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

• Sponsor: Forest Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00509106
• Collaborator: (none)
• Enrollment: 622
• Locations: 135
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

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

Detailed Description

Clinical trials is being held in different countries. The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Study Design

• Study Type: Interventional
• Actual Enrollment: 622 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 in the Treatment of Adult Subjects With Community-Acquired Pneumonia
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Aug 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).	Drug: Ceftaroline fosamil for Injection; 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days; Other Names: Experimental
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).	Drug: Ceftriaxone; 1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days; Other Names: Active comparator ; 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

Outcome Measures

Primary Outcome Measures

1. Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population [8-15 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 With That for Ceftriaxone at 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 TOC [8-15 days after last dose of study drug]

3. Overall Clinical and Radiographic Success Rate at TOC [8-15 days after last dose 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) Visit [21-35 days after last dose of study drug]

6. Microbiological Reinfection/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 with community-acquired pneumonia requiring:

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

• infection requiring initial treatment with IV antimicrobial

Exclusion Criteria:

• Community-acquired pneumonia suitable for outpatient therapy with an oral antimicrobial agent

• Respiratory tract infections not due to community-acquired bacterial pathogens

• Infections resistant to ceftriaxone

• Any condition requiring concomitant systemic corticosteroids

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site	Durham	North Carolina	United States	27710
2	Investigational Site	Autonoma	Buenos Aires	Argentina	B1722FJN
3	Investigational Site	Mar del Plata	Buenos Aires	Argentina	7600
4	Investigational Site	Merlo	Buenos Aires	Argentina	B1722FJN
5	Investigational Site	Buenos Aires		Argentina	174
6	Investigational Site	Buenos Aires		Argentina	B1602DOH
7	Investigational Site	Buenos Aires		Argentina	B1657BHD
8	Investigational Site	Buenos Aires		Argentina	B1870CID
9	Investigational Site	Buenos Aires		Argentina	B1902AVG
10	Investigational Site	Buenos Aires		Argentina	B8000AAT
11	Investigational Site	Buenos Aires		Argentina	C1039AAO
12	Investigational Site	Buenos Aires		Argentina	C1180AAX
13	Invetigational Site	Buenos Aires		Argentina
14	Investigational Site	Cordoba		Argentina	520
15	Investigational Site	Cordoba		Argentina	X5000HGX
16	Investigational Site	Cordoba		Argentina	X5000JQB
17	INvestigational Site	Cordoba		Argentina	X5000JRD
18	Investigational Site	Cordoba		Argentina	X5004CDT
19	Investigational Site	Entre Rios		Argentina	E3100BBJ
20	Investigational Site	Granadero Baiggoria		Argentina	S152EDD
21	Investigational Site	Parana		Argentina	E3100BBJ
22	Investigational Site	Santa Fe		Argentina	S2152EDD
23	Investigational Site	Santa Fe		Argentina	S3000EOY
24	Investigational site	Grieskirchner	Wels	Austria	4600
25	Investigational Site	Steyr		Austria	4400
26	Investigational Site	Wels		Austria	42
27	Investigational Site	Wien		Austria	1141
28	Investigational Site	Plovdiv		Bulgaria	4002
29	Investigational Site	Rousse		Bulgaria	7000
30	Investigational Site	Sofia		Bulgaria	1233
31	Investigational Site	Sofia		Bulgaria	1431
32	Investigational Site	Sofia		Bulgaria	1606
33	Investigational Site	Sofia		Bulgaria	1784
34	Investigational Drug	Varna		Bulgaria	9010
35	Investigational Site	San Ignacio	Valparaiso	Chile	725
36	Investigational Site	Santiago		Chile	3 Piso
37	Investigational Site	Santiago		Chile	4 Piso
38	Investigational Site	Santiago		Chile
39	Investigational Site	Talcahuano		Chile
40	Investigational Site	Temuco		Chile
41	Inestigational Site	Valdivia		Chile	Of.5
42	Investigational Site	Valdivia		Chile
43	Investigational Site	Valparaiso		Chile
44	Investigational Site	Aachen		Germany	52057
45	Investigational Site	Aachen		Germany	D-52057
46	Investigational Site	Berlin		Germany	12559
47	Inestigational Site	Berlin		Germany	14165
48	Investigational Site	Berlin		Germany	14165
49	Investigational Site	Berlin		Germany	D-12351
50	Investigational Site	Dachau		Germany	85221
51	Investigational Site	Frankfurt am Main		Germany	60487
52	Investigational Site	Frankfurt		Germany	60487
53	Investigational Site	Greifswald		Germany	17475
54	Investigational Site	Halle/Saale		Germany	06120
55	Investigtional Site	Hannover		Germany	30625
56	Investigational Site	Heidelberg		Germany	69120
57	Investigational Site	Hofheim		Germany	65719
58	Investigational Site	Immenhausen		Germany	34376
59	Investigational Site	Lubeck		Germany	23538
60	Investigational Site	Rotenburg (Wuemme)		Germany	27356
61	Investigational Site	Rotenburg		Germany	27356
62	Investigational Site	Wuppertal		Germany	42283
63	Investigational Site	Gyor		Hungary	9023
64	Investigational Site	Nyiregyhaza		Hungary	4400
65	Investigational Site	Nyiregyhaza		Hungary	4412
66	Investigational Site	Seregelyesi		Hungary	ut3
67	Investigational Site	Sostoi		Hungary	ut.62
68	Investigational Site	Szekesfehervar		Hungary	8000
69	Investigational Site	Szent Instvan		Hungary	u.68
70	Investigational Site	Vasvari Pal		Hungary	u.2
71	Investigational Site	Bangalore		India	560034
72	Investigational Site	Gujarat		India	380054
73	Investigational Site	Karnataka		India	560054
74	Investigational Site	Karnataka		India	575001
75	Investigational Site	Noida		India	201301
76	Investigational Site	Pradesh		India
77	Investigational Site	Daugavpils		Latvia	LV-5417
78	Investigational Site	Latvia		Latvia	LV-1002
79	Investigational Site	Liepaja		Latvia	LV-5417
80	Investigational Site	Riga		Latvia	LV-1001
81	Investigational Site	Chihuahua		Mexico	31238
82	Investigational Site	Chihuahua		Mexico	CP44280
83	Investigational Site	Jalisco		Mexico	44280
84	Investigational Site	Jalisco		Mexico	45170
85	Investigational Site	Jalisco		Mexico	CP44280
86	Investigational Site	Lima		Mexico
87	Investigational Site	Sonora		Mexico	83000
88	Investigational Site	Lima		Peru	1
89	Investigational Site	Lima		Peru	31
90	Investigator Site	Bialystok		Poland	15-540
91	Investigational Site	Bystra		Poland	43-360
92	Investigational Site	Chrzanow		Poland	32-500
93	Investigational Site	Krakow		Poland	31-066
94	Investigational Site	Krakow		Poland	31-202
95	Investigtional Site	Krakow		Poland	31-202
96	Investigational Site	Krakow		Poland	31-531
97	Investigational Site	Lodz		Poland	90-153
98	Investigational Site	Lodz		Poland	91-520
99	Investigational Site	Lublin		Poland	20-954
100	Investigational Site	Poznan		Poland	60-531
101	Investigational Site	Poznan		Poland	60-569
102	Investigational Site	Skierniewice		Poland	96-100
103	Inestigational Site	Warszawa		Poland	00-909
104	Investigational Site	Warszawa		Poland	00-909
105	Investigational Site	Warszawa		Poland	01-138
106	Investigational Site	Warszawa		Poland	02-097
107	Investigational Site	Warszawa		Poland	04-073
108	Investigational Site	Wilkowice-Bystra		Poland	43-365
109	Investigational Site	Wroclaw		Poland	50-417
110	Investigational Site	Zabrze		Poland	41-800
111	Investigational Site	Zabrze		Poland	41-803
112	Investigational Site	Bucharest		Romania	010825
113	Investigational Site	Bucharest		Romania	030303
114	Investigational Site	Bucharest		Romania	050098
115	Investigational Site	Bucharest		Romania	21659
116	Investigational Site	Craiova		Romania	200515
117	Investigational Site	Moscow		Russian Federation	109240
118	Investigational Site	Moscow		Russian Federation	111020
119	Investigational Site	Moscow		Russian Federation	115446
120	Investigational Site	Smolensk		Russian Federation	214019
121	Investigational Site	St. Petersburg		Russian Federation	191015
122	Investigational Site	St. Petersburg		Russian Federation	191180
123	Investigational Site	St. Petersburg		Russian Federation	194017
124	Investigational Site	St. Petersburg		Russian Federation	194291
125	Investigational Site	St. Petersburg		Russian Federation	194354
126	Investigational Site	ST. Petersburg		Russian Federation	197022
127	Investigational Site	Yaroslavl		Russian Federation	150062
128	Investigational Site	Dnipropetrovsk		Ukraine	49044
129	Investigational Site	Kharkiv		Ukraine	61039
130	Investigational site	Kyiv		Ukraine	01133
131	Investigational Site	Kyiv		Ukraine	03115
132	Investigational site	Kyiv		Ukraine	03680
133	Investigational Site	Vinnytsya		Ukraine	21000
134	Investigational Site	Zaporizhya		Ukraine	69035
135	Investigational Site	Zhytomyr		Ukraine	10002

