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

Community-Acquired Pneumonia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434291
• Other study ID #: TG-873870-02
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2007
• Last updated: November 23, 2009
• Start date: December 2006
• Est. completion date: August 2007

Study information

• Verified date: November 2009
• Source: TaiGen Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-Acquired Pneumonia
• Pneumonia

Intervention

Drug:
• TG-873870(Nemonoxacin)

Locations

Country	Name	City	State
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	GCT at Jubilee Hospital	Temba	North West
South Africa	Park Medical Centre	Witbank
Taiwan	Chang-Hua Christian Hospital	Changhua
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	Kaoshiung Medical University Hospital	Kaoshiung
Taiwan	Cheng Ching Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi-Mei Foundation Hospital	Tainan
Taiwan	Buddhist Taipei Tzu Chi General Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang-Gung Memorial Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
TaiGen Biotechnology Co., Ltd.	Quintiles, Inc.

Countries where clinical trial is conducted

South Africa,  Taiwan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety evaluation
Primary	Clinical Cure Rate
Secondary	Bacteriologic Cure Rate

External Links

•   NCBI