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| Sponsor: | TaiGen Biotechnology Co., Ltd. |
|---|---|
| Collaborator: |
Quintiles |
| Information provided by: | TaiGen Biotechnology Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00434291 |
Purpose
This study will test the safety and efficacy of TG-873870(Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia(CAP)
| Condition | Intervention | Phase |
|---|---|---|
|
Community-Acquired Pneumonia |
Drug: TG-873870(Nemonoxacin) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Comparative, Multi-Center Study of the Safety and Efficacy of TG-873870(Nemonoxacin) Versus Levofloxacin in Adult Patients With Community-Acquired Pneumonia (CAP) |
| Estimated Enrollment: | 264 |
| Study Start Date: | December 2006 |
| Study Completion Date: | August 2007 |
Community-acquired Pneumonia(CAP) remains a leading cause of death in both developing and developed countries. In the choice of antibacterial agents used to treat CAP, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity. TG-873870(Nemonoxacin), a non-fluorinated quinolone (NFQ), is a selective bacterial topoisomerase inhibitor. This study will test the safety and efficacy of TG-873870(Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia (CAP) .
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| South Africa | |
| GCT at Jubilee Hospital | |
| Temba, North West, South Africa | |
| Benmed/Pentagon Hospital | |
| Benomi, South Africa | |
| MediTrials | |
| Cape Town, South Africa | |
| Private | |
| Kimberley, South Africa | |
| DJW Research | |
| Krugersdorp, South Africa | |
| GCT Trial Centre, Mercantile Hospital | |
| Port Elizabeth, South Africa | |
| Private | |
| Potchefstroom, South Africa | |
| Bougainville Hospital | |
| Pretoria, South Africa | |
| de Villers Clinical Trials | |
| Scottburgh, South Africa | |
| Park Medical Centre | |
| Witbank, South Africa | |
| Taiwan | |
| Chang-Hua Christian Hospital | |
| Changhua, Taiwan, 114 | |
| E-Da Hospital | |
| Kaohsiung, Taiwan, 114 | |
| Kaoshiung Medical University Hospital | |
| Kaoshiung, Taiwan, 114 | |
| Taichung Veterans General Hospital | |
| Taichung, Taiwan, 114 | |
| Cheng Ching Hospital | |
| Taichung, Taiwan, 114 | |
| Chi-Mei Foundation Hospital | |
| Tainan, Taiwan, 114 | |
| Tri-Service General Hospital | |
| Taipei, Taiwan, 114 | |
| Taipei Veterans General Hospital | |
| Taipei, Taiwan, 114 | |
| Buddhist Taipei Tzu Chi General Hospital | |
| Taipei, Taiwan, 114 | |
| Chang-Gung Memorial Hospital | |
| Taoyuan, Taiwan, 114 | |
| Principal Investigator: | Reury-Perng Perng, Doctor | Taipei Veterans General Hospital, Taipei, Taiwan |
| Principal Investigator: | Ming-Lin Ho, Doctor | Chang-Hua Christian Hospital, Changhua, Taiwan |
| Principal Investigator: | Wann-Cherng Perng, Doctor | Tri-Service General Hospital, Taipei, Taiwan |
| Principal Investigator: | Kai-Ming Chang, Doctor | Taichung Veterans General Hospital, Taichung, Taiwan |
| Principal Investigator: | Yen-Hsu Chen, Doctor | Kaoshiung Medical University Hospital, Kaoshiung, Taiwan |
| Principal Investigator: | Ren-Guang Wu, Doctor | Cheng Ching Hospital, Taichung, Taiwan |
| Principal Investigator: | Yin-Ching Chuang, Doctor | Chi-Mei Foundation Hospital, Tainan, Taiwan |
| Principal Investigator: | Horng-Chyuan Lin, Doctor | Chang-Gung Memorial Hospital, Taoyuan, Taiwan |
| Principal Investigator: | Yao-Kuang Wu, Doctor | Buddhist Taipei Tzu Chi General Hospital, Taipei, Taiwan |
| Principal Investigator: | Hsi-Hsun Lin, Doctor | E-Da Hospital, Kaohsiung, Taiwan |
| Principal Investigator: | AJ Bester, Doctor | GCT at Jubilee Hospital, RSA |
| Principal Investigator: | J Breedt, Doctor | Bougainville Hospital, RSA |
| Principal Investigator: | CT de Villiers, Doctor | de Villers Clinical Trials, RSA |
| Principal Investigator: | M Gani, Doctor | GCT Trial Centre, Mercantile Hospital, RSA |
| Principal Investigator: | Y Kelfkens, Doctor | Private, RSA |
| Principal Investigator: | DJ Jansen van Rensburg, Doctor | Park Medical Centre, RSA |
| Principal Investigator: | J Jurgens, Doctor | DJW Research, RSA |
| Principal Investigator: | IH Mitha, Doctor | Benmed/Pentagon Hospital, RSA |
| Principal Investigator: | JH Mynhardt, Doctor | Private, RSA |
| Principal Investigator: | G Nieuwoudt, Doctor | MediTrials, RSA |
| Principal Investigator: | J Kasumba, Doctor | JOSHA Research, RSA |
| Principal Investigator: | E van Nieuwenhuizen, Doctor | Eastmed Clinical Trial Center, RSA |
| Principal Investigator: | CJJ van Rensburg, Doctor | Private, RSA |
More Information
| ClinicalTrials.gov Identifier: | NCT00434291 History of Changes |
| Other Study ID Numbers: | TG-873870-02 |
| Study First Received: | February 12, 2007 |
| Last Updated: | November 23, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Community-acquired Pneumonia fluoroquinolone TG-873870 Nemonoxacin |
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Ofloxacin Anti-Bacterial Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |