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

October 31, 2016 updated by: Michael J. Rybak, Wayne State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Detroit Medical Center
      • Detroit, Michigan, United States, 48201
        • St. John Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Clinical Response
Time Frame: 48 to 72 hours after initiation of study drug
Reduction of lesion size from baseline of at least 20%
48 to 72 hours after initiation of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End or therapy or patient discharge [Up to 60 days]
Length of stay
Time Frame: During hospitalization [Up to 60 days]
Total duration of hospitalization
During hospitalization [Up to 60 days]

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During treatment with study drug [Up to 60 days]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

Forest Laboratories
Henry Ford Hospital
St. John Providence Health System
Detroit Medical Center

Investigators

  • Principal Investigator: Michael Rybak, PharmD, MPH, Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (ESTIMATE)

October 21, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1111010324

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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