Safety and Efficacy Comparison of TG-873870(Nemonoxacin) to Levofloxacin in Community-Acquired Pneumonia
NCT ID: NCT00434291
Last Updated: 2009-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
264 participants
INTERVENTIONAL
2006-12-31
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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TG-873870(Nemonoxacin)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Quintiles, Inc.
INDUSTRY
TaiGen Biotechnology Co., Ltd.
INDUSTRY
Principal Investigators
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Reury-Perng Perng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taipei, Taiwan
Ming-Lin Ho, Doctor
Role: PRINCIPAL_INVESTIGATOR
Chang-Hua Christian Hospital, Changhua, Taiwan
Wann-Cherng Perng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Tri-Service General Hospital, Taipei, Taiwan
Kai-Ming Chang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Taichung Veterans General Hospital, Taichung, Taiwan
Yen-Hsu Chen, Doctor
Role: PRINCIPAL_INVESTIGATOR
Kaoshiung Medical University Hospital, Kaoshiung, Taiwan
Ren-Guang Wu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Cheng Ching Hospital, Taichung, Taiwan
Yin-Ching Chuang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Chi-Mei Foundation Hospital, Tainan, Taiwan
Horng-Chyuan Lin, Doctor
Role: PRINCIPAL_INVESTIGATOR
Chang-Gung Memorial Hospital, Taoyuan, Taiwan
Yao-Kuang Wu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Buddhist Taipei Tzu Chi General Hospital, Taipei, Taiwan
Hsi-Hsun Lin, Doctor
Role: PRINCIPAL_INVESTIGATOR
E-Da Hospital, Kaohsiung, Taiwan
AJ Bester, Doctor
Role: PRINCIPAL_INVESTIGATOR
GCT at Jubilee Hospital, RSA
J Breedt, Doctor
Role: PRINCIPAL_INVESTIGATOR
Bougainville Hospital, RSA
CT de Villiers, Doctor
Role: PRINCIPAL_INVESTIGATOR
de Villers Clinical Trials, RSA
M Gani, Doctor
Role: PRINCIPAL_INVESTIGATOR
GCT Trial Centre, Mercantile Hospital, RSA
Y Kelfkens, Doctor
Role: PRINCIPAL_INVESTIGATOR
Private, RSA
DJ Jansen van Rensburg, Doctor
Role: PRINCIPAL_INVESTIGATOR
Park Medical Centre, RSA
J Jurgens, Doctor
Role: PRINCIPAL_INVESTIGATOR
DJW Research, RSA
IH Mitha, Doctor
Role: PRINCIPAL_INVESTIGATOR
Benmed/Pentagon Hospital, RSA
JH Mynhardt, Doctor
Role: PRINCIPAL_INVESTIGATOR
Private, RSA
G Nieuwoudt, Doctor
Role: PRINCIPAL_INVESTIGATOR
MediTrials, RSA
J Kasumba, Doctor
Role: PRINCIPAL_INVESTIGATOR
JOSHA Research, RSA
E van Nieuwenhuizen, Doctor
Role: PRINCIPAL_INVESTIGATOR
Eastmed Clinical Trial Center, RSA
CJJ van Rensburg, Doctor
Role: PRINCIPAL_INVESTIGATOR
Private, RSA
Locations
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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
Chang-Hua Christian Hospital
Changhua, , Taiwan
E-Da Hospital
Kaohsiung City, , Taiwan
Kaoshiung Medical University Hospital
Kaoshiung, , Taiwan
Cheng Ching Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chi-Mei Foundation Hospital
Tainan City, , 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 District, , Taiwan
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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TG-873870-02
Identifier Type: -
Identifier Source: org_study_id