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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00685698
First received: May 22, 2008
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Diabetic Foot Infections
Drug: TG-873870 (Nemonoxacin)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by TaiGen Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • Clinical Success [ Time Frame: end-of-treatment visit and follow-up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Evaluation [ Time Frame: during the study period (from baseline visit to follow-up visit) ] [ Designated as safety issue: Yes ]
  • Microbiological Success Rate [ Time Frame: follow-up visit ] [ Designated as safety issue: No ]
  • PK and PD Evaluation [ Time Frame: day 7 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nemonoxacin
Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.
Drug: TG-873870 (Nemonoxacin)
750 mg

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685698

Locations
United States, California
HealthCare Partners
Montebello, California, United States, 90640
HealthCare Partners
Pasadena, California, United States, 91105
United States, Iowa
The Amputation Prevention Center at Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
South Africa
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
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, Taiwan
Thailand
Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
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
  More Information

No publications provided

Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT00685698     History of Changes
Other Study ID Numbers: TG-873870-04
Study First Received: May 22, 2008
Last Updated: November 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by TaiGen Biotechnology Co., Ltd.:
Diabetic Foot Infections, DFI, Nemonoxacin

Additional relevant MeSH terms:
Diabetic Foot
Focal Infection
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Infection

ClinicalTrials.gov processed this record on August 19, 2014