Clinical trial NCT00685698: Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Infections
Keywords: Diabetic Foot Infections, DFI, Nemonoxacin
Lead sponsor: TaiGen Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Success (in ITT Population)
timeFrame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Secondary outcomes:
measure: Microbiological Success Rate
timeFrame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
measure: Clinical Success (in PP Population)
timeFrame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
measure: Clinical Success (at End of Treatment/Early Termination)
timeFrame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
measure: Per-Pathogen Clinical Responses (at Test of Cure)
timeFrame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
measure: Per-Pathogen Clinical Response (at End of Treatment/Early Termination)
timeFrame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
measure: Per-Pathogen Microbiological Responses
timeFrame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
measure: Total Wound Score (at Test of Cure in ITT Population)
timeFrame: Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
measure: Total Wound Score (at Test of Cure in PP Population)
timeFrame: Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
measure: Total Wound Score (at End of Treatment/ Early Termination in ITT Population)
timeFrame: Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
measure: Total Wound Score (at End of Treatment/ Early Termination in PP Population)
timeFrame: Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
measure: Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population
timeFrame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
measure: Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population
timeFrame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
measure: Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population
timeFrame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
measure: Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population
timeFrame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
measure: Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)
timeFrame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
measure: Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)
timeFrame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
measure: Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)
timeFrame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
measure: Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)
timeFrame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Other outcomes:
Locations:
city: Montebello
country: United States
facility: HealthCare Partners
state: California
city: Pasadena
country: United States
facility: HealthCare Partners
state: California
city: Des Moines
country: United States
facility: The Amputation Prevention Center at Broadlawns Medical Center
state: Iowa
city: East Lynne
country: South Africa
facility: Eastmed Academic Clinical Trial Center
state: Gauteng
city: Hammanskraal
country: South Africa
facility: Jubilee Clinical Trial Center
state: Gauteng
city: Pretoria
country: South Africa
facility: Montana Hospital
state: Gauteng
city: Witbank
country: South Africa
facility: Park Medical Center
state: Gauteng
city: Korsten
country: South Africa
facility: Mercantile Clinical Trial Center
state: Port Elizabeth
city: Kaoshiung
country: Taiwan
facility: Chang Gung Memorial Hospital- Kaoshiung, Taiwan
city: Taichung
country: Taiwan
facility: Cheng Ching Hospital, Taichung, Taiwan
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Center, Tainan, Taiwan
city: Taipei
country: Taiwan
facility: Cardinal Tien Hospital (CTH), Taiwan
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, Taipei, Taiwan
city: Taipei
country: Taiwan
facility: Wan Fang Hospital
city: Tao Yuan
country: Taiwan
facility: Cheng-Gung Memorial Hospital - LinKou, Taiwan
city: Khon Kaen
country: Thailand
facility: Faculty of Medicine, Khon Kaen University
Study officials:
affiliation: Tri-Service General Hospital, Taipei, Taiwan
name: Kuang-Chung Shih, M.D.
role: STUDY_CHAIR
affiliation: Cheng-Gung Memorial Hospital - LinKou, Taiwan
name: Jawl-Shan Hwang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardinal Tien Hospital (CTH), Taiwan
name: Te-Lin Hsia, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital- Kaoshiung, Taiwan
name: Jung-Fu Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chi-Mei Medical Center, Tainan, Taiwan
name: Chien-Wen Chou, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cheng Ching Hospital, Taichung, Taiwan
name: Che-Han Hsu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: HealthCare Partners, Pasadena, USA
name: Joseph De Santo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Amputation Prevention Center at Broadlawns Medical Center, Des Moines, USA
name: Lee Rogers, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: HealthCare Partners, Montebello, USA
name: Kwei Quartey, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Montana Hospital, Pretoria, South Africa
name: Lynn Tudhope, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jubilee Clinical Trial Center, Hammanskraal, South Africa
name: Andre Tudhope, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastmed Academic Clinical Trial Center, East Lynne, South Africa
name: Mohammed Fulat, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Park Medical Center, Witbank, South Africa
name: Dirkie van Rensburg, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercantile Clinical Trial Center, Korsten, South Africa
name: Mashra Gani, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Khon Kaen University, Thailand
name: Piroon Mootsitkapun, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wan Fang Hospital, Taipei, Taiwan
name: Chieh-Feng Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: