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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01371838
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : September 23, 2014
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Community-Acquired Bacterial Pneumonia
Lung Infection of Individual Not Recently Hospitalized
Interventions Drug: Ceftaroline
Drug: Ceftriaxone
Enrollment 848
Recruitment Details The enrollment period was from 13 December 2011 to 26 April 2013
Pre-assignment Details Enrolled patients (patients who gave informed consent) were screened for up to 24 hours to ensure eligibility before being randomized
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Period Title: Overall Study
Started 381 383
Completed 332 317
Not Completed 49 66
Reason Not Completed
Withdrawal by Subject             27             33
Lost to Follow-up             10             20
Death             3             4
Protocol Violation             3             0
Investigator Decision             3             8
Last follow-up visit not conducted             2             0
Lack of therapeutic response             0             1
Surgery             1             0
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g Total
Hide Arm/Group Description Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h). Total of all reporting groups
Overall Number of Baseline Participants 381 382 763
Hide Baseline Analysis Population Description
All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. There was one patient with PORT risk class II who was not included in baseline analysis population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 381 participants 382 participants 763 participants
66.1  (14.70) 65.8  (13.86) 66.0  (14.28)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 381 participants 382 participants 763 participants
<65 years 155 146 301
>=65 years 226 236 462
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants 382 participants 763 participants
Female
116
  30.4%
110
  28.8%
226
  29.6%
Male
265
  69.6%
272
  71.2%
537
  70.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 381 participants 382 participants 763 participants
381 382 763
1.Primary Outcome
Title Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population
Hide Description 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
Time Frame 7-20 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 258 240
Measure Type: Number
Unit of Measure: Participants
Clinical Cure 217 178
Clinical Failure 41 62
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE in adult subjects with CABP.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated in CE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in CE Population. If non-inferioirity was achieved then a test of superioirty was conducted whereby if lower limit of 95% CI for the difference was >0% superioirty was concluded.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 9.9
Confidence Interval (2-Sided) 95%
2.8 to 17.1
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.
2.Secondary Outcome
Title Clinical Response at End of Treatment (EOT) Visit in MITT Population
Hide Description [Not Specified]
Time Frame Last day of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 381 382
Measure Type: Number
Unit of Measure: Participants
Clinical Cure 321 281
Clinical Failure 45 82
Indeterminate 15 19
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.7
Confidence Interval (2-Sided) 95%
4.9 to 16.4
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.
3.Secondary Outcome
Title Clinical Response at End of Treatment (EOT) Visit in CE Population
Hide Description [Not Specified]
Time Frame Last day of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 258 240
Measure Type: Number
Unit of Measure: Participants
Clinical Cure 222 186
Clinical Failure 36 54
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.5
Confidence Interval (2-Sided) 95%
1.8 to 15.4
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.
4.Secondary Outcome
Title Clinical Response at the Test of Cure (TOC) Visit in MITT Population
Hide Description [Not Specified]
Time Frame 7-20 days after last day of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 381 382
Measure Type: Number
Unit of Measure: Participants
Clinical Cure 305 256
Clinical Failure 53 91
Indeterminate 23 35
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
6.8 to 19.2
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments. If lower limit of 95% CI for the risk difference was >0% superioirty was concluded in this population.
5.Secondary Outcome
Title Clinical Response at the Test of Cure (TOC) Visit in mMITT Population
Hide Description [Not Specified]
Time Frame 7-20 days after last day of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 80 96
Measure Type: Number
Unit of Measure: Participants
Clinical Cure 68 67
Clinical Failure 9 21
Indeterminate 3 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 15.2
Confidence Interval (2-Sided) 95%
2.7 to 27.1
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.
6.Secondary Outcome
Title Clinical Response at the Test of Cure (TOC) Visit in ME Population
Hide Description [Not Specified]
Time Frame 7-20 days after last day of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 57 62
Measure Type: Number
Unit of Measure: Participants
Clinical Cure 50 47
Clinical Failure 7 15
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
-2.2 to 25.8
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.
7.Secondary Outcome
Title Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Hide Description [Not Specified]
Time Frame 7-20 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 57 62
Measure Type: Number
Unit of Measure: Participants
Staphylococcus aureus 4 4
Clinical Cure - Staphylococcus aureus 4 2
Clinical Failure - Staphylococcus aureus 0 2
Streptococcus pneumoniae 22 15
Clinical Cure - Streptococcus pneumoniae 19 13
Clinical Failure - Streptococcus pneumoniae 3 2
Escherichia coli 3 6
Clinical Cure - Escherichia coli 3 5
Clinical Failure - Escherichia coli 0 1
Haemophilus influenzae 12 7
Clinical Cure - Haemophilus influenzae 11 6
Clinical Failure - Haemophilus influenzae 1 1
Klebsiella pneumoniae 14 16
Clinical Cure - Klebsiella pneumoniae 11 12
Clinical Failure - Klebsiella pneumoniae 3 4
8.Secondary Outcome
Title Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population
Hide Description [Not Specified]
Time Frame 7-20 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 57 62
Measure Type: Number
Unit of Measure: Participants
Staphylococcus aureus 4 4
Favourable - Staphylococcus aureus 4 2
Unfavourable - Staphylococcus aureus 0 2
Streptococcus pneumoniae 22 15
Favourable - Streptococcus pneumoniae 19 13
Unfavourable - Streptococcus pneumoniae 3 2
Escherichia coli 3 6
Favourable - Escherichia coli 3 5
Unfavourable - Escherichia coli 0 1
Haemophilus influenzae 12 7
Favourable - Haemophilus influenzae 11 6
Unfavourable - Haemophilus influenzae 1 1
Klebsiella pneumoniae 14 16
Favourable - Klebsiella pneumoniae 11 12
Unfavourable - Klebsiella pneumoniae 3 4
9.Secondary Outcome
Title Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population
Hide Description 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.
Time Frame 7-20 days after last day of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 80 96
Measure Type: Number
Unit of Measure: Participants
Favourable 68 67
Unfavourable 9 21
Indeterminate 3 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 15.2
Confidence Interval (2-Sided) 95%
2.7 to 27.1
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.
10.Secondary Outcome
Title Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population
Hide Description 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.
Time Frame 7-20 days after last day of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 57 62
Measure Type: Number
Unit of Measure: Participants
Favourable 50 47
Unfavourable 7 15
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
-2.2 to 25.8
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.
11.Secondary Outcome
Title Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population
Hide Description [Not Specified]
Time Frame 7-20 days after last day of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 381 382
Measure Type: Number
Unit of Measure: Participants
Success 305 256
Failure 53 91
Indeterminate 23 35
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
6.8 to 19.2
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.
12.Secondary Outcome
Title Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population
Hide Description [Not Specified]
Time Frame 7-20 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 258 240
Measure Type: Number
Unit of Measure: Participants
Success 217 178
Failure 41 62
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 9.9
Confidence Interval (2-Sided) 95%
2.8 to 17.1
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.
13.Secondary Outcome
Title Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population
Hide Description [Not Specified]
Time Frame 21-42 days after last day of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. For this measure only patients who were cured at TOC could be assessed for relapse.
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 305 256
Measure Type: Number
Unit of Measure: Participants
Clinical relapse 286 244
No Clinical relapse 7 5
Indeterminate 12 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-2.5 to 3.0
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.
14.Secondary Outcome
Title Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population
Hide Description [Not Specified]
Time Frame 21-42 days after last day of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
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). For this measure only patients who were cured at TOC could be assessed for relapse.
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 217 178
Measure Type: Number
Unit of Measure: Participants
Clinical relapse 199 167
No Clinical relapse 6 3
Indeterminate 12 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline 600mg, Ceftriaxone 2g
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-2.4 to 4.5
Estimation Comments CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.
15.Secondary Outcome
Title Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population
Hide Description [Not Specified]
Time Frame 21-42 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 80 96
Measure Type: Number
Unit of Measure: Participants
Super-Infection 0 2
Favourable response at TOC 68 67
No Re-Infection Or Recurrance 68 66
Re-Infection Or Recurrance 0 1
16.Secondary Outcome
Title Microbiological Re-infection/Recurrence at LFU Visit in ME Population
Hide Description [Not Specified]
Time Frame 21-42 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description:
Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
Overall Number of Participants Analyzed 57 62
Measure Type: Number
Unit of Measure: Participants
Super-Infection 0 1
Favourable response at TOC 50 47
No Re-Infection Or Recurrance 50 46
Re-Infection Or Recurrance 0 1
Time Frame first dose, throughout the treatment period, and up to the TOC visit
Adverse Event Reporting Description All adverse events with an onset date between the date of first dose and test of cure (TOC) or 20 days following the EOT in absence of TOC and all serious adverse events with an onset date between the date of first dose and test of cure (TOC) or 30 days following the EOT in absence of TOC.
