Community-Acquired Bacterial PneumoniaPhase 3NCT01371838
A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia
A Phase 3 study testing Ceftaroline and Ceftriaxone in people with Community-Acquired Bacterial Pneumonia and Lung Infection of Individual Not Recently Hospitalized, run by Pfizer at 43 sites in 5 countries.
Trial summary
This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia. Read more about this study
- Who is it for?
- Ages 18 to 150 years
- Conditions the study is for
- Community-Acquired Bacterial Pneumonia, Lung Infection of Individual Not Recently Hospitalized
- What is being tested?
- Ceftaroline and Ceftriaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 848 participants
- Where
- 43 sitesin 5 countries
- Study dates
- Dec 2011to May 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 150 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 18 or more years of age
- Lung Infection of Individual not Recently Hospitalized meeting the following criteria: Radiographically-confirmed pneumonia (new or progressive infection site of the lungs) consistent with bacterial pneumonia), AND Acute illness (≤ 7 days duration) with at least three of the following clinical signs or symptoms consistent with lung infection: New or increased cough, Purulent sputum or change in sputum character, Auscultatory findings consistent with pneumonia, Difficulty in breathing, short breath, or decreased partial pressure of oxygen in blood, Fever greater than 38ºC oral or body temperature lower than that required for normal body function(< 35ºC), White blood cell count greater than or less than the normal, Greater than 15% immature neutrophils (bands) irrespective of white blood cell count, AND Moderate lung infection
- The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care
- The subject's infection would require initial treatment with intravenous antimicrobials
- Female subjects of child-bearing potential, and those who are fewer than 2 years post-menopausal, must agree to, and comply with, using highly effective methods of birth control while participating in this study
Who cannot join
- Lung Infection of Individual not Recently Hospitalized suitable for outpatient therapy with an oral antimicrobial agent
- Confirmed or suspected respiratory tract infections attributable to sources other than bacteria from the individuals not recently hospitalized(e.g., ventilator-associated pneumonia, hospital-acquired pneumonia, visible/gross aspiration pneumonia, suspected viral, fungal, or mycobacterial infection of the lung)
- Non-infectious causes of lung lesion (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
- Accumulation of pus in the pleural cavity
- Microbiologically-documented infection with a pathogen known to be resistant to ceftriaxone, or epidemiological or clinical context suggesting high likelihood of a ceftriaxone-resistant "typical" bacterial pathogen.
Trial locations and contacts
43 sites in 5 countries.
43 sites in 5 countries
China13 sites
Research Site
Beijing
Research Site
Chengdu
Research Site
Guangzhou
Research Site
Haikou
Research Site
Hangzhou
Research Site
Hefei
Research Site
Jiangyin
Research Site
Nanchang
Research Site
Shanghai
Research Site
Shenyang
Research Site
Shenzhen
Research Site
Shijiazhuang
Research Site
Wuxi
India12 sites
Research Site
Bangalore
Research Site
Calicut
Research Site
Goa
Research Site
Hyderabad
Research Site
Jaipur
Research Site
Lucknow
Research Site
Ludhiana
Research Site
Mysore
Research Site
New Delhi
Research Site
Trivandrum
Research Site
Varanasi
Research Site
Vellore
South Korea10 sites
Research Site
Anyang-si
Research Site
Bucheon-si
Research Site
Cheonan-si
Research Site
Chuncheon
Research Site
Daegu
Research Site
Daejeon
Research Site
Incheon
Research Site
Seoul
Research Site
Suwon
Research Site
Wŏnju
Taiwan4 sites
Research Site
Kaohsiung City
Research Site
Keelung
Research Site
Taichung
Research Site
Taipei
Vietnam4 sites
Research Site
Can Tho
Research Site
Hanoi
Research Site
Ho Chi Minh City
Research Site
Hochiminh
About this study
Official title: A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia
This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia.
- Conditions
- Community-Acquired Bacterial Pneumonia, Lung Infection of Individual Not Recently Hospitalized
- Being tested
- Ceftaroline, Ceftriaxone
- Keywords
- Community-Acquired Bacterial Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftarolineDrug
Two consecutive infusions q12h for 5 to 7 days
CeftriaxoneDrug
One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline | Experimental | Not described Receives: Drug: Ceftaroline |
| Ceftriaxone plus placebo | Active comparator | Not described Receives: Drug: Ceftriaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population
Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome
Measured: 7-20 days after last dose of study drug
Secondary outcomes (15)
Clinical Response at End of Treatment (EOT) Visit in MITT Population
Measured: Last day of study drug administration
Clinical Response at End of Treatment (EOT) Visit in CE Population
Measured: Last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in MITT Population
Measured: 7-20 days after last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in mMITT Population
Measured: 7-20 days after last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in ME Population
Measured: 7-20 days after last day of study drug administration
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Measured: 7-20 days after last dose of study drug
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Measured: 7-20 days after last dose of study drug
Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population
An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.
