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

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: NCT00509106
Recruitment Status : Completed
First Posted : July 31, 2007
Results First Posted : November 7, 2010
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
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 Pneumonia
Interventions Drug: Ceftaroline fosamil for Injection
Drug: Ceftriaxone
Drug: Placebo
Enrollment 622
Recruitment Details Patients were recruited worldwide from July 2007 to August 2008
Pre-assignment Details Patients were screened for up to 24 hours
Arm/Group Title Ceftaroline Fosamil for Injection IV Ceftriaxone
Hide 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
Reason Not Completed
Adverse Event             3             2
Noncompliance             0             1
At the request of sponsor/investigator             1             2
Withdrew consent             4             8
Lost to Follow-up             16             10
Other             1             0
Death             6             6
Arm/Group Title Ceftaroline Fosamil for Injection IV Ceftriaxone Total
Hide 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 Number of Baseline Participants 315 307 622
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 315 participants 307 participants 622 participants
<65 years 183 173 356
>=65 years 132 134 266
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 315 participants 307 participants 622 participants
59.0  (17.0) 60.0  (15.5) 59.5  (16.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 315 participants 307 participants 622 participants
Female
126
  40.0%
105
  34.2%
231
  37.1%
Male
189
  60.0%
202
  65.8%
391
  62.9%
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 315 307
Measure Type: Number
Unit of Measure: participants
Clinical cure 235 206
Clinical failure 47 56
Indeterminate 7 11
Hide 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.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 5.9
Confidence Interval (2-Sided) 95%
-1.0 to 12.7
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
Hide Description [Not Specified]
Time Frame 8-15 days after last dose of study drug
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Clinical Response at End of Therapy (EOT)
Hide Description [Not Specified]
Time Frame Last day of study drug administration
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Microbiological Success Rate at TOC
Hide Description [Not Specified]
Time Frame 8-15 days after last dose of study drug
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Clinical and Radiographic Success Rate at TOC
Hide Description [Not Specified]
Time Frame 8-15 days after last dose of study drug
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Clinical and Microbiological Response by Pathogen at TOC
Hide Description [Not Specified]
Time Frame 8-15 days after last dose of study drug
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Clinical Relapse at Late Follow Up (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 Microbiological Reinfection/Recurrence at LFU
Hide Description [Not Specified]
Time Frame 21 to 35 days after last dose of study drug
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Evaluate Safety
Hide Description [Not Specified]
Time Frame first dose, throughout the treatment period, and up to the TOC visit
Outcome Measure Data Not Reported
Time Frame [Not Specified]
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
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ceftaroline Fosamil for Injection IV Ceftriaxone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/315 (13.02%)      39/307 (12.70%)    
Blood and lymphatic system disorders     
Disseminated intravascular coagulation  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Cardiac disorders     
Cardiac arrest  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Cardiac failure congestive  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Cardiopulmonary failure  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Acute myocardial infarction  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Atrioventricular block complete  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Cardio-respiratory arrest  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Coronary artery disease  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Myocardial infarction  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Postinfarction angina  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Endocrine disorders     
Hypothyroidism  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Gastrointestinal disorders     
Duodenal ulcer  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Gastric ulcer  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Volvulus  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Hepatobiliary disorders     
Hepatic failure  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Infections and infestations     
Pneumonia  1  7/315 (2.22%)  7 4/307 (1.30%)  4
Pyothorax  1  3/315 (0.95%)  3 0/307 (0.00%)  0
Lung abscess  1  2/315 (0.63%)  2 3/307 (0.98%)  3
Urinary tract infection  1  2/315 (0.63%)  2 1/307 (0.33%)  1
Cellulitis  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Sepsis  1  1/315 (0.32%)  1 1/307 (0.33%)  1
Septic shock  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Endocarditis  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Hepatitis C  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Lung infection pseudomonal  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Staphylococcal bactgeraemia  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Investigations     
Hepatic enzyme increased  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Hypoglycaemia  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant  1  3/315 (0.95%)  3 0/307 (0.00%)  0
Colon cancer  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Malignant neoplasm progression  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Metastatic neoplasm  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Renal neoplasm  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Multiple myeloma  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Prostate cancer  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Nervous system disorders     
Anoxic encephalopathy  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Convulsion  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Toxic encephalopathy  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Cerebrovascular accident  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Hemiplegia  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Renal and urinary disorders     
Renal failure  1  2/315 (0.63%)  2 0/307 (0.00%)  0
Hydronephrosis  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Reproductive system and breast disorders     
Epididymitis  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  4/315 (1.27%)  4 5/307 (1.63%)  5
Pleural effusion  1  4/315 (1.27%)  4 5/307 (1.63%)  5
Pulmonary embolism  1  4/315 (1.27%)  4 3/307 (0.98%)  3
Pulmonary oedema  1  2/315 (0.63%)  2 0/307 (0.00%)  0
Respiratory failure  1  2/315 (0.63%)  2 0/307 (0.00%)  0
Interstitial lung disease  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Pleurisy  1  1/315 (0.32%)  1 2/307 (0.65%)  2
Acute pulmonary oedema  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Acute respiratory failure  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Asthma  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Asthmatic crisis  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Atelectasis  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Vascular disorders     
Cardiovascular insufficiency  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Peripheral ischaemia  1  1/315 (0.32%)  1 0/307 (0.00%)  0
Hypertensive crisis  1  0/315 (0.00%)  0 1/307 (0.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Ceftaroline Fosamil for Injection IV Ceftriaxone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/315 (21.27%)      49/307 (15.96%)    
Gastrointestinal disorders     
Diarrhea  1  12/315 (3.81%)  12 9/307 (2.93%)  9
Nausea  1  6/315 (1.90%)  6 6/307 (1.95%)  6
Metabolism and nutrition disorders     
Hypokalemia  1  10/315 (3.17%)  10 5/307 (1.63%)  5
Nervous system disorders     
Headache  1  11/315 (3.49%)  11 5/307 (1.63%)  5
Psychiatric disorders     
Insomnia  1  10/315 (3.17%)  10 8/307 (2.61%)  8
Vascular disorders     
Hypertension  1  8/315 (2.54%)  8 8/307 (2.61%)  8
Phlebitis  1  10/315 (3.17%)  10 8/307 (2.61%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00509106    
Other Study ID Numbers: P903-09
First Submitted: July 27, 2007
First Posted: July 31, 2007
Results First Submitted: October 12, 2010
Results First Posted: November 7, 2010
Last Update Posted: March 14, 2017