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NCT Number: NCT02582203

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

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.

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Key information

Conditions

Skin Diseases, Infectious Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Detroit Medical Center, Detroit, Michigan, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ceftaroline

Drug

Vancomycin

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2015
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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