Trial Outcomes & Findings for Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia (NCT NCT00621504)

Last Updated: 2017-03-14

Results Overview

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 adverse event (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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

606 participants

Primary outcome timeframe

8 to 15 days after last dose of study drug

Results posted on

2017-03-14

Participant Flow

The enrollment period was from 02 January 2008 to 29 December 2008

Patients were screened for up to 24 hours

Participant milestones

Participant milestones
Measure	Ceftaroline Fosamil for Injection Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)	IV Ceftriaxone Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Overall Study STARTED	299	307
Overall Study COMPLETED	273	282
Overall Study NOT COMPLETED	26	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Ceftaroline Fosamil for Injection Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)	IV Ceftriaxone Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Overall Study Adverse Event	1	3
Overall Study At the request of sponsor/investigator	1	0
Overall Study Withdrew consent	9	6
Overall Study Lost to Follow-up	8	10
Overall Study Other	1	0
Overall Study Death	6	6

Baseline Characteristics

Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ceftaroline Fosamil for Injection n=299 Participants Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)	IV Ceftriaxone n=307 Participants Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).	Total n=606 Participants Total of all reporting groups
Age, Customized <65 years	154 participants n=93 Participants	157 participants n=4 Participants	311 participants n=27 Participants
Age, Customized >= 65 years	145 participants n=93 Participants	150 participants n=4 Participants	295 participants n=27 Participants
Age, Continuous	61.0 years STANDARD_DEVIATION 16.6 • n=93 Participants	61.0 years STANDARD_DEVIATION 16.6 • n=4 Participants	61.0 years STANDARD_DEVIATION 16.6 • n=27 Participants
Sex: Female, Male Female	108 Participants n=93 Participants	112 Participants n=4 Participants	220 Participants n=27 Participants
Sex: Female, Male Male	191 Participants n=93 Participants	195 Participants n=4 Participants	386 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	29 participants n=93 Participants	27 participants n=4 Participants	56 participants n=27 Participants
Race/Ethnicity, Customized Non-Hispanic	270 participants n=93 Participants	280 participants n=4 Participants	550 participants n=27 Participants

PRIMARY outcome

Timeframe: 8 to 15 days after last dose of study drug

Population: The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.

Outcome measures

Outcome measures
Measure	Ceftaroline Fosamil for Injection n=291 Participants Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)	IV Ceftriaxone n=300 Participants Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations Clinical Cure	244 participants	233 participants
Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations Clinical Failure	34 participants	58 participants
Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations Indeterminate	13 participants	9 participants

Adverse Events

Ceftaroline Fosamil for Injection

Serious events: 28 serious events

Other events: 65 other events

Deaths: 0 deaths

IV Ceftriaxone

Serious events: 33 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ceftaroline Fosamil for Injection n=298 participants at risk Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)	IV Ceftriaxone n=308 participants at risk Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Gastrointestinal disorders Diarrhea	4.7% 14/298 • Number of events 14 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	2.3% 7/308 • Number of events 7 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Nervous system disorders Headache	3.4% 10/298 • Number of events 10 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	1.3% 4/308 • Number of events 4 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Psychiatric disorders Insomnia	3.0% 9/298 • Number of events 9 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	1.9% 6/308 • Number of events 6 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Gastrointestinal disorders Nausea	2.7% 8/298 • Number of events 8 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	2.6% 8/308 • Number of events 8 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Gastrointestinal disorders Constipation	2.3% 7/298 • Number of events 7 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	1.6% 5/308 • Number of events 5 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Vascular disorders Phlebitis	2.3% 7/298 • Number of events 7 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	1.6% 5/308 • Number of events 5 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Vascular disorders Hypertension	2.0% 6/298 • Number of events 6 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	2.6% 8/308 • Number of events 8 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Metabolism and nutrition disorders Hypokalemia	1.3% 4/298 • Number of events 4 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	3.2% 10/308 • Number of events 10 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug

Additional Information

Vice President, Clinical Sciences

Cerexa, Inc

Phone: (510) 285-9200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ceftaroline Fosamil for Injection n=298 participants at risk Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)	IV Ceftriaxone n=308 participants at risk Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Blood and lymphatic system disorders Anemia	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Blood and lymphatic system disorders Lymphadenitis	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Cardiac disorders Cardiac failure	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Cardiac disorders Left ventricular failure	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Cardiac disorders Ventricular tachycardia	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Cardiac disorders Cardiac failure acute	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Cardiac disorders Cardiac failure congestive	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Cardiac disorders Cardio-respiratory arrest	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Cardiac disorders Cardiomyopathy	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Cardiac disorders Cardiopulmonary failure	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Cardiac disorders Myocardial infarction	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Gastrointestinal disorders Gastritis	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Gastrointestinal disorders Gastrointestinal perforation	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
General disorders Sudden death	0.67% 2/298 • Number of events 2 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
General disorders Multiorgan disorder	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Hepatobiliary disorders Acute hepatic failure	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Hepatobiliary disorders Cholecystitis acute	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.65% 2/308 • Number of events 2 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Hepatobiliary disorders Hepatic failure	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Immune system disorders Hypersensitivity	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Pneumonia	0.67% 2/298 • Number of events 2 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	1.6% 5/308 • Number of events 5 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Bronchitis	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Empyema	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.65% 2/308 • Number of events 2 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Pyothorax	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Sepsis	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Tuberculosis	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Cellulitis	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Endocarditis	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Gastroenteritis	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.65% 2/308 • Number of events 2 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Lung abscess	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Pulmonary tuberculosis	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Infections and infestations Urosepsis	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Investigations Liver function test abnormal	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Metabolism and nutrition disorders Diabetes mellitus	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Metabolism and nutrition disorders Gout	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer, state unspecified	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Nervous system disorders Thrombotic stroke	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Renal and urinary disorders Urinary retention	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.67% 2/298 • Number of events 2 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.65% 2/308 • Number of events 2 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Vascular disorders Aortic aneurysm	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Vascular disorders Aortic dissection	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Vascular disorders Deep vein thrombosis	0.00% 0/298 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.32% 1/308 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Cardiac disorders Ischemic cardiomyopathy	0.34% 1/298 • Number of events 1 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug	0.00% 0/308 Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug