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

• Sponsor: Forest Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00621504
• Collaborator: (none)
• Enrollment: 606
• Locations: 168
• Arms: 2
• Duration (Months): 17
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

Condition or Disease	Intervention/Treatment	Phase
Bacterial Pneumonia	Drug: Ceftaroline fosamil for Injection; Drug: IV Ceftriaxone; Drug: Placebo; Drug: Clarithromycin	Phase 3

Detailed Description

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries

Study Design

• Study Type: Interventional
• Actual Enrollment: 606 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ceftaroline fosamil for Injection Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h). In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.	Drug: Ceftaroline fosamil for Injection; 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days; Drug: Clarithromycin; In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
Active Comparator: 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). In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.	Drug: IV Ceftriaxone; 1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days; Other Names: Ceftriaxone ; Drug: Placebo; Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind; Drug: Clarithromycin; In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

Outcome Measures

Primary Outcome Measures

1. Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations [8 to 15 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 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

2. Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population [8-15 days after last dose of study drug]

Secondary Outcome Measures

1. Clinical Response at End of Therapy (EOT) [Last day of study drug administration]

2. Microbiological Success Rate at Test of Cure (TOC) [8-15 days after last dose of study drug]

3. Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) [8-15 days after last day of study drug]

4. Clinical and Microbiological Response by Pathogen at TOC [8-15 days after last dose of study drug]

5. Clinical Relapse at Late Follow Up (LFU) [21-35 days after last dose of study drug]

6. Microbiological Re-infection/Recurrence at LFU [21 to 35 days after last dose of study drug]

7. Evaluate Safety [first dose, throughout the treatment period, and up to the TOC visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Subjects are required to meet the following inclusion criteria:

• Community-acquired pneumonia

• initial hospitalization, or treatment in an emergency room or urgent care setting

• infection would require initial treatment with IV antimicrobials.