Sponsors and Collaborators

• Forest Laboratories

Investigators

• Principal Investigator: IM Hoepelman, MD, UMC Utrecht

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Forest Laboratories
• ClinicalTrials.gov Identifier: NCT00509106
• Other Study ID Numbers: P903-09
• First Posted: Jul 31, 2007
• Last Update Posted: Mar 14, 2017
• Last Verified: Feb 1, 2017

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

Study Results

Participant Flow

Recruitment Details	Patients were recruited worldwide from July 2007 to August 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	315	307
COMPLETED	284	278
NOT COMPLETED	31	29

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	315	307	622
Age, Customized (participants) [Number]
<65 years	183 58.1%	173 56.4%	356 57.2%
>=65 years	132 41.9%	134 43.6%	266 42.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.0 (17.0)	60.0 (15.5)	59.5 (16.3)
Sex: Female, Male (Count of Participants)
Female	126 40%	105 34.2%	231 37.1%
Male	189 60%	202 65.8%	391 62.9%

Outcome Measures

1. Primary Outcome

Title	Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population
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	8-15 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	315	307
Clinical cure	235 74.6%	206 67.1%
Clinical failure	47 14.9%	56 18.2%
Indeterminate	7 2.2%	11 3.6%

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 with that for ceftriaxone at TOC in the MITTE Population 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 the MITTE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for the MITTE populations.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.9
	Confidence Interval	(2-Sided) 95%; -1.0 to 12.7
	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. Primary Outcome

Title	Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at 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

3. 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

4. Secondary Outcome

Title	Microbiological Success Rate 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

5. Secondary Outcome

Title	Overall Clinical and Radiographic Success Rate 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 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

7. Secondary Outcome

Title	Clinical Relapse at Late Follow Up (LFU) Visit
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

