NCT02582203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

4.2 years

First QC Date

October 16, 2015

Last Update Submit

October 31, 2016

Conditions

Skin Diseases, InfectiousStaphylococcal Skin Infections

Keywords

Ceftaroline fosamilVancomycinAcute bacterial skin and skin structure infectionsMethicillin-resistant S. aureus

Outcome Measures

Primary Outcomes (1)

  • Early Clinical Response

    Reduction of lesion size from baseline of at least 20%

    48 to 72 hours after initiation of study drug

Secondary Outcomes (2)

  • Overall Clinical Response

    End or therapy or patient discharge [Up to 60 days]

  • Length of stay

    During hospitalization [Up to 60 days]

Other Outcomes (1)

  • Adverse Events

    During treatment with study drug [Up to 60 days]

Study Arms (2)

Ceftaroline

ACTIVE COMPARATOR

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

Vancomycin

ACTIVE COMPARATOR

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

Interventions

CeftarolineDRUG
Ceftaroline
VancomycinDRUG
Vancomycin

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • Claeys KC, Zasowski EJ, Trinh TD, Casapao AM, Pogue JM, Bhatia N, Mynatt RP, Wilson SS, Arthur C, Welch R, Sherwin R, Hafeez W, Levine DP, Kaye KS, Delgado G, Giuliano CA, Takla R, Rieck C, Johnson LB, Murray KP, Gordon J, Reyes K, Hartman P, Davis SL, Rybak MJ. Open-Label Randomized Trial of Early Clinical Outcomes of Ceftaroline Fosamil Versus Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections at Risk of Methicillin-Resistant Staphylococcus aureus. Infect Dis Ther. 2019 Jun;8(2):199-208. doi: 10.1007/s40121-019-0242-5. Epub 2019 Mar 27.

    PMID: 30915685DERIVED

MeSH Terms

Conditions

Skin Diseases, InfectiousStaphylococcal Skin Infections

Interventions

CeftarolineVancomycin

Condition Hierarchy (Ancestors)

InfectionsSkin DiseasesSkin and Connective Tissue DiseasesStaphylococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSkin Diseases, Bacterial

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Michael Rybak, PharmD, MPH

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Anti-Infective Research Laboratory

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 21, 2015

Study Start

February 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

US(3)