Safety and Efficacy Comparison of TG-873870(Nemonoxacin) to Levofloxacin in Community-Acquired Pneumonia

Condition(s) targeted: Community-Acquired Pneumonia

Intervention: TG-873870(Nemonoxacin) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: TaiGen Biotechnology Co., Ltd.

Official(s) and/or principal investigator(s):
Reury-Perng Perng, Doctor, Principal Investigator, Affiliation: Taipei Veterans General Hospital, Taipei, Taiwan
Ming-Lin Ho, Doctor, Principal Investigator, Affiliation: Chang-Hua Christian Hospital, Changhua, Taiwan
Wann-Cherng Perng, Doctor, Principal Investigator, Affiliation: Tri-Service General Hospital, Taipei, Taiwan
Kai-Ming Chang, Doctor, Principal Investigator, Affiliation: Taichung Veterans General Hospital, Taichung, Taiwan
Yen-Hsu Chen, Doctor, Principal Investigator, Affiliation: Kaoshiung Medical University Hospital, Kaoshiung, Taiwan
Ren-Guang Wu, Doctor, Principal Investigator, Affiliation: Cheng Ching Hospital, Taichung, Taiwan
Yin-Ching Chuang, Doctor, Principal Investigator, Affiliation: Chi-Mei Foundation Hospital, Tainan, Taiwan
Horng-Chyuan Lin, Doctor, Principal Investigator, Affiliation: Chang-Gung Memorial Hospital, Taoyuan, Taiwan
Yao-Kuang Wu, Doctor, Principal Investigator, Affiliation: Buddhist Taipei Tzu Chi General Hospital, Taipei, Taiwan
Hsi-Hsun Lin, Doctor, Principal Investigator, Affiliation: E-Da Hospital, Kaohsiung, Taiwan
AJ Bester, Doctor, Principal Investigator, Affiliation: GCT at Jubilee Hospital, RSA
J Breedt, Doctor, Principal Investigator, Affiliation: Bougainville Hospital, RSA
CT de Villiers, Doctor, Principal Investigator, Affiliation: de Villers Clinical Trials, RSA
M Gani, Doctor, Principal Investigator, Affiliation: GCT Trial Centre, Mercantile Hospital, RSA
Y Kelfkens, Doctor, Principal Investigator, Affiliation: Private, RSA
DJ Jansen van Rensburg, Doctor, Principal Investigator, Affiliation: Park Medical Centre, RSA
J Jurgens, Doctor, Principal Investigator, Affiliation: DJW Research, RSA
IH Mitha, Doctor, Principal Investigator, Affiliation: Benmed/Pentagon Hospital, RSA
JH Mynhardt, Doctor, Principal Investigator, Affiliation: Private, RSA
G Nieuwoudt, Doctor, Principal Investigator, Affiliation: MediTrials, RSA
J Kasumba, Doctor, Principal Investigator, Affiliation: JOSHA Research, RSA
E van Nieuwenhuizen, Doctor, Principal Investigator, Affiliation: Eastmed Clinical Trial Center, RSA
CJJ van Rensburg, Doctor, Principal Investigator, Affiliation: Private, RSA

This study will test the safety and efficacy of TG-873870(Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia(CAP)

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)

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Safety evaluation

Clinical Cure Rate

Secondary outcome: Bacteriologic Cure Rate

Detailed description: 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) .  

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control) Must be a suitable candidate for oral antibiotic therapy and must be able to swallow capsules intact Must have a clinical diagnosis of CAP based on clinical evidence Must have a chest radiograph demonstrating new or persistent/progressive infiltrates Must be able to produce sputum Exclusion Criteria: Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval Patients with CAP that, in the investigator's judgment, is severe enough to require hospitalization for intravenous antibiotic therapy and/or supplemental oxygen therapy with ICU support Known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease [COPD] is not exclusionary) Infection acquired in a hospital, nursing home, or other long-term care facility, or hospitalization for any reason within the previous 14 days Treatment with any antibiotics within the past 7 days prior to randomization, unless documents to be a treatment failure(72 hours treatment and not responding) Anticipation of the requirement for additional treatment with non-study antibacterials for any reason during the patient's participation in the study Treatment with chemotherapeutic agents or oncolytics during the 6 months prior to randomization or anticipated requirement for such agents during the course of the study Known or suspected CNS disorder that may predispose the patient to seizures or lower the seizure threshold

Bougainville Hospital, Pretoria, South Africa

de Villers Clinical Trials, Scottburgh, South Africa

GCT Trial Centre, Mercantile Hospital, Port Elizabeth, South Africa

Private, Potchefstroom, South Africa

Park Medical Centre, Witbank, South Africa

DJW Research, Krugersdorp, South Africa

Benmed/Pentagon Hospital, Benomi, South Africa

Private, Kimberley, South Africa

MediTrials, Cape Town, South Africa

Taipei Veterans General Hospital, Taipei 114, Taiwan

Chang-Hua Christian Hospital, Changhua 114, Taiwan

Tri-Service General Hospital, Taipei 114, Taiwan

Taichung Veterans General Hospital, Taichung 114, Taiwan

Kaoshiung Medical University Hospital, Kaoshiung 114, Taiwan

Cheng Ching Hospital, Taichung 114, Taiwan

Chi-Mei Foundation Hospital, Tainan 114, Taiwan

Chang-Gung Memorial Hospital, Taoyuan 114, Taiwan

Buddhist Taipei Tzu Chi General Hospital, Taipei 114, Taiwan

E-Da Hospital, Kaohsiung 114, Taiwan

GCT at Jubilee Hospital, Temba, North West, South Africa

NCBI

Related publications:

Bartlett JG, Breiman RF, Mandell LA, File TM Jr. Community-acquired pneumonia in adults: guidelines for management. The Infectious Diseases Society of America. Clin Infect Dis. 1998 Apr;26(4):811-38.

Mandell LA, Bartlett JG, Dowell SF, File TM Jr, Musher DM, Whitney C; Infectious Diseases Society of America. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. 2003 Dec 1;37(11):1405-33. Epub 2003 Nov 3. No abstract available.

Bartlett JG, Dowell SF, Mandell LA, File Jr TM, Musher DM, Fine MJ. Practice guidelines for the management of community-acquired pneumonia in adults. Infectious Diseases Society of America. Clin Infect Dis. 2000 Aug;31(2):347-82. Epub 2000 Sep 7. No abstract available.

Fujimoto T, Mitsuhashi S. In vitro antibacterial activity of DR-3355, the S-(-)-isomer of ofloxacin. Chemotherapy. 1990;36(4):268-76.

Croom KF, Goa KL. Levofloxacin: a review of its use in the treatment of bacterial infections in the United States. Drugs. 2003;63(24):2769-802. Review.

Ellner PD, Neu HC. The inhibitory quotient. A method for interpreting minimum inhibitory concentration data. JAMA. 1981 Oct 2;246(14):1575-8.

Starting date: December 2006
Ending date: August 2007
Last updated: October 1, 2007