Measured: 7-20 days after last day of study drug administration
Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population
An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.
Measured: 7-20 days after last day of study drug administration
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population
Measured: 7-20 days after last day of study drug administration
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population
Measured: 7-20 days after last dose of study drug
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population
Measured: 21-42 days after last day of study drug administration
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population
Measured: 21-42 days after last day of study drug administration
Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population
Measured: 21-42 days after last dose of study drug
Microbiological Re-infection/Recurrence at LFU Visit in ME Population
Measured: 21-42 days after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Community-Acquired Bacterial PneumoniaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- David Melnick, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371838
- Sponsor's protocol ID
- D3720C00002
- Status last verified
- Sep 2017
- First submitted
- 27 Apr 2011
- Last updated
- 6 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Zhuo C, Huang Y, Liu W, Xu JF, Zhu WY, Stone GG, Yan JL, Mohamed N. Efficacy and Safety of Ceftaroline Fosamil in Hospitalized Patients with Community-Acquired Pneumonia in China: Subset Analysis of an International Phase 3 Randomized Controlled Trial. Infect Drug Resist. 2022 Feb 23;15:605-617. doi: 10.2147/IDR.S342558. eCollection 2022.
PubMed 35237053Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.
PubMed 34922058Li J, Das S, Zhou D, Al-Huniti N. Population Pharmacokinetic Modeling and Probability of Target Attainment Analyses in Asian Patients With Community-Acquired Pneumonia Treated With Ceftaroline Fosamil. Clin Pharmacol Drug Dev. 2019 Jul;8(5):682-694. doi: 10.1002/cpdd.673. Epub 2019 May 1.
PubMed 31044546Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.
PubMed 30597021Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.
PubMed 30380060Taboada M, Melnick D, Iaconis JP, Sun F, Zhong NS, File TM, Llorens L, Friedland HD, Wilson D. Ceftaroline fosamil versus ceftriaxone for the treatment of community-acquired pneumonia: individual patient data meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2016 Apr;71(4):862-70. doi: 10.1093/jac/dkv415. Epub 2015 Dec 24.
PubMed 26702925Zhong NS, Sun T, Zhuo C, D'Souza G, Lee SH, Lan NH, Chiang CH, Wilson D, Sun F, Iaconis J, Melnick D. Ceftaroline fosamil versus ceftriaxone for the treatment of Asian patients with community-acquired pneumonia: a randomised, controlled, double-blind, phase 3, non-inferiority with nested superiority trial. Lancet Infect Dis. 2015 Feb;15(2):161-71. doi: 10.1016/S1473-3099(14)71018-7. Epub 2014 Dec 22.
PubMed 25539586
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia
- ClinicalTrials.gov ID
- NCT01371838
- Acronym / sponsor ID
- D3720C00002
- Conditions
- Community-Acquired Bacterial Pneumonia, Lung Infection of Individual Not Recently Hospitalized
- Keywords
- Community-Acquired Bacterial Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- Dec 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Posted 23 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftaroline | Experimental | Drug: Ceftaroline |
| Ceftriaxone plus placebo | Active comparator | Drug: Ceftriaxone |
Who may qualify
- Ages
- 18 to 150 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females 18 or more years of age
- Lung Infection of Individual not Recently Hospitalized meeting the following criteria: Radiographically-confirmed pneumonia (new or progressive infection site of the lungs) consistent with bacterial pneumonia), AND Acute illness (≤ 7 days duration) with at least three of the following clinical signs or symptoms consistent with lung infection: New or increased cough, Purulent sputum or change in sputum character, Auscultatory findings consistent with pneumonia, Difficulty in breathing, short breath, or decreased partial pressure of oxygen in blood, Fever greater than 38ºC oral or body temperature lower than that required for normal body function(< 35ºC), White blood cell count greater than or less than the normal, Greater than 15% immature neutrophils (bands) irrespective of white blood cell count, AND Moderate lung infection
- The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care
- The subject's infection would require initial treatment with intravenous antimicrobials
- Female subjects of child-bearing potential, and those who are fewer than 2 years post-menopausal, must agree to, and comply with, using highly effective methods of birth control while participating in this study
Key exclusion criteria (5 listed)
- Lung Infection of Individual not Recently Hospitalized suitable for outpatient therapy with an oral antimicrobial agent
- Confirmed or suspected respiratory tract infections attributable to sources other than bacteria from the individuals not recently hospitalized(e.g., ventilator-associated pneumonia, hospital-acquired pneumonia, visible/gross aspiration pneumonia, suspected viral, fungal, or mycobacterial infection of the lung)
- Non-infectious causes of lung lesion (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
- Accumulation of pus in the pleural cavity
- Microbiologically-documented infection with a pathogen known to be resistant to ceftriaxone, or epidemiological or clinical context suggesting high likelihood of a ceftriaxone-resistant "typical" bacterial pathogen.
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 |
|---|---|---|
| CeftarolineTwo consecutive infusions q12h for 5 to 7 days | Drug | Ceftaroline |
| CeftriaxoneOne dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h. | Drug | Ceftriaxone plus placebo |
Primary outcome
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population
Time frame: 7-20 days after last dose of study drug
Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome
15 secondary outcomes
Clinical Response at End of Treatment (EOT) Visit in MITT Population
Time frame: Last day of study drug administration
Clinical Response at End of Treatment (EOT) Visit in CE Population
Time frame: Last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in MITT Population
Time frame: 7-20 days after last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in mMITT Population
Time frame: 7-20 days after last day of study drug administration
Clinical Response at the Test of Cure (TOC) Visit in ME Population
Time frame: 7-20 days after last day of study drug administration
Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Time frame: 7-20 days after last dose of study drug
Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Time frame: 7-20 days after last dose of study drug
Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population
Time frame: 7-20 days after last day of study drug administration
Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population
Time frame: 7-20 days after last day of study drug administration
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population
Time frame: 7-20 days after last day of study drug administration
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population
Time frame: 7-20 days after last dose of study drug
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population
Time frame: 21-42 days after last day of study drug administration
Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population
Time frame: 21-42 days after last day of study drug administration
Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population
Time frame: 21-42 days after last dose of study drug
Microbiological Re-infection/Recurrence at LFU Visit in ME Population
Time frame: 21-42 days after last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35237053Zhuo C, Huang Y, Liu W, Xu JF, Zhu WY, Stone GG, Yan JL, Mohamed N. Efficacy and Safety of Ceftaroline Fosamil in Hospitalized Patients with Community-Acquired Pneumonia in China: Subset Analysis of an International Phase 3 Randomized Controlled Trial. Infect Drug Resist. 2022 Feb 23;15:605-617. doi: 10.2147/IDR.S342558. eCollection 2022.
- Derived from this study: PubMed 34922058Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.
- Derived from this study: PubMed 31044546Li J, Das S, Zhou D, Al-Huniti N. Population Pharmacokinetic Modeling and Probability of Target Attainment Analyses in Asian Patients With Community-Acquired Pneumonia Treated With Ceftaroline Fosamil. Clin Pharmacol Drug Dev. 2019 Jul;8(5):682-694. doi: 10.1002/cpdd.673. Epub 2019 May 1.
- Derived from this study: PubMed 30597021Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.
- Derived from this study: PubMed 30380060Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.
- Derived from this study: PubMed 26702925Taboada M, Melnick D, Iaconis JP, Sun F, Zhong NS, File TM, Llorens L, Friedland HD, Wilson D. Ceftaroline fosamil versus ceftriaxone for the treatment of community-acquired pneumonia: individual patient data meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2016 Apr;71(4):862-70. doi: 10.1093/jac/dkv415. Epub 2015 Dec 24.
- Derived from this study: PubMed 25539586Zhong NS, Sun T, Zhuo C, D'Souza G, Lee SH, Lan NH, Chiang CH, Wilson D, Sun F, Iaconis J, Melnick D. Ceftaroline fosamil versus ceftriaxone for the treatment of Asian patients with community-acquired pneumonia: a randomised, controlled, double-blind, phase 3, non-inferiority with nested superiority trial. Lancet Infect Dis. 2015 Feb;15(2):161-71. doi: 10.1016/S1473-3099(14)71018-7. Epub 2014 Dec 22.
- D3720C00002 CSR SynopsisLink provided by the sponsor.
- Revised CSPLink 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.
David Melnick study director
AstraZeneca
43 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ceftaroline and Ceftriaxone in people with Community-Acquired Bacterial Pneumonia and Lung Infection of Individual Not Recently Hospitalized, run by Pfizer at 43 sites in 5 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 5 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 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in China, India, South Korea, Taiwan, Vietnam. 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?
Yes. Results are posted in the registry (first posted 23 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population (time frame: 7-20 days after last dose of study drug). 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 NCT01371838, which also lists 7 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 6 Sep 2017.