Community Acquired PneumoniaPhase 3NCT01937832
A Phase III Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
A Phase 3 study testing Faropenem and Ertapenem in people with Community Acquired Pneumonia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites in China.
Trial summary
The purpose of this study is to evaluate the safety and Efficacy of Faropenem in community-acquired pneumonia (CAP) subjects Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Faropenem and Ertapenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 7 sitesChina
- Study dates
- Oct 2013to Oct 2015
- Phase
- Phase 3
- 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 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between18~73 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 IUDs).
- Comply with the following 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 72h before enrollment, used <24h
- Informed consent granted
Who cannot join
- Patients with atypical pneumonia infected by the Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila bacteria;
- Patients infected by pathogens MRSA, Pseudomonas aeruginosa or Acinetobacter baumannii;
- 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);
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- 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 CD4 + 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 20mg 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 500ml 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;
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
The Second Hospital of Jilin University
Changchun, Jilin
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Anhui Provincial Hospital
Hefei, Anhui, 230001
Qingdao Municipal Hospital
Qingdao, Shandong, 266000
Huashan Hospital ,Fudan University
Shanghai, 200040
Wu Ju fang
Taihe Hospital in Shiyan City
Shiyan, Hubei, 442000
The Second Hospital of Tianjin Medical University
Tianjin, 300211
About this study
Official title: A Phase III 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
- Conditions
- Community Acquired Pneumonia
- Being tested
- Faropenem, Ertapenem
- 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.
FaropenemDrug
dosage form: Injection dosage:1200 mg frequency: Three times a day
ErtapenemDrug
dosage form: Injection dosage:1000 mg frequency: once a day
| Study group | Role | What they receive |
|---|---|---|
| Ertapenem | Active comparator | Not described Receives: Drug: Ertapenem |
| Faropenem | Experimental | Not described Receives: Drug: Faropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per subject clinical cure rate
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937832
- Sponsor's protocol ID
- CTTQ04104-3-CTF
- Status last verified
- Sep 2013
- First submitted
- 4 Sep 2013
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study to Evaluate the Efficacy and Safety of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
- ClinicalTrials.gov ID
- NCT01937832
- Acronym / sponsor ID
- CTTQ04104-3-CTF
- Conditions
- Community Acquired Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- First posted
- 10 Sep 2013 (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.
The purpose of this study is to evaluate the safety and Efficacy of Faropenem in community-acquired pneumonia (CAP) subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ertapenem | Active comparator | Drug: Ertapenem |
| Faropenem | Experimental | Drug: Faropenem |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged between18~73 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 IUDs).
- Comply with the following 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 72h before enrollment, used <24h
Key exclusion criteria (25 listed)
- Patients with atypical pneumonia infected by the Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila bacteria;
- Patients infected by pathogens MRSA, Pseudomonas aeruginosa or Acinetobacter baumannii;
- Viral pneumonia;
- Aspiration pneumonia;
- Hospital-acquired pneumonia, including ventilator-associated pneumonia;
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 |
|---|---|---|
| Faropenemdosage form: Injection dosage:1200 mg frequency: Three times a day | Drug | Faropenem |
| Ertapenemdosage form: Injection dosage:1000 mg frequency: once a day | Drug | Ertapenem |
Primary outcome
Per subject clinical cure rate
Time frame: 7-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Faropenem and Ertapenem in people with Community Acquired Pneumonia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites in China.
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 6 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wu Ju Fang (13816357099, Wujf53@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per subject clinical cure rate (time frame: 7-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2013.