| Primary | 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 | 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). | Posted | | Number | | Participants | | 7-20 days after last dose of study drug | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
| | | Title | Denominators | Categories |
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| Clinical Cure | | | | Clinical Failure | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | | RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment. | | | Risk Difference (RD) | 9.9 | | | 2-Sided | 95 | 2.8 | 17.1 | | | CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments. | | Non-Inferiority or Equivalence |
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| Secondary | Clinical Response at End of Treatment (EOT) Visit in MITT Population | | All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. | Posted | | Number | | Participants | | Last day of study drug administration | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Clinical Response at End of Treatment (EOT) Visit in CE Population | | 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). | Posted | | Number | | Participants | | Last day of study drug administration | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Clinical Response at the Test of Cure (TOC) Visit in MITT Population | | All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. | Posted | | Number | | Participants | | 7-20 days after last day of study drug administration | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Clinical Response at the Test of Cure (TOC) Visit in mMITT Population | | 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). | Posted | | Number | | Participants | | 7-20 days after last day of study drug administration | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Clinical Response at the Test of Cure (TOC) Visit in ME Population | | ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations. | Posted | | Number | | Participants | | 7-20 days after last day of study drug administration | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population | | 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. | Posted | | Number | | Participants | | 7-20 days after last dose of study drug | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population | | 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. | Posted | | Number | | Participants | | 7-20 days after last dose of study drug | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | 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. | 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). | Posted | | Number | | Participants | | 7-20 days after last day of study drug administration | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | 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. | ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations. | Posted | | Number | | Participants | | 7-20 days after last day of study drug administration | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population | | All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. | Posted | | Number | | Participants | | 7-20 days after last day of study drug administration | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population | | 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). | Posted | | Number | | Participants | | 7-20 days after last dose of study drug | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population | | 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. | Posted | | Number | | Participants | | 21-42 days after last day of study drug administration | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population | | 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. | Posted | | Number | | Participants | | 21-42 days after last day of study drug administration | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population | | 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). | Posted | | Number | | Participants | | 21-42 days after last dose of study drug | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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| Secondary | Microbiological Re-infection/Recurrence at LFU Visit in ME Population | | ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations | Posted | | Number | | Participants | | 21-42 days after last dose of study drug | | | | ID | Title | Description |
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| OG000 | Ceftaroline 600mg | Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h) | | OG001 | Ceftriaxone 2g | 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). |
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