Recruiting

Ceftaroline

Sponsor:

University of Cincinnati

Code:

NCT02307006

Conditions

Surgical Site Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ceftaroline

Cefazolin / Vancomycin

Study Details

Brief summary:

The study is a randomized double-blinded study comparing ceftaroline to standard of care therapy with cefazolin and vancomycin as surgical prophylaxis for high risk orthopedic and cardiac surgeries. Study participants will be enrolled from those undergoing cardiothoracic surgery involving sternotomy and those undergoing prosthetic joint replacement of either hip or knee. Consenting patients will be randomized 2:1 to receive either ceftaroline or cefazolin/vancomycin. This study will be blinded by the use of placebo vancomycin infusions and placebo cephