Trial · NCT01371838
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
NCT01371838, Phase 3, Completed, Pfizer; results first posted 2014-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01371838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01371838
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT01371838
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 848 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Community-Acquired Bacterial Pneumonia, Lung Infection of Individual Not Recently Hospitalized
- Interventions
- Ceftaroline, Ceftriaxone
- First posted
- 2011-06-13
- Last updated
- 2017-09-06
- Results first posted
- 2014-09-23
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population | 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 |
| Secondary | Clinical Response at End of Treatment (EOT) Visit in MITT Population | Last day of study drug administration | |
| Secondary | Clinical Response at End of Treatment (EOT) Visit in CE Population | Last day of study drug administration | |
| Secondary | Clinical Response at the Test of Cure (TOC) Visit in MITT Population | 7-20 days after last day of study drug administration | |
| Secondary | Clinical Response at the Test of Cure (TOC) Visit in mMITT Population | 7-20 days after last day of study drug administration | |
| Secondary | Clinical Response at the Test of Cure (TOC) Visit in ME Population | 7-20 days after last day of study drug administration | |
| Secondary | Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population | 7-20 days after last dose of study drug | |
| Secondary | Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population | 7-20 days after last dose of study drug | |
| Secondary | Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population | 7-20 days after last day of study drug administration | 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. |
| Secondary | Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population | 7-20 days after last day of study drug administration | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population | 7-20 days after last dose of study drug | CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient's outcome (ie, the patient does not have an indeterminate outcome). | Participants | NUMBER |
| SECONDARY | Clinical Response at End of Treatment (EOT) Visit in MITT Population | Last day of study drug administration | All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. | Participants | NUMBER |
| SECONDARY | Clinical Response at End of Treatment (EOT) Visit in CE Population | Last day of study drug administration | CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient's outcome (ie, the patient does not have an indeterminate outcome). | Participants | NUMBER |
| SECONDARY | Clinical Response at the Test of Cure (TOC) Visit in MITT Population | 7-20 days after last day of study drug administration | All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. | Participants | NUMBER |
| SECONDARY | Clinical Response at the Test of Cure (TOC) Visit in mMITT Population | 7-20 days after last day of study drug administration | mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid). | Participants | NUMBER |
| SECONDARY | Clinical Response at the Test of Cure (TOC) Visit in ME Population | 7-20 days after last day of study drug administration | ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations. | Participants | NUMBER |
| SECONDARY | Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population | 7-20 days after last dose of study drug | ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections. | Participants | NUMBER |
| SECONDARY | Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population | 7-20 days after last dose of study drug | ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections. | Participants | NUMBER |
| SECONDARY | Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population | 7-20 days after last day of study drug administration | mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid). | Participants | NUMBER |
| SECONDARY | Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population | 7-20 days after last day of study drug administration | ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations. | Participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population | Ceftaroline 600mg | Clinical Cure | 217 | Participants | |
| Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population | Ceftriaxone 2g | Clinical Cure | 178 | Participants | |
| Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population | Ceftaroline 600mg | Clinical Failure | 41 | Participants | |
| Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population | Ceftriaxone 2g | Clinical Failure | 62 | Participants | |
| Clinical Response at End of Treatment (EOT) Visit in MITT Population | Ceftaroline 600mg | Clinical Cure | 321 | Participants | |
| Clinical Response at End of Treatment (EOT) Visit in MITT Population | Ceftriaxone 2g | Clinical Cure | 281 | Participants | |
| Clinical Response at End of Treatment (EOT) Visit in MITT Population | Ceftaroline 600mg | Clinical Failure | 45 | Participants | |
| Clinical Response at End of Treatment (EOT) Visit in MITT Population | Ceftriaxone 2g | Clinical Failure | 82 | Participants | |
| Clinical Response at End of Treatment (EOT) Visit in MITT Population | Ceftaroline 600mg | Indeterminate | 15 | Participants | |
| Clinical Response at End of Treatment (EOT) Visit in MITT Population | Ceftriaxone 2g | Indeterminate | 19 | Participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ceftaroline 600mg | 381 | |
| Overall Study | STARTED | Ceftriaxone 2g | 383 | |
| Overall Study | COMPLETED | Ceftaroline 600mg | 332 | |
| Overall Study | COMPLETED | Ceftriaxone 2g | 317 | |
| Overall Study | NOT COMPLETED | Ceftaroline 600mg | 49 | |
| Overall Study | NOT COMPLETED | Ceftriaxone 2g | 66 |
Source ClinicalTrials.gov
Adverse events102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | DIARRHOEA | Gastrointestinal disorders | Ceftaroline 600mg | 24 | 381 | 24 |
| other | DIARRHOEA | Gastrointestinal disorders | Ceftriaxone 2g | 13 | 383 | 13 |
| serious | ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | Ceftaroline 600mg | 1 | 381 | 1 |
| serious | ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | Ceftriaxone 2g | 1 | 383 | 1 |
| serious | CARDIAC ARREST | Cardiac disorders | Ceftaroline 600mg | 0 | 381 | 0 |
| serious | CARDIAC ARREST | Cardiac disorders | Ceftriaxone 2g | 1 | 383 | 1 |
| serious | CARDIAC FAILURE | Cardiac disorders | Ceftaroline 600mg | 1 | 381 | 1 |
| serious | CARDIAC FAILURE | Cardiac disorders | Ceftriaxone 2g | 0 | 383 | 0 |
| serious | CARDIAC FAILURE ACUTE | Cardiac disorders | Ceftaroline 600mg | 1 | 381 | 1 |
| serious | CARDIAC FAILURE ACUTE | Cardiac disorders | Ceftriaxone 2g | 0 | 383 | 0 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ceftaroline 600mg | ||
| Total, all-cause mortality | Ceftriaxone 2g | ||
| Total, other adverse events | Ceftaroline 600mg | 24 | 381 |
| Total, other adverse events | Ceftriaxone 2g | 13 | 383 |
| Total, serious adverse events | Ceftaroline 600mg | 30 | 381 |
| Total, serious adverse events | Ceftriaxone 2g | 29 | 383 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ceftaroline 600mg vs Ceftriaxone 2g: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01371838/results?page=2