A Phase II Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
A Phase II Study to Evaluate the Efficacy and Safety of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
1 other identifier
interventional
189
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2011
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 14, 2013
CompletedFirst Posted
Study publicly available on registry
June 25, 2013
CompletedJune 25, 2013
June 1, 2013
1.3 years
June 14, 2013
June 19, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Per subject clinical cure rate
14-28 days
Per subject microbiological cure rate
14-28 days
Study Arms (3)
Ertapenem
ACTIVE COMPARATORFaropenem（low-dose group)
EXPERIMENTALFaropenem（high dose group）
EXPERIMENTALInterventions
dosage form: Injection dosage:2400 mg frequency: Three times a day
dosage form: Injection dosage:2400 mg frequency: twice a day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Taihe Hospital in Shiyan City
Shiyan, Hubei, 442000, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266000, China
Huashan Hospital ,Fudan University
Shanghai, 200040, China
The Second Hospital of Tianjin Medical University
Tianjin, 300211, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2013
First Posted
June 25, 2013
Study Start
April 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
June 25, 2013
Record last verified: 2013-06