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

• CAP suitable for outpatient therapy with an oral antimicrobial agent

• respiratory tract infections not due to community-acquired bacterial

• Non-infectious causes of pulmonary infiltrates

• Pleural empyema

• Infection with an atypical organism

• History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial

• History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational site	Los Angeles	California	United States	90015
2	Investigational Site	Pasadena	California	United States	91105
3	Investigational Site	Sacramento	California	United States	95817
4	Investigational Site	San Diego	California	United States	92114
5	Investigational Site	Orlando	Florida	United States	32806
6	Investigational Site	Fort Gordon	Georgia	United States	30905
7	Investigational Site	Peoria	Illinois	United States	61603
8	Investigational Site	Baltimore	Maryland	United States	21237
9	Investigational site	Minneapolis	Minnesota	United States	55422
10	Investigational Site	Butte	Montana	United States	59701
11	Investigational Site	Akron	Ohio	United States	44305
12	Investigational Site	Houston	Texas	United States	77030
13	Investigational Site	Buenos Aires	C.a.b.a.	Argentina	C1431FWO
14	Investigational Site	San Miguel de Tucuman	Tucuman	Argentina	T4000IIH
15	Investigational Site	Buenos Aires		Argentina	1650
16	Investigational Site	Buenos Aires		Argentina	1748
17	Investigational Site	Buenos Aires		Argentina	B1702FWM
18	Investigational Site	Buenos Aires		Argentina	B6700AQJ
19	Investigational Site	Buenos Aires		Argentina	C1155ADP
20	Investigational Site	Buenos Aires		Argentina	C1430BKC
21	Investigational Site	Buenos Aires		Argentina	C1437 BZK
22	Investigational Site	Vicente Lopez		Argentina	1602
23	Investigational Site	Vienna		Austria	A-1090
24	Investigational Site	Wien		Austria	A-1030
25	Investigational Site	Goiania	G.o.	Brazil	74465-539
26	Investigational Site	Porto Alegre	RS	Brazil	90020-090
27	Investigational Site	Porto Alegre	RS	Brazil	90610-001
28	Investigational Site	Sao Jose do Rio Preto	SP	Brazil	15090-000
29	Investigational Site 1	Belo Horizonte MG		Brazil	30150-221
30	Investigational Site 2	Belo Horizonte		Brazil	30140-062
31	Investigational Site	Campinas		Brazil	SP 13059-900
32	Investigational Site	Curitiba-PR		Brazil	80810-040
33	Investigational Site	Juiz de Fora		Brazil	36036-110
34	Investigational site	Porto Alegre		Brazil	90035-001
35	Investigational Site	Sao Paolo		Brazil	04038-905
36	Investigational Site	Sao Paolo		Brazil	17201-340
37	Investigational Site	Burgas		Bulgaria	8000
38	Investigational Site	Sofia		Bulgaria	1431
39	Investigational Site	Varna		Bulgaria	9010
40	Investigational Site	Tallinn		Estonia	10138
41	Investigational Site	Tallinn		Estonia	13419
42	Investigational Site	Tartu		Estonia	51014
43	Investigational Site	Annecy		France	74000
44	Investigational Site	Argenteuil		France	95100
45	Investigational Site	Paris		France	750120
46	Investigational Site	Paris		France	75475
47	Investigational Site	Paris		France	75674
48	Investigational Site	Tbilisi		Georgia	0144
49	Investigational Site	Tbilisi		Georgia	0160
50	Investigational Site	Lindenberger	Berlin	Germany	13125
51	Investigational Site	Berlin		Germany	13353
52	Investigational Site	Bochum		Germany	44793
53	Investigational Site	Bochum		Germany	44879
54	Investigational Site	Erfurt		Germany	99089
55	Investigational Site	Heppenheim		Germany	64646
56	Investigational Site	Lich		Germany	53545
57	Investigational Site	Lubeck		Germany	23538
58	Investigational Site	Luedenscheid		Germany	58515
59	Investigational Site	Paderborn		Germany	33098
60	Investigational Site	Schkeuditz		Germany	04435
61	Investigational Site	Ulm		Germany	89081
62	Investigational Site	Wiesbaden		Germany	65199
63	Investigational Site	Tatabanya	Szanatorium	Hungary	2800
64	Investigational Site	Budapest		Hungary	1125
65	Investigational Site	Matrahaza		Hungary	3233
66	Investigational Site	Miskolc		Hungary	3529
67	Investigational Site	Pecs		Hungary	7623
68	Investigational Site	Sopron		Hungary	9400
69	Investigational Site	Tatabanya		Hungary	2800
70	Investigational Site	Torokbalint		Hungary	2045
71	Investigational Site	Vellore	Tamilnadu	India	632004
72	Investigational Site	Kaunas		Lithuania	LT-45130
73	Investigational Site	Kaunas		Lithuania	LT-50009
74	Investigational Site	Klaipeda		Lithuania	LT-92231
75	Investigational Site	Klaipeda		Lithuania	LT-92288
76	Investigational Site	Siauliai		Lithuania	LT-76231
77	Investigational Site	Vilnius		Lithuania	LT-10207
78	Investigational Site	Johor Bahru	Johor	Malaysia	80100
79	Inestigational Site	Cheras	Kuala Lumpur	Malaysia	05460
80	Investigational Site	Georgetown	Penang	Malaysia	10990
81	Investigational Site	Kedah		Malaysia	05460
82	Investigational Site	Kuala Lumpur		Malaysia	50590
83	Investigational Site	Bedzin		Poland	42-500
84	Investigational Site	Brzesku		Poland	32-800
85	Investigational Site	Bytom		Poland	41-902
86	Investigational Site	Chodziez		Poland	64-800
87	Investigational Site	Czestochowa		Poland	42-200
88	Investigational Site	Katowice-Ochojec		Poland	40-635
89	Investigational Site	Krakow		Poland	30-053
90	Investigational Site	Lublin		Poland	20-178
91	Investigational Site	Lublin		Poland	20-718
92	Investigational Site	Poznan		Poland	60-479
93	Investigational Site	Poznan		Poland	60-569
94	Investigational Site	Tychy		Poland	43-100
95	Investigational Site	Warszawa		Poland	01-138
96	Investigational Site	Warszawa		Poland	03-401
97	Investigational Site	Warszawa		Poland	03-737
98	Investigational Site	Warszawa		Poland	127 02-507
99	Investigational Site	Wroclaw		Poland	53-439
100	Inestigational Site	Bucharest		Romania	042122
101	Investigational Site	Bucharest		Romania	050098
102	Investigational Site	Cluj Napoca		Romania	400238
103	Investigational Site	Constanta		Romania
104	Investigational Site	Oradea		Romania	410176
105	Investigational Site	St. Brasov		Romania	25-27
106	Investigational Site	Targu Mures		Romania	540136
107	Investigational Site	Timisoara		Romania
108	Investigational Site	Petrozavodsk	Republic of Karelia	Russian Federation	185014
109	Investigational Site	Arkhangelsk		Russian Federation	163045
110	Investigational Site	Moscow		Russian Federation	119048
111	Investigational Site	Moscow		Russian Federation	123182
112	Investigational Site	Moscow		Russian Federation	125206
113	Investigational Site	Rostov-on-Don		Russian Federation	344010
114	Investigational Site	Saratov		Russian Federation	410-002
115	Investigational Site	St Petersburg		Russian Federation	194354
116	Investigational Site	St. Petersburg		Russian Federation	191104
117	Investigational Site	St. Petersburg		Russian Federation	195257
118	Investigational Site	Tatarstan		Russian Federation	420-101
119	Investigational Site	Yekaterinburg		Russian Federation	620109
120	Investigational Site	Yekaterinburg		Russian Federation	620137
121	Investigational Site	Belgrade		Serbia	11080
122	Investigational Site	Knez Selo		Serbia	18204
123	Investigational Site	Kragujevac		Serbia	34000
124	Investigational Site	Bratislava		Slovakia	813 69
125	Slovakia	Nitra-Zobor		Slovakia	948 88
126	Investigational Site	Bellville	Capetown	South Africa	7530
127	Investigational Site	Benomi		South Africa	1500
128	Investigational Site	Cape Town		South Africa	7505
129	Investigational Site	Cape Town		South Africa	7530
130	Investigational Site	Krugersdorp		South Africa	1752
131	Investigational Site	Port Elizabeth		South Africa	6020
132	Investigational Site	Pretoria		South Africa	0001
133	Investigational Site	Pretoria		South Africa	0084
134	Investigational Site	Pretoria		South Africa	0140
135	Investigational Site	Pretoria		South Africa	0188
136	Investigational Site	Somerset West		South Africa	7130
137	Investigational Site	Worcester		South Africa	6850
138	Investigational Site	Barcelona		Spain	08035
139	Investigational Site	Barcelona		Spain	08036
140	Investigational Site	Elche		Spain	03203
141	Investigational Site	Leon		Spain	24411
142	Investigational Site	Madrid		Spain	28007
143	Investigational Site	Valencia		Spain	46009
144	Investigational Site	Vizcaya		Spain	48960
145	Investigational Site	Biel		Switzerland	2501
146	Investigational Site	Geneve		Switzerland	1211
147	Investigational Site	La Chaux-de-Fonds		Switzerland	2300
148	Investigational Site	Lugano		Switzerland	46,6903
149	Investigational Site	Bangkok		Thailand	10110
150	Investigational Site	Bangkok		Thailand	10400
151	InvestigationalSite	Bangkok		Thailand	10400
152	Investigational Site	Bangkok		Thailand	10700
153	Investigational Site	Chiang Mai		Thailand	50200
154	Investigational Site	Khonkaen		Thailand	40002
155	Investigational Site	Nonthaburi		Thailand	11000
156	Investigational Site	Aviv		Ukraine	79013
157	Investigational Site	Dnipropetrovsk		Ukraine	49074
158	Investigational Site	Dnipropetrovsk		Ukraine	49102
159	Investigational Site	Donetsk		Ukraine	83099
160	Investigational Site	Ivano-Frankivsk		Ukraine	76025
161	Investigational Site	Kharkiv		Ukraine	61018
162	Investigational Site	Kharkiv		Ukraine	61035
163	Inestigational Site	Kyiv		Ukraine	02091
164	Investigational Site	Kyiv		Ukraine	03680
165	Investigational Site	Lugansk		Ukraine	91045
166	Investigational Site	Odesa		Ukraine	65025
167	Investigational Site	Poltava		Ukraine	36038
168	Investigational Site	Uzhorod		Ukraine	88015

Sponsors and Collaborators

• Forest Laboratories

Investigators

• Study Director: Thomas M File, MD, MS, Summa Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Forest Laboratories
• ClinicalTrials.gov Identifier: NCT00621504
• Other Study ID Numbers: P903-08
• First Posted: Feb 22, 2008
• Last Update Posted: Mar 14, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Forest Laboratories: ceftaroline; Community-acquired pneumonia; CAP; IV (intravenous); Streptococcus pneumoniae; Haemophilus influenzae; Mycoplasma pneumoniae; Chlamydophila spp; Legionella spp; Multi-drug resistant Streptococcus pneumoniae (MDRSP); antimicrobial resistance; pneumococci; Ceftriaxone; bacteria; ß-lactam; beta-lactam; antibiotic
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Bacterial; Clarithromycin; Ceftriaxone; Ceftaroline fosamil

Study Results

Participant Flow

Recruitment Details	The enrollment period was from 02 January 2008 to 29 December 2008
Pre-assignment Detail	Patients were screened for up to 24 hours

Arm/Group Title	Ceftaroline Fosamil for Injection	IV Ceftriaxone
Arm/Group Description	Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)	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).
Period Title: Overall Study
STARTED	299	307
COMPLETED	273	282
NOT COMPLETED	26	25

Baseline Characteristics

Arm/Group Title	Ceftaroline Fosamil for Injection	IV Ceftriaxone	Total
Arm/Group Description	Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)	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 of all reporting groups
Overall Participants	299	307	606
Age, Customized (participants) [Number]
<65 years	154 51.5%	157 51.1%	311 51.3%
>= 65 years	145 48.5%	150 48.9%	295 48.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.0 (16.6)	61.0 (16.6)	61.0 (16.6)
Sex: Female, Male (Count of Participants)
Female	108 36.1%	112 36.5%	220 36.3%
Male	191 63.9%	195 63.5%	386 63.7%
Race/Ethnicity, Customized (participants) [Number]
Hispanic	29 9.7%	27 8.8%	56 9.2%
Non-Hispanic	270 90.3%	280 91.2%	550 90.8%

Outcome Measures

1. Primary Outcome

Title	Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations
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 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
Time Frame	8 to 15 days after last dose of study drug

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ceftaroline Fosamil for Injection	IV Ceftriaxone
Arm/Group Description	Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)	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).
Measure Participants	291	300
Clinical Cure	244 81.6%	233 75.9%
Clinical Failure	34 11.4%	58 18.9%
Indeterminate	13 4.3%	9 2.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ceftaroline Fosamil for Injection, IV Ceftriaxone
	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 and MITTE Populations in adult subjects with CABP.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on each of the CE and the MITTE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for each of the CE and MITTE Populations.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	6.2
	Confidence Interval	(2-Sided) 95%; -0.2 to 12.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.

2. Secondary Outcome

Title	Clinical Response at End of Therapy (EOT)
Time Frame	Last day of study drug administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Microbiological Success Rate at Test of Cure (TOC)
Time Frame	8-15 days after last dose of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)
Time Frame	8-15 days after last day of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Clinical and Microbiological Response by Pathogen at TOC
Time Frame	8-15 days after last dose of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Clinical Relapse at Late Follow Up (LFU)
Time Frame	21-35 days after last dose of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Primary Outcome

