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Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.

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ClinicalTrials.gov Identifier: NCT02202135
Recruitment Status : Terminated (Overall study status is changed to "Terminated" due to low enrollment)
First Posted : July 28, 2014
Results First Posted : March 31, 2016
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Complicated Skin and Soft Tissue Infection
Interventions Drug: Ceftaroline fosamil
Drug: Vancomycin
Drug: Aztreonam
Enrollment 4
Recruitment Details Overall, 4 patients were enrolled from 2 centres in 1 regions in this study. The first patient was enrolled on 15 September 2014 and the last patient last visit was on 02 January 2015.
Pre-assignment Details  
Arm/Group Title Ceftaroline
Hide Arm/Group Description Ceftaroline fosamil 600 mg 120 min
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Ceftaroline
Hide Arm/Group Description Ceftaroline fosamil 600 mg 120 min
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Randomized patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
80.25  (4.875)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Clinical Response at TOC
Hide Description Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention >48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis >=8 days after the first dose.
Time Frame 7 to 20 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized
Arm/Group Title Ceftaroline
Hide Arm/Group Description:
Ceftaroline fosamil 600 mg 120 min
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Participant
Clinical cure 3
Clinical failure 0
Indeterminate 1
Time Frame Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ceftaroline
Hide Arm/Group Description Ceftaroline fosamil 600 mg 120 min
All-Cause Mortality
Ceftaroline
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ceftaroline
Affected / at Risk (%) # Events
Total   1/4 (25.00%)    
Infections and infestations   
Pneumonia  1 [1]  1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
[1]
SAE started at 12:00 pm on and resolved at 13:00 pm on 2014-08-08. It was reported as important medical event which was assessed as moderate and unrelated to study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ceftaroline
Affected / at Risk (%) # Events
Total   3/4 (75.00%)    
Cardiac disorders   
Cardiac failure  1  1/4 (25.00%)  1
Gastrointestinal disorders   
Diarrhoea  1  1/4 (25.00%)  1
Infections and infestations   
Urinary tract  1  1/4 (25.00%)  1
Fungal skin infection  1  1/4 (25.00%)  1
Psychiatric disorders   
Anxiety  1  1/4 (25.00%)  1
Skin and subcutaneous tissue disorders   
Rash generalised  1  1/4 (25.00%)  1
Dermatitis contact  1  1/4 (25.00%)  1
Dermatitis allergic  1  1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Early termination leading to small number of subjects analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The investigator agrees not to use such Confidential study information and not to disclose them to any other third parties, except that the undersigned shall not be prevented from using or disclosing information: (a) which by written records was previously known; (b) which is now public knowledge, (c) which is lawfully obtained by the undersigned from sources who have a lawful right to disclose such information.
Results Point of Contact
Name/Title: Yunxia Lu
Organization: AstraZeneca-PPD
Phone: 910-558-4197
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02202135     History of Changes
Other Study ID Numbers: D3720C00001sub
First Submitted: July 25, 2014
First Posted: July 28, 2014
Results First Submitted: December 18, 2015
Results First Posted: March 31, 2016
Last Update Posted: September 6, 2017