Community-Acquired PneumoniaPhase 2NCT00434291
Safety and Efficacy Comparison of TG-873870(Nemonoxacin) to Levofloxacin in Community-Acquired Pneumonia
A Phase 2 study testing TG-873870(Nemonoxacin) in people with Community-Acquired Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 20 sites in 2 countries.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-Acquired Pneumonia
- What is being tested?
- TG-873870(Nemonoxacin)
- How many people
- 264 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Dec 2006to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
South Africa10 sites
Benmed/Pentagon Hospital
Benomi
MediTrials
Cape Town
Private
Kimberley
DJW Research
Krugersdorp
GCT Trial Centre, Mercantile Hospital
Port Elizabeth
Private
Potchefstroom
Bougainville Hospital
Pretoria
de Villers Clinical Trials
Scottburgh
GCT at Jubilee Hospital
Temba, North West
Park Medical Centre
Witbank
Taiwan10 sites
Chang-Hua Christian Hospital
Changhua, 114
E-Da Hospital
Kaohsiung City, 114
Kaoshiung Medical University Hospital
Kaoshiung, 114
Cheng Ching Hospital
Taichung, 114
Taichung Veterans General Hospital
Taichung, 114
Chi-Mei Foundation Hospital
Tainan, 114
Buddhist Taipei Tzu Chi General Hospital
Taipei, 114
Taipei Veterans General Hospital
Taipei, 114
Tri-Service General Hospital
Taipei, 114
Chang-Gung Memorial Hospital
Taoyuan, 114
About this study
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)
This study will test the safety and efficacy of TG-873870(Nemonoxacin) compared with Levofloxacin in adult patients with Community-Aquired Pneumonia(CAP)
Read the 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) .
- Conditions
- Community-Acquired Pneumonia
- Being tested
- TG-873870(Nemonoxacin)
- Keywords
- Community-acquired Pneumonia, fluoroquinolone, TG-873870, Nemonoxacin
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG-873870(Nemonoxacin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation
Clinical Cure Rate
Secondary outcomes (1)
Bacteriologic Cure Rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startDec 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Community-Acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Investigators
- Reury-Perng Perng, Doctor, Principal investigator, Taipei Veterans General Hospital, Taipei, TaiwanMing-Lin Ho, Doctor, Principal investigator, Chang-Hua Christian Hospital, Changhua, TaiwanWann-Cherng Perng, Doctor, Principal investigator, Tri-Service General Hospital, Taipei, TaiwanKai-Ming Chang, Doctor, Principal investigator, Taichung Veterans General Hospital, Taichung, TaiwanYen-Hsu Chen, Doctor, Principal investigator, Kaoshiung Medical University Hospital, Kaoshiung, TaiwanRen-Guang Wu, Doctor, Principal investigator, Cheng Ching Hospital, Taichung, TaiwanYin-Ching Chuang, Doctor, Principal investigator, Chi-Mei Foundation Hospital, Tainan, TaiwanHorng-Chyuan Lin, Doctor, Principal investigator, Chang-Gung Memorial Hospital, Taoyuan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434291
- Sponsor's protocol ID
- TG-873870-02
- Status last verified
- Nov 2009
- First submitted
- 12 Feb 2007
- Last updated
- 25 Nov 2009
- Results posted
- No
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. doi: 10.1086/513953.
PubMed 9564457Mandell 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.
PubMed 14614663Bartlett 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.
PubMed 10987697Fujimoto 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.
PubMed 2174762Croom 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.
PubMed 14664657Ellner 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.
PubMed 7277631
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00434291
- Acronym / sponsor ID
- TG-873870-02
- Conditions
- Community-Acquired Pneumonia
- Keywords
- Community-acquired Pneumonia, fluoroquinolone, TG-873870, Nemonoxacin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Dec 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 13 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG-873870(Nemonoxacin) | Drug | – |
Primary outcome
Safety evaluation
Clinical Cure Rate
1 secondary outcome
Bacteriologic Cure Rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
- Background: PubMed 9564457Bartlett 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.
- Background: PubMed 14614663Mandell 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.
- Background: PubMed 10987697Bartlett 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.
- Background: PubMed 2174762Fujimoto 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.
- Background: PubMed 14664657Croom 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.
- Background: PubMed 7277631Ellner 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.
- NCBILink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reury-Perng Perng, Doctor principal investigator
Taipei Veterans General Hospital, Taipei, Taiwan
Ming-Lin Ho, Doctor principal investigator
Chang-Hua Christian Hospital, Changhua, Taiwan
Wann-Cherng Perng, Doctor principal investigator
Tri-Service General Hospital, Taipei, Taiwan
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TG-873870(Nemonoxacin) in people with Community-Acquired Pneumonia, run by TaiGen Biotechnology Co., Ltd. at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Africa, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00434291, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.