei, Taiwan

Taipei, Taiwan

Location

Wan Fang Hospital

Taipei, Taiwan

Location

Cheng-Gung Memorial Hospital - LinKou, Taiwan

Taoyuan District, Taiwan

Location

Faculty of Medicine, Khon Kaen University

Khon Kaen, Thailand

Location

MeSH Terms

Interventions

nemonoxacin

Results Point of Contact

• Title: Chen-En Tsai, M.D., Ph.D.
• Organization: TaiGen Biotechnology Co., Ltd.

cetsai@taigenbiotech.com

+886-2-8177-7072

Study Officials

• Kuang-Chung Shih, M.D.

  Tri-Service General Hospital, Taipei, Taiwan

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 28, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 1, 2025
• Results First Posted: January 9, 2015

Record last verified: 2014-12

Locations

TH (1); US (3); TW (7); ZA (5)