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

Skin Diseases, Infectious Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582203
• Other study ID #: 1111010324
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2015
• Last updated: October 31, 2016
• Start date: February 2012
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Skin Diseases
• Skin Diseases, Infectious
• Staphylococcal Skin Infections

Intervention

Drug:
• Ceftaroline

• Vancomycin

Locations

Country	Name	City	State
United States	Detroit Medical Center	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	St. John Hospital and Medical Center	Detroit	Michigan

Sponsors (5)

Lead Sponsor	Collaborator
Wayne State University	Detroit Medical Center, Forest Laboratories, Henry Ford Hospital, St. John Providence Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	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]	Yes
Primary	Early Clinical Response	Reduction of lesion size from baseline of at least 20%	48 to 72 hours after initiation of study drug	No
Secondary	Overall Clinical Response	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]	No
Secondary	Length of stay	Total duration of hospitalization	During hospitalization [Up to 60 days]	No