 
Arm/Group Title Ceftaroline 600mg Ceftriaxone 2g
Hide Arm/Group Description Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
All-Cause Mortality
Ceftaroline 600mg Ceftriaxone 2g
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ceftaroline 600mg Ceftriaxone 2g
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/381 (7.87%)      29/383 (7.57%)    
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION  1  1/381 (0.26%)  1 1/383 (0.26%)  1
CARDIAC ARREST  1  0/381 (0.00%)  0 1/383 (0.26%)  1
CARDIAC FAILURE  1  1/381 (0.26%)  1 0/383 (0.00%)  0
CARDIAC FAILURE ACUTE  1  1/381 (0.26%)  1 0/383 (0.00%)  0
Gastrointestinal disorders     
DIARRHOEA  1  1/381 (0.26%)  1 0/383 (0.00%)  0
UPPER GASTROINTESTINAL HAEMORRHAGE  1  1/381 (0.26%)  1 0/383 (0.00%)  0
General disorders     
ASTHENIA  1  1/381 (0.26%)  1 1/383 (0.26%)  1
NON-CARDIAC CHEST PAIN  1  1/381 (0.26%)  1 0/383 (0.00%)  0
PYREXIA  1  0/381 (0.00%)  0 1/383 (0.26%)  1
Hepatobiliary disorders     
CHOLECYSTITIS CHRONIC  1  1/381 (0.26%)  1 0/383 (0.00%)  0
CHOLELITHIASIS  1  1/381 (0.26%)  1 0/383 (0.00%)  0
Infections and infestations     
ASPERGILLOSIS  1  0/381 (0.00%)  0 1/383 (0.26%)  1
BRONCHITIS  1  0/381 (0.00%)  0 1/383 (0.26%)  1
LUNG INFECTION  1  1/381 (0.26%)  1 1/383 (0.26%)  1
PNEUMONIA  1  0/381 (0.00%)  0 1/383 (0.26%)  1
PULMONARY TUBERCULOSIS  1  0/381 (0.00%)  0 2/383 (0.52%)  2
SEPSIS  1  0/381 (0.00%)  0 1/383 (0.26%)  1
TUBERCULOSIS  1  1/381 (0.26%)  1 0/383 (0.00%)  0
URINARY TRACT INFECTION  1  1/381 (0.26%)  1 1/383 (0.26%)  1
Injury, poisoning and procedural complications     
COMPRESSION FRACTURE  1  1/381 (0.26%)  1 0/383 (0.00%)  0
FEMORAL NECK FRACTURE  1  0/381 (0.00%)  0 1/383 (0.26%)  1
THORACIC VERTEBRAL FRACTURE  1  1/381 (0.26%)  1 0/383 (0.00%)  0
Investigations     
C-REACTIVE PROTEIN INCREASED  1  1/381 (0.26%)  1 0/383 (0.00%)  0
HEPATIC ENZYME INCREASED  1  0/381 (0.00%)  0 1/383 (0.26%)  1
Metabolism and nutrition disorders     
DECREASED APPETITE  1  1/381 (0.26%)  1 1/383 (0.26%)  1
DIABETES MELLITUS  1  0/381 (0.00%)  0 1/383 (0.26%)  1
GOUT  1  1/381 (0.26%)  1 0/383 (0.00%)  0
HYPERKALAEMIA  1  1/381 (0.26%)  1 0/383 (0.00%)  0
HYPERNATRAEMIA  1  1/381 (0.26%)  1 0/383 (0.00%)  0
HYPONATRAEMIA  1  0/381 (0.00%)  0 1/383 (0.26%)  1
Musculoskeletal and connective tissue disorders     
MUSCULOSKELETAL CHEST PAIN  1  1/381 (0.26%)  1 0/383 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
HEPATIC CANCER  1  0/381 (0.00%)  0 1/383 (0.26%)  1
LUNG NEOPLASM MALIGNANT  1  1/381 (0.26%)  1 3/383 (0.78%)  3
SMALL CELL LUNG CANCER  1  1/381 (0.26%)  1 0/383 (0.00%)  0
Nervous system disorders     
COMA  1  0/381 (0.00%)  0 1/383 (0.26%)  1
DIZZINESS  1  1/381 (0.26%)  1 0/383 (0.00%)  0
Renal and urinary disorders     
URINARY RETENTION  1  1/381 (0.26%)  1 0/383 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
ACUTE RESPIRATORY DISTRESS SYNDROME  1  0/381 (0.00%)  0 1/383 (0.26%)  1
ACUTE RESPIRATORY FAILURE  1  1/381 (0.26%)  1 0/383 (0.00%)  0
ASTHMA  1  2/381 (0.52%)  2 1/383 (0.26%)  1
BRONCHIECTASIS  1  1/381 (0.26%)  1 1/383 (0.26%)  1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  2/381 (0.52%)  2 6/383 (1.57%)  6
PNEUMOTHORAX  1  2/381 (0.52%)  2 0/383 (0.00%)  0
PULMONARY EMBOLISM  1  1/381 (0.26%)  1 0/383 (0.00%)  0
Vascular disorders     
ARTERIOSCLEROSIS  1  1/381 (0.26%)  1 1/383 (0.26%)  1
HAEMATOMA  1  0/381 (0.00%)  0 1/383 (0.26%)  1
HYPERTENSIVE EMERGENCY  1  1/381 (0.26%)  1 0/383 (0.00%)  0
SHOCK  1  0/381 (0.00%)  0 1/383 (0.26%)  1
SHOCK HAEMORRHAGIC  1  1/381 (0.26%)  1 0/383 (0.00%)  0
VENOUS THROMBOSIS LIMB  1  0/381 (0.00%)  0 1/383 (0.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ceftaroline 600mg Ceftriaxone 2g
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/381 (6.30%)      13/383 (3.39%)    
Gastrointestinal disorders     
DIARRHOEA  1  24/381 (6.30%)  24 13/383 (3.39%)  13
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melnick, David A / Exec Dir Med Science
Organization: AstraZeneca Pharmaceuticals
Phone: +1 302 886 5627
EMail: David.Melnick@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01371838    
Other Study ID Numbers: D3720C00002
First Submitted: April 27, 2011
First Posted: June 13, 2011
Results First Submitted: May 28, 2014
Results First Posted: September 23, 2014
Last Update Posted: September 6, 2017