8. Secondary Outcome

Title	Microbiological Reinfection/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	All safety analysis was performed on the Safety Population, those subjects that had 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	41/315 (13%)		39/307 (12.7%)
Blood and lymphatic system disorders
Disseminated intravascular coagulation	1/315 (0.3%)	1	0/307 (0%)	0
Cardiac disorders
Cardiac arrest	1/315 (0.3%)	1	0/307 (0%)	0
Cardiac failure congestive	1/315 (0.3%)	1	0/307 (0%)	0
Cardiopulmonary failure	1/315 (0.3%)	1	0/307 (0%)	0
Acute myocardial infarction	0/315 (0%)	0	1/307 (0.3%)	1
Atrioventricular block complete	0/315 (0%)	0	1/307 (0.3%)	1
Cardio-respiratory arrest	0/315 (0%)	0	1/307 (0.3%)	1
Coronary artery disease	0/315 (0%)	0	1/307 (0.3%)	1
Myocardial infarction	0/315 (0%)	0	1/307 (0.3%)	1
Postinfarction angina	0/315 (0%)	0	1/307 (0.3%)	1
Endocrine disorders
Hypothyroidism	1/315 (0.3%)	1	0/307 (0%)	0
Gastrointestinal disorders
Duodenal ulcer	1/315 (0.3%)	1	0/307 (0%)	0
Gastric ulcer	0/315 (0%)	0	1/307 (0.3%)	1
Volvulus	0/315 (0%)	0	1/307 (0.3%)	1
Hepatobiliary disorders
Hepatic failure	1/315 (0.3%)	1	0/307 (0%)	0
Infections and infestations
Pneumonia	7/315 (2.2%)	7	4/307 (1.3%)	4
Pyothorax	3/315 (1%)	3	0/307 (0%)	0
Lung abscess	2/315 (0.6%)	2	3/307 (1%)	3
Urinary tract infection	2/315 (0.6%)	2	1/307 (0.3%)	1
Cellulitis	1/315 (0.3%)	1	0/307 (0%)	0
Sepsis	1/315 (0.3%)	1	1/307 (0.3%)	1
Septic shock	1/315 (0.3%)	1	0/307 (0%)	0
Endocarditis	0/315 (0%)	0	1/307 (0.3%)	1
Hepatitis C	0/315 (0%)	0	1/307 (0.3%)	1
Lung infection pseudomonal	0/315 (0%)	0	1/307 (0.3%)	1
Staphylococcal bactgeraemia	0/315 (0%)	0	1/307 (0.3%)	1
Investigations
Hepatic enzyme increased	0/315 (0%)	0	1/307 (0.3%)	1
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	1/315 (0.3%)	1	0/307 (0%)	0
Hypoglycaemia	1/315 (0.3%)	1	0/307 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	3/315 (1%)	3	0/307 (0%)	0
Colon cancer	1/315 (0.3%)	1	0/307 (0%)	0
Malignant neoplasm progression	1/315 (0.3%)	1	0/307 (0%)	0
Metastatic neoplasm	1/315 (0.3%)	1	0/307 (0%)	0
Renal neoplasm	1/315 (0.3%)	1	0/307 (0%)	0
Multiple myeloma	0/315 (0%)	0	1/307 (0.3%)	1
Prostate cancer	0/315 (0%)	0	1/307 (0.3%)	1
Nervous system disorders
Anoxic encephalopathy	1/315 (0.3%)	1	0/307 (0%)	0
Convulsion	1/315 (0.3%)	1	0/307 (0%)	0
Toxic encephalopathy	1/315 (0.3%)	1	0/307 (0%)	0
Cerebrovascular accident	0/315 (0%)	0	1/307 (0.3%)	1
Hemiplegia	0/315 (0%)	0	1/307 (0.3%)	1
Renal and urinary disorders
Renal failure	2/315 (0.6%)	2	0/307 (0%)	0
Hydronephrosis	0/315 (0%)	0	1/307 (0.3%)	1
Reproductive system and breast disorders
Epididymitis	0/315 (0%)	0	1/307 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	4/315 (1.3%)	4	5/307 (1.6%)	5
Pleural effusion	4/315 (1.3%)	4	5/307 (1.6%)	5
Pulmonary embolism	4/315 (1.3%)	4	3/307 (1%)	3
Pulmonary oedema	2/315 (0.6%)	2	0/307 (0%)	0
Respiratory failure	2/315 (0.6%)	2	0/307 (0%)	0
Interstitial lung disease	1/315 (0.3%)	1	0/307 (0%)	0
Pleurisy	1/315 (0.3%)	1	2/307 (0.7%)	2
Acute pulmonary oedema	0/315 (0%)	0	1/307 (0.3%)	1
Acute respiratory failure	0/315 (0%)	0	1/307 (0.3%)	1
Asthma	0/315 (0%)	0	1/307 (0.3%)	1
Asthmatic crisis	0/315 (0%)	0	1/307 (0.3%)	1
Atelectasis	0/315 (0%)	0	1/307 (0.3%)	1
Vascular disorders
Cardiovascular insufficiency	1/315 (0.3%)	1	0/307 (0%)	0
Peripheral ischaemia	1/315 (0.3%)	1	0/307 (0%)	0
Hypertensive crisis	0/315 (0%)	0	1/307 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Ceftaroline Fosamil for Injection		IV Ceftriaxone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	67/315 (21.3%)		49/307 (16%)
Gastrointestinal disorders
Diarrhea	12/315 (3.8%)	12	9/307 (2.9%)	9
Nausea	6/315 (1.9%)	6	6/307 (2%)	6
Metabolism and nutrition disorders
Hypokalemia	10/315 (3.2%)	10	5/307 (1.6%)	5
Nervous system disorders
Headache	11/315 (3.5%)	11	5/307 (1.6%)	5
Psychiatric disorders
Insomnia	10/315 (3.2%)	10	8/307 (2.6%)	8
Vascular disorders
Hypertension	8/315 (2.5%)	8	8/307 (2.6%)	8
Phlebitis	10/315 (3.2%)	10	8/307 (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.