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Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA

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: NCT02582203
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : November 1, 2016
Sponsor:
Collaborators:
Henry Ford Hospital
St. John Providence Health System
Detroit Medical Center
Forest Laboratories
Information provided by (Responsible Party):
Michael J. Rybak, Wayne State University

Brief Summary:
The proposed study is a prospective, open-label, randomized, multi-center trial of ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. John Medical Center in Detroit Michigan with a documented ABSSSI between April 2012 and November 2015 will be evaluated for inclusion. Patients must present with at least 3 of the following local signs/symptoms: pain, tenderness, swelling erythema, warmth, drainage/discharge, induration, and lymph node swelling/tenderness. Patients will be randomized 1:1 ceftaroline or vancomycin with optional anaerobic and/or Gram-negative coverage. The assignment of study drug will follow a randomized list that was previously generated via a computerized random mix block generator (nQuery Advisor® 7.0) and available at each of the study sites. Patients will be randomized to ceftaroline intravenously at 600 mg infused over 1 hour every 12 hours for patients with normal renal function. Patients randomized to vancomycin will receive the standard 15 mg/kg dose based on total body weight infused over 1 hour q 12 hour, dose and interval adjusted based on creatinine clearance and via institution-specific pharmacy protocol to target serum trough concentrations of 10-20 mg/L within the first 72 hours. Outcomes measured in the Clinically Evaluable patient population include day two or three size reduction (percentage) and clinical response at end of therapy or discharge.

Condition or disease Intervention/treatment Phase
Skin Diseases, Infectious Staphylococcal Skin Infections Drug: Ceftaroline Drug: Vancomycin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Economic Outcomes of Ceftaroline Fosamil for the Treatment of Acute Bacterial Skin and Skin Structure Infections Documented or at Risk of Methicillin-Resistant S. Aureus
Study Start Date : February 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ceftaroline
600 mg IV (over 1 hour) every 12 hours for renal function > 50 mL/min, adjusted for renal function based on package insert for no more than 14 days.
Drug: Ceftaroline
Active Comparator: Vancomycin
Dosed by institutional pharmacy protocol to reach goal trough level of 10 - 20 mg/L steady state concentration for no more than 14 days.
Drug: Vancomycin



Primary Outcome Measures :
  1. Early Clinical Response [ Time Frame: 48 to 72 hours after initiation of study drug ]
    Reduction of lesion size from baseline of at least 20%


Secondary Outcome Measures :
  1. Overall Clinical Response [ Time Frame: End or therapy or patient discharge [Up to 60 days] ]

    Cure: pretreatment signs and symptoms are improved or resolved and no additional antibiotic therapy is necessary

    • Improved: pretreatment signs and symptoms are improved and additional antibiotic therapy is necessary
    • Failure: Persistent, worsening, or new/recurrent signs and symptoms, antibiotics needed > 14 days, or the need for a change in antibiotic therapy

  2. Length of stay [ Time Frame: During hospitalization [Up to 60 days] ]
    Total duration of hospitalization


Other Outcome Measures:
  1. Adverse Events [ Time Frame: During treatment with study drug [Up to 60 days] ]
    Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Acute bacterial skin and skin structure infection (cellulitis, major abscess, surgical site infection)
  • Presence of MRSA or documented risk factors for MRSA (prior antibiotic use 60 days, prior hospital exposure 180 days, skin ulcers, central venous catheter)
  • Anticipating no less than two days of hospital admission
  • Signed informed consent

Exclusion Criteria:

  • Gas gangrene/progressive necrotizing infections
  • Osteomyelitis
  • Infections due to Gram-negative pathogens or other Gram-positive pathogens if S. aureus or Streptococcus is not present
  • Pathogens known at the study entry to be resistant to ceftaroline or vancomycin
  • Anticipated to require non-study antibiotic active against S. aureus for another reason
  • Treatment for the current episode of ABSSSI for > 24 hours with another intravenous anti-MRSA antibiotic
  • Surgical (I & D) as definitive/curative treatment
  • Presence of prosthetic hardware or invasive devices suspected to be the source of infection but cannot be removed
  • Life expectancy < 2 months
  • Open burn wound > 30% total body surface area
  • Pregnant or nursing mothers
  • Known allergic reaction to vancomycin or ceftaroline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582203


Locations
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United States, Michigan
Detroit Medical Center
Detroit, Michigan, United States, 48201
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Wayne State University
Henry Ford Hospital
St. John Providence Health System
Detroit Medical Center
Forest Laboratories
Investigators
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Principal Investigator: Michael Rybak, PharmD, MPH Wayne State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael J. Rybak, Director, Anti-Infective Research Laboratory, Wayne State University
ClinicalTrials.gov Identifier: NCT02582203    
Other Study ID Numbers: 1111010324
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Keywords provided by Michael J. Rybak, Wayne State University:
Ceftaroline fosamil
Vancomycin
Acute bacterial skin and skin structure infections
Methicillin-resistant S. aureus
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cellulitis
Skin Diseases, Infectious
Staphylococcal Skin Infections
Skin Diseases
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Vancomycin
Ceftaroline fosamil
Anti-Bacterial Agents
Anti-Infective Agents