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

NCT00434291 | Completed Phase 2

• 1 other identifier: TG-873870-02
• Study Type: interventional
• Target: 264
• Locations: 2 countries
• Sites: 20

Brief Summary

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

Conditions

Community-Acquired Pneumonia

Keywords

Community-acquired Pneumonia; fluoroquinolone; TG-873870; Nemonoxacin

Outcome Measures

Primary Outcomes (2)

• Safety evaluation

• Clinical Cure Rate

Secondary Outcomes (1)

• Bacteriologic Cure Rate

Interventions

TG-873870(Nemonoxacin) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• TaiGen Biotechnology Co., Ltd.: lead
• Quintiles, Inc.: collaborator

Study Sites (20)

GCT at Jubilee Hospital

Temba, North West, South Africa

Location

Benmed/Pentagon Hospital

Benomi, South Africa

Location

MediTrials

Cape Town, South Africa

Location

Private

Kimberley, South Africa

Location

DJW Research

Krugersdorp, South Africa

Location

GCT Trial Centre, Mercantile Hospital

Port Elizabeth, South Africa

Location

Private

Potchefstroom, South Africa

Location

Bougainville Hospital

Pretoria, South Africa

Location

de Villers Clinical Trials

Scottburgh, South Africa

Location

Park Medical Centre

Witbank, South Africa

Location

Chang-Hua Christian Hospital

Changhua, 114, Taiwan

Location

E-Da Hospital

Kaohsiung City, 114, Taiwan

Location

Kaoshiung Medical University Hospital

Kaoshiung, 114, Taiwan

Location

Cheng Ching Hospital

Taichung, 114, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 114, Taiwan

Location

Chi-Mei Foundation Hospital

Tainan, 114, Taiwan

Location

Buddhist Taipei Tzu Chi General Hospital

Taipei, 114, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 114, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Chang-Gung Memorial Hospital

Taoyuan District, 114, Taiwan

Location

Related 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. doi: 10.1086/513953.

  PMID: 9564457 BACKGROUND

• 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. doi: 10.1086/380488. Epub 2003 Nov 3. No abstract available.

  PMID: 14614663 BACKGROUND

• Bartlett JG, Dowell SF, Mandell LA, File TM Jr, 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. doi: 10.1086/313954. Epub 2000 Sep 7. No abstract available.

  PMID: 10987697 BACKGROUND

• Fujimoto T, Mitsuhashi S. In vitro antibacterial activity of DR-3355, the S-(-)-isomer of ofloxacin. Chemotherapy. 1990;36(4):268-76. doi: 10.1159/000238777.

  PMID: 2174762 BACKGROUND

• 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. doi: 10.2165/00003495-200363240-00008.

  PMID: 14664657 BACKGROUND

• Ellner PD, Neu HC. The inhibitory quotient. A method for interpreting minimum inhibitory concentration data. JAMA. 1981 Oct 2;246(14):1575-8. doi: 10.1001/jama.246.14.1575.

  PMID: 7277631 BACKGROUND

Related Links

• NCBI

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

nemonoxacin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 12, 2007
• First Posted: February 13, 2007
• Study Start: December 1, 2006
• Study Completion: August 1, 2007
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

ZA (10); TW (10)