Clinical trial NCT00434291: Safety and Efficacy Comparison of TG-873870(Nemonoxacin) to Levofloxacin in Community-Acquired Pneumonia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Community-Acquired Pneumonia
Keywords: Community-acquired Pneumonia
fluoroquinolone
TG-873870
Nemonoxacin
Lead sponsor: TaiGen Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2007-02-13
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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) .

Eligibility 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

Primary outcomes:
measure: Safety evaluation
measure: Clinical Cure Rate
Secondary outcomes:
measure: Bacteriologic Cure Rate
Other outcomes:
Locations:
city: Temba
country: South Africa
facility: GCT at Jubilee Hospital
state: North West
city: Benomi
country: South Africa
facility: Benmed/Pentagon Hospital
city: Cape Town
country: South Africa
facility: MediTrials
city: Kimberley
country: South Africa
facility: Private
city: Krugersdorp
country: South Africa
facility: DJW Research
city: Port Elizabeth
country: South Africa
facility: GCT Trial Centre, Mercantile Hospital
city: Potchefstroom
country: South Africa
facility: Private
city: Pretoria
country: South Africa
facility: Bougainville Hospital
city: Scottburgh
country: South Africa
facility: de Villers Clinical Trials
city: Witbank
country: South Africa
facility: Park Medical Centre
city: Changhua
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Kaoshiung
country: Taiwan
facility: Kaoshiung Medical University Hospital
city: Taichung
country: Taiwan
facility: Cheng Ching Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi-Mei Foundation Hospital
city: Taipei
country: Taiwan
facility: Buddhist Taipei Tzu Chi General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang-Gung Memorial Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taipei, Taiwan
name: Reury-Perng Perng, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang-Hua Christian Hospital, Changhua, Taiwan
name: Ming-Lin Ho, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tri-Service General Hospital, Taipei, Taiwan
name: Wann-Cherng Perng, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Taichung Veterans General Hospital, Taichung, Taiwan
name: Kai-Ming Chang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaoshiung Medical University Hospital, Kaoshiung, Taiwan
name: Yen-Hsu Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cheng Ching Hospital, Taichung, Taiwan
name: Ren-Guang Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chi-Mei Foundation Hospital, Tainan, Taiwan
name: Yin-Ching Chuang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang-Gung Memorial Hospital, Taoyuan, Taiwan
name: Horng-Chyuan Lin, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Buddhist Taipei Tzu Chi General Hospital, Taipei, Taiwan
name: Yao-Kuang Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: E-Da Hospital, Kaohsiung, Taiwan
name: Hsi-Hsun Lin, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: GCT at Jubilee Hospital, RSA
name: AJ Bester, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Bougainville Hospital, RSA
name: J Breedt, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: de Villers Clinical Trials, RSA
name: CT de Villiers, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: GCT Trial Centre, Mercantile Hospital, RSA
name: M Gani, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Private, RSA
name: Y Kelfkens, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Park Medical Centre, RSA
name: DJ Jansen van Rensburg, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: DJW Research, RSA
name: J Jurgens, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Benmed/Pentagon Hospital, RSA
name: IH Mitha, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Private, RSA
name: JH Mynhardt, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: MediTrials, RSA
name: G Nieuwoudt, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: JOSHA Research, RSA
name: J Kasumba, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastmed Clinical Trial Center, RSA
name: E van Nieuwenhuizen, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Private, RSA
name: CJJ van Rensburg, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1086/380488. Epub 2003 Nov 3. No abstract available.
citation: 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.
citation: 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.
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. doi: 10.2165/00003495-200363240-00008.
citation: 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.