CAP: Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia
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 |
---|---|---|
|
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
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:
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
- 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
- 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
- Clinical Response at End of Therapy (EOT) [Last day of study drug administration]
- Microbiological Success Rate at Test of Cure (TOC) [8-15 days after last dose of study drug]
- Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) [8-15 days after last day of study drug]
- Clinical and Microbiological Response by Pathogen at TOC [8-15 days after last dose of study drug]
- Clinical Relapse at Late Follow Up (LFU) [21-35 days after last dose of study drug]
- Microbiological Re-infection/Recurrence at LFU [21 to 35 days after last dose of study drug]
- Evaluate Safety [first dose, throughout the treatment period, and up to the TOC visit]
Eligibility Criteria
Criteria
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 | |
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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.- P903-08
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
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. |
Title | Clinical Response at End of Therapy (EOT) |
---|---|
Description | |
Time Frame | Last day of study drug administration |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Microbiological Success Rate at Test of Cure (TOC) |
---|---|
Description | |
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 |
Title | Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) |
---|---|
Description | |
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 |
Title | Clinical and Microbiological Response by Pathogen at TOC |
---|---|
Description | |
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 |
Title | Clinical Relapse at Late Follow Up (LFU) |
---|---|
Description | |
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 |
Title | Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population |
---|---|
Description | |
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 |
Title | Microbiological Re-infection/Recurrence at LFU |
---|---|
Description | |
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 |
Title | Evaluate Safety |
---|---|
Description | |
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
Time Frame | ||||
---|---|---|---|---|
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
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.
Results Point of Contact
Name/Title | Vice President, Clinical Sciences |
---|---|
Organization | Cerexa, Inc |
Phone | (510) 285-9200 |
clinicaltrials@cerexa.com |
- P903-08