Title	Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population
Time Frame	8-15 days after last dose of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Microbiological Re-infection/Recurrence at LFU
Time Frame	21 to 35 days after last dose of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Evaluate Safety
Time Frame	first dose, throughout the treatment period, and up to the TOC visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Adverse Event Reporting Description	Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug
Arm/Group Title	Ceftaroline Fosamil for Injection		IV Ceftriaxone
Arm/Group Description	Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)		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).
All Cause Mortality
	Ceftaroline Fosamil for Injection		IV Ceftriaxone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ceftaroline Fosamil for Injection		IV Ceftriaxone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/298 (9.4%)		33/308 (10.7%)
Blood and lymphatic system disorders
Anemia	1/298 (0.3%)	1	0/308 (0%)	0
Lymphadenitis	1/298 (0.3%)	1	0/308 (0%)	0
Cardiac disorders
Cardiac failure	1/298 (0.3%)	1	0/308 (0%)	0
Left ventricular failure	1/298 (0.3%)	1	0/308 (0%)	0
Ventricular tachycardia	1/298 (0.3%)	1	0/308 (0%)	0
Cardiac failure acute	0/298 (0%)	0	1/308 (0.3%)	1
Cardiac failure congestive	0/298 (0%)	0	1/308 (0.3%)	1
Cardio-respiratory arrest	0/298 (0%)	0	1/308 (0.3%)	1
Cardiomyopathy	0/298 (0%)	0	1/308 (0.3%)	1
Cardiopulmonary failure	0/298 (0%)	0	1/308 (0.3%)	1
Myocardial infarction	0/298 (0%)	0	1/308 (0.3%)	1
Ischemic cardiomyopathy	1/298 (0.3%)	1	0/308 (0%)	0
Gastrointestinal disorders
Gastritis	1/298 (0.3%)	1	0/308 (0%)	0
Gastrointestinal perforation	1/298 (0.3%)	1	0/308 (0%)	0
General disorders
Sudden death	2/298 (0.7%)	2	0/308 (0%)	0
Multiorgan disorder	0/298 (0%)	0	1/308 (0.3%)	1
Hepatobiliary disorders
Acute hepatic failure	0/298 (0%)	0	1/308 (0.3%)	1
Cholecystitis acute	0/298 (0%)	0	2/308 (0.6%)	2
Hepatic failure	0/298 (0%)	0	1/308 (0.3%)	1
Immune system disorders
Hypersensitivity	0/298 (0%)	0	1/308 (0.3%)	1
Infections and infestations
Pneumonia	2/298 (0.7%)	2	5/308 (1.6%)	5
Bronchitis	1/298 (0.3%)	1	0/308 (0%)	0
Empyema	1/298 (0.3%)	1	2/308 (0.6%)	2
Pyothorax	1/298 (0.3%)	1	0/308 (0%)	0
Sepsis	1/298 (0.3%)	1	0/308 (0%)	0
Tuberculosis	1/298 (0.3%)	1	0/308 (0%)	0
Cellulitis	0/298 (0%)	0	1/308 (0.3%)	1
Endocarditis	0/298 (0%)	0	1/308 (0.3%)	1
Gastroenteritis	0/298 (0%)	0	2/308 (0.6%)	2
Lung abscess	0/298 (0%)	0	1/308 (0.3%)	1
Pulmonary tuberculosis	0/298 (0%)	0	1/308 (0.3%)	1
Urosepsis	0/298 (0%)	0	1/308 (0.3%)	1
Investigations
Liver function test abnormal	1/298 (0.3%)	1	0/308 (0%)	0
Metabolism and nutrition disorders
Diabetes mellitus	1/298 (0.3%)	1	1/308 (0.3%)	1
Gout	0/298 (0%)	0	1/308 (0.3%)	1
Type 1 diabetes mellitus	0/298 (0%)	0	1/308 (0.3%)	1
Type 2 diabetes mellitus	0/298 (0%)	0	1/308 (0.3%)	1
Musculoskeletal and connective tissue disorders
Myopathy	0/298 (0%)	0	1/308 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma	1/298 (0.3%)	1	0/308 (0%)	0
Lung neoplasm	1/298 (0.3%)	1	0/308 (0%)	0
Metastases to liver	1/298 (0.3%)	1	0/308 (0%)	0
Pancreatic neoplasm	1/298 (0.3%)	1	0/308 (0%)	0
Small cell lung cancer, state unspecified	1/298 (0.3%)	1	0/308 (0%)	0
Lung adenocarcinoma metastatic	0/298 (0%)	0	1/308 (0.3%)	1
Nervous system disorders
Thrombotic stroke	1/298 (0.3%)	1	0/308 (0%)	0
Renal and urinary disorders
Urinary retention	0/298 (0%)	0	1/308 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure	2/298 (0.7%)	2	1/308 (0.3%)	1
Pleural effusion	1/298 (0.3%)	1	1/308 (0.3%)	1
Pulmonary embolism	1/298 (0.3%)	1	1/308 (0.3%)	1
Asthma	0/298 (0%)	0	2/308 (0.6%)	2
Chronic obstructive pulmonary disease	0/298 (0%)	0	1/308 (0.3%)	1
Vascular disorders
Aortic aneurysm	1/298 (0.3%)	1	0/308 (0%)	0
Aortic dissection	1/298 (0.3%)	1	0/308 (0%)	0
Deep vein thrombosis	0/298 (0%)	0	1/308 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Ceftaroline Fosamil for Injection		IV Ceftriaxone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	65/298 (21.8%)		53/308 (17.2%)
Gastrointestinal disorders
Diarrhea	14/298 (4.7%)	14	7/308 (2.3%)	7
Nausea	8/298 (2.7%)	8	8/308 (2.6%)	8
Constipation	7/298 (2.3%)	7	5/308 (1.6%)	5
Metabolism and nutrition disorders
Hypokalemia	4/298 (1.3%)	4	10/308 (3.2%)	10
Nervous system disorders
Headache	10/298 (3.4%)	10	4/308 (1.3%)	4
Psychiatric disorders
Insomnia	9/298 (3%)	9	6/308 (1.9%)	6
Vascular disorders
Phlebitis	7/298 (2.3%)	7	5/308 (1.6%)	5
Hypertension	6/298 (2%)	6	8/308 (2.6%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.