Trial Outcomes & Findings for Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections (NCT NCT00424190)

Last Updated: 2017-03-14

Results Overview

Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary. Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI. Indeterminate: Inability to determine an outcome

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

698 participants

Primary outcome timeframe

8-15 days after the end of treatment

Results posted on

2017-03-14

Participant Flow

Patients were recruited worldwide from February 2007 to November 2007

Patients were screened for up to 24 hours

Participant milestones

Participant milestones
Measure	Ceftaroline Fosamil for Injection Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours	IV Vancomycin Plus IV Aztreonam Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
Overall Study STARTED	351	347
Overall Study COMPLETED	329	317
Overall Study NOT COMPLETED	22	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Ceftaroline Fosamil for Injection Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours	IV Vancomycin Plus IV Aztreonam Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
Overall Study Withdrew consent	3	4
Overall Study Death	3	0
Overall Study Noncompliance	1	2
Overall Study Request of sponsor or investigator	0	2
Overall Study Diagnosis of osteomyelitis	0	1
Overall Study Other	15	21

Baseline Characteristics

Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ceftaroline Fosamil for Injection n=351 Participants Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours	IV Vancomycin Plus IV Aztreonam n=347 Participants Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours	Total n=698 Participants Total of all reporting groups
Age, Continuous	49.2 years STANDARD_DEVIATION 17.17 • n=5 Participants	47.2 years STANDARD_DEVIATION 17.01 • n=7 Participants	48.2 years STANDARD_DEVIATION 17.10 • n=5 Participants
Age, Customized >=65 years	57 participants n=5 Participants	72 participants n=7 Participants	129 participants n=5 Participants
Age, Customized <18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized >=18 years and < 65 years	294 participants n=5 Participants	275 participants n=7 Participants	569 participants n=5 Participants
Sex: Female, Male Female	131 Participants n=5 Participants	129 Participants n=7 Participants	260 Participants n=5 Participants
Sex: Female, Male Male	220 Participants n=5 Participants	218 Participants n=7 Participants	438 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	268 participants n=5 Participants	270 participants n=7 Participants	538 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	83 participants n=5 Participants	77 participants n=7 Participants	160 participants n=5 Participants

PRIMARY outcome

Timeframe: 8-15 days after the end of treatment

Population: MITT (Modified Intent to Treat) - Any randomized subjects that received any amount of study drug

Outcome measures

Outcome measures
Measure	Ceftaroline Fosamil for Injection n=351 Participants Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours	IV Vancomycin Plus IV Aztreonam n=347 Participants Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
Clinical Cure Rate at Test of Cure (TOC) (MITT Population) Clinical Cure	304 participants	297 participants
Clinical Cure Rate at Test of Cure (TOC) (MITT Population) Clinical Failure	29 participants	21 participants
Clinical Cure Rate at Test of Cure (TOC) (MITT Population) Indeterminate	18 participants	29 participants

PRIMARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Last day of study drug administration

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 21 to 35 days after the last dose of study drug

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 21 to 35 days after the last dose of study drug

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First dose of study drug through TOC visit

Comparisons of the number of participants with Adverse Events

Outcome measures

Outcome data not reported

Adverse Events

Ceftaroline Fosamil for Injection

Serious events: 16 serious events

Other events: 128 other events

Deaths: 0 deaths

IV Vancomycin Plus IV Aztreonam

Serious events: 12 serious events

Other events: 162 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Vice President, Clinical Sciences

Cerexa

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=351 participants at risk Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours	IV Vancomycin Plus IV Aztreonam n=347 participants at risk Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
Cardiac disorders Cardiac failure congestive	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Cardiac disorders Cardiopulmonary failure	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Cardiac disorders Coronary artery disease	0.00% 0/351 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Gastrointestinal disorders Constipation	0.00% 0/351 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Gastrointestinal disorders Hematochezia	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Gastrointestinal disorders Intestinal ischemia	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Gastrointestinal disorders Peptic ulcer hemorrhage	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
General disorders Generalized edema	0.00% 0/351 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Immune system disorders Hypersensitivity	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Infections and infestations Cellulitis	0.57% 2/351 • Number of events 2 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Infections and infestations Clostridial infection	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Infections and infestations Osteomyelitis	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Infections and infestations Renal abscess	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Infections and infestations Viral infection	0.00% 0/351 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Infections and infestations Wound infection	0.00% 0/351 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Investigations Electrocardiogram ST segment elevation	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Metabolism and nutrition disorders Hyperglycemia	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Musculoskeletal and connective tissue disorders Back pain	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/351 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Nervous system disorders Cerebrovascular accident	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Nervous system disorders Syncope	0.00% 0/351 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Nervous system disorders Transient ischemic attack	0.00% 0/351 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.00% 0/347 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Vascular disorders Arterial thrombosis limb	0.00% 0/351 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	0.29% 1/347 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.

Measure	Ceftaroline Fosamil for Injection n=351 participants at risk Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours	IV Vancomycin Plus IV Aztreonam n=347 participants at risk Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
Gastrointestinal disorders Nausea	5.7% 20/351 • Number of events 20 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	4.6% 16/347 • Number of events 16 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Nervous system disorders Headache	5.1% 18/351 • Number of events 18 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	3.7% 13/347 • Number of events 13 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Skin and subcutaneous tissue disorders Pruritus generalized	3.7% 13/351 • Number of events 13 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	4.6% 16/347 • Number of events 16 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Gastrointestinal disorders Diarrhea	3.4% 12/351 • Number of events 12 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	3.2% 11/347 • Number of events 11 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Skin and subcutaneous tissue disorders Rash	3.4% 12/351 • Number of events 12 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	2.3% 8/347 • Number of events 8 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Skin and subcutaneous tissue disorders Pruritus	3.1% 11/351 • Number of events 11 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	8.4% 29/347 • Number of events 29 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Gastrointestinal disorders Vomiting	2.6% 9/351 • Number of events 9 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	2.6% 9/347 • Number of events 9 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Gastrointestinal disorders Constipation	2.3% 8/351 • Number of events 8 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	1.7% 6/347 • Number of events 6 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Nervous system disorders Dizziness	2.3% 8/351 • Number of events 8 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	1.7% 6/347 • Number of events 6 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Psychiatric disorders Insomnia	1.4% 5/351 • Number of events 5 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	2.6% 9/347 • Number of events 9 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
General disorders Pyrexia	1.1% 4/351 • Number of events 4 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	2.6% 9/347 • Number of events 9 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Skin and subcutaneous tissue disorders Erythema	0.85% 3/351 • Number of events 3 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	2.6% 9/347 • Number of events 9 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Investigations Aspartate aminotransferase increased	0.85% 3/351 • Number of events 3 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	2.0% 7/347 • Number of events 7 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
General disorders Fatigue	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	2.0% 7/347 • Number of events 7 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.
Vascular disorders Hypertension	0.28% 1/351 • Number of events 1 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.	2.0% 7/347 • Number of events 7 All safety analysis was performed on the Safety Population, those subjects that had received any amount of the actual study drug.