Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00423657
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : November 18, 2010
Last Update Posted : March 14, 2017
Sponsor:
Information provided by:
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bacterial Infections
Interventions Drug: ceftaroline
Drug: vancomycin plus aztreonam
Drug: Placebo
Enrollment 680
Recruitment Details Patients were recruited worldwide from March 2007 to December 2007
Pre-assignment Details Patients were screened for up to 24 hours
Arm/Group Title Ceftaroline for Injection IV Vancomycin Plus IV Aztreonam
Hide Arm/Group Description Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
Period Title: Overall Study
Started 342 338
Completed 316 313
Not Completed 26 25
Reason Not Completed
Withdrew consent             10             8
Non-compliance             0             1
Other             15             16
Request of sponsor/investigator             1             0
Arm/Group Title Ceftaroline for Injection IV Vancomycin Plus IV Aztreonam Total
Hide Arm/Group Description Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours. Total of all reporting groups
Overall Number of Baseline Participants 342 338 680
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 342 participants 338 participants 680 participants
<=18 years 0 0 0
>18 and < 65 years 281 291 572
>=65 years 61 47 108
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 342 participants 338 participants 680 participants
47.8  (16.98) 47.5  (16.07) 47.7  (16.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 342 participants 338 participants 680 participants
Female
118
  34.5%
137
  40.5%
255
  37.5%
Male
224
  65.5%
201
  59.5%
425
  62.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 342 participants 338 participants 680 participants
Hispanic or Latino
63
  18.4%
59
  17.5%
122
  17.9%
Not Hispanic or Latino
279
  81.6%
279
  82.5%
558
  82.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
Hide Description

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 complicated skin and skin structure infection (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

Time Frame 8-15 days after last dose of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
MITT (Modified Intent to Treat) - all subjects that received any amount of study drug
Arm/Group Title Ceftaroline for Injection IV Vancomycin Plus IV Aztreonam
Hide Arm/Group Description:
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
Overall Number of Participants Analyzed 342 338
Measure Type: Number
Unit of Measure: participants
Clinical Cure 291 289
Clinical Failure 25 28
Indeterminate 26 21
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline for Injection, IV Vancomycin Plus IV Aztreonam
Comments The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.
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 between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95%CI was higher than -10%.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-5.8 to 5.0
Estimation Comments Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.
2.Primary Outcome
Title The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.
Hide Description [Not Specified]
Time Frame 8-15 days after last dose of study drug
Outcome Measure Data Not Reported
3.Secondary Outcome
Title To Evaluate the Microbiological Success Rate at the TOC Visit
Hide Description [Not Specified]
Time Frame 8-15 days after the last dose of study drug
Outcome Measure Data Not Reported
4.Secondary Outcome
Title To Evaluate the Clinical Response at the End of Therapy (EOT) Visit
Hide Description [Not Specified]
Time Frame last day of study drug administration
Outcome Measure Data Not Reported
5.Secondary Outcome
Title To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit
Hide Description [Not Specified]
Time Frame 8-15 days after last dose of study drug
Outcome Measure Data Not Reported
6.Secondary Outcome
Title To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit
Hide Description [Not Specified]
Time Frame 21 to 35 days after the last dose of study drug
Outcome Measure Data Not Reported
7.Secondary Outcome
Title To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit
Hide Description [Not Specified]
Time Frame 21-35 days after last dose of study drug
Outcome Measure Data Not Reported
8.Secondary Outcome
Title To Evaluate Safety
Hide Description [Not Specified]
Time Frame first study drug dose through TOC
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description All safety analyses were performed on the Safety Population which consists of all subjects who received any amount of actual study drug.
 
Arm/Group Title Ceftaroline for Injection IV Vancomycin Plus IV Aztreonam
Hide Arm/Group Description Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
All-Cause Mortality
Ceftaroline for Injection IV Vancomycin Plus IV Aztreonam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ceftaroline for Injection IV Vancomycin Plus IV Aztreonam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/341 (4.11%)      16/339 (4.72%)    
Blood and lymphatic system disorders     
Anemia  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Coagulopathy  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Cardiac disorders     
Bradycardia  1  1/341 (0.29%)  1 1/339 (0.29%)  1
Myocardial infarction  1  1/341 (0.29%)  1 1/339 (0.29%)  1
Sinoatrial block  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Ileus  1  0/341 (0.00%)  0 1/339 (0.29%)  1
General disorders     
Multi-organ failure  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Condition aggravated  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Hepatobiliary disorders     
Hepatitis  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Immune system disorders     
Anaphylactic shock  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Anaphylactoid reaction  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Infections and infestations     
Bacteremia  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Central line infection  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Wound infection  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Osteomyelitis  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Pneumonia  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Sepsis  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Injury, poisoning and procedural complications     
Accidental overdose  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Dislocation of joint prosthesis  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Postprocedural hemorrhage  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chronic lymphocytic leukemia recurrent  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Nervous system disorders     
Convulsion  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Loss of consciousness  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Renal and urinary disorders     
Acute prerenal failure  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Renal failure  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Renal failure acute  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary edema  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Pulmonary embolism  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Acute respiratory failure  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Vascular disorders     
Hypotension  1  1/341 (0.29%)  1 0/339 (0.00%)  0
Thrombophlebitis  1  0/341 (0.00%)  0 1/339 (0.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Ceftaroline for Injection IV Vancomycin Plus IV Aztreonam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   144/341 (42.23%)      159/339 (46.90%)    
Blood and lymphatic system disorders     
Anemia  1  4/341 (1.17%)  4 8/339 (2.36%)  8
Gastrointestinal disorders     
Diarrhea  1  22/341 (6.45%)  22 15/339 (4.42%)  15
Nausea  1  21/341 (6.16%)  21 19/339 (5.60%)  19
Vomiting  1  11/341 (3.23%)  11 9/339 (2.65%)  9
Constipation  1  10/341 (2.93%)  10 11/339 (3.24%)  11
General disorders     
Pyrexia  1  5/341 (1.47%)  5 7/339 (2.06%)  7
Investigations     
Blood pressure increased  1  7/341 (2.05%)  7 4/339 (1.18%)  4
Alanine aminotransferase increase  1  5/341 (1.47%)  5 7/339 (2.06%)  7
Metabolism and nutrition disorders     
Hypokalemia  1  5/341 (1.47%)  5 9/339 (2.65%)  9
Nervous system disorders     
Headache  1  18/341 (5.28%)  18 18/339 (5.31%)  18
Psychiatric disorders     
Insomnia  1  12/341 (3.52%)  12 8/339 (2.36%)  8
Skin and subcutaneous tissue disorders     
Pruritus  1  13/341 (3.81%)  13 28/339 (8.26%)  28
Rash  1  11/341 (3.23%)  11 10/339 (2.95%)  10
Erythema  1  2/341 (0.59%)  2 8/339 (2.36%)  8
Vascular disorders     
Hypertension  1  8/341 (2.35%)  8 3/339 (0.88%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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
Layout table for Results Point of Contact information
Name/Title: Vice President, Clinical Sciences
Organization: Cerexa, Inc.
Phone: (510) 285-9200
EMail: clinicaltrials@cerexa.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Senior Vice President, Clinical Development, Cerexa, Inc
ClinicalTrials.gov Identifier: NCT00423657    
Other Study ID Numbers: P903-07
First Submitted: January 16, 2007
First Posted: January 18, 2007
Results First Submitted: October 12, 2010
Results First Posted: November 18, 2010
Last Update Posted: March 14, 2017