- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01886053
A Phase II Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
June 19, 2013 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Phase II Study to Evaluate the Efficacy and Safety of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
The purpose of this study is to evaluate the safety and Efficacy of Faropenem in community-acquired pneumonia (CAP) subjects,and explore its therapeutic dose.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
189
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China, 200040
- Huashan Hospital ,Fudan University
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Tianjin, China, 300211
- The Second Hospital Of Tianjin Medical University
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Anhui
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Hefei, Anhui, China, 230001
- Anhui Provincial Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510080
- First Affiliated Hospital of Sun Yat-sen University
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Guangzhou, Guangdong, China, 510630
- The Third Affiliated Hospital of Sun Yat-sen University
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Guangzhou, Guangdong, China, 510120
- Sun Yat-Sen Memorial Hospital Sun Yat-sen University
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Hubei
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Shiyan, Hubei, China, 442000
- Taihe Hospital in Shiyan City
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Jilin
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Changchun, Jilin, China
- The Second Hospital of Jilin University
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Shandong
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Qingdao, Shandong, China, 266000
- Qingdao Municipal Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged between 18~70 years, either male or female
- Patients requiring hospitalization or emergency room observation, and the need to receive intravenous antibiotic treatment
- Women of childbearing age having negative pregnancy test at the time of enrollment and agreeing to take effective contraceptive measures from the delivery to 7 ~14 days after stopping .(for example: oral contraception, injectable contraception, or implant contraception , spermicides and condoms, or intrauterine device).
- Comply with clinical, radiological and microbiological criteria of Community-Acquired Pneumonia(CAP):
- Patients had used ineffective systemic antimicrobial drugs before enrollment or had effective antimicrobial drugs within 72 h before enrollment, used <24 h
- Informed consent granted
Exclusion Criteria:
- Patients with atypical pneumonia infected by the Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila bacteria;
- Patients infected by pathogens methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa or Acinetobacter baumanns ;
- Viral pneumonia;
- Aspiration pneumonia;
- Hospital-acquired pneumonia, including ventilator-associated pneumonia;
- Patients with Severe pneumonia who meet one primary criterion or three secondary criteria (See Appendix);
- Patients with a rapid progressive or end-stage disease, and can not survive until the end of the study period by antibiotic treatment;
- Patients with bronchial obstruction or a history of obstructive pneumonia (not including chronic obstructive pulmonary disease);
- Suffering from any of the following diseases: active tuberculosis, bronchiectasis, lung abscess, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophil infiltration disease and pulmonary vasculitis;
- Infections acquired from hospitals, nursing homes or other long-term care facilities, or patients hospitalized within 14 days prior to enrollment ;
- Allergic to penem and carbapenem antibiotic;
- Pregnancy or lactation in women;
- Patients with uncontrolled psychiatric history or those at risk of suicide two years prior to enrollment;
- A history of epilepsy or other central nervous system disorders in patients;
- Patients with Renal dysfunction, screening serum creatinine values above the upper limit of normal 10%;
- The Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 3 times the upper limit of the reference value, or total bilirubin beyond the upper limit of the normal range by 10% ;
- Serious diseases that affecting the immune system, such as: a human immunodeficiency virus (HIV) infection history, or cluster of differentiation 4 + T-lymphocyte count <200/200/mm3, or Neutrophilic granulocytopenia (neutrophil count <1500/mm3), or hematologic malignancies or solid organ or splenectomy, etc;
- Patients who are taking steroid medications, at least 20 mg daily dose of prednisone(or equivalent doses of other glucocorticoids);
- Patients who are accepting chemotherapy drug therapy or anti-cancer therapy, or plan to accept such treatment during the trial six months prior to enrollment;
- Alcohol or illicit drug abuse history;
- Patients who have accepted any other experimental drugs within 3 months prior to enrollment;
- more than 500 ml blood donation within 3 months prior to enrollment;
- Patients who have participated in this clinical trial ever before;
- Combined use of other antibacterial drugs in patients;
- Patients are diagnosed to have potential increased risks, or there may be interference with clinical trials;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Ertapenem
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dosage form: Injection dosage:1000 mg frequency: once a day
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Experimental: Faropenem(low-dose group)
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dosage form: Injection dosage:2400 mg frequency: twice a day
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Experimental: Faropenem(high dose group)
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dosage form: Injection dosage:2400 mg frequency: Three times a day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Per subject clinical cure rate
Time Frame: 14-28 days
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14-28 days
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Per subject microbiological cure rate
Time Frame: 14-28 days
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14-28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
June 14, 2013
First Submitted That Met QC Criteria
June 19, 2013
First Posted (Estimate)
June 25, 2013
Study Record Updates
Last Update Posted (Estimate)
June 25, 2013
Last Update Submitted That Met QC Criteria
June 19, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZTDQ04104-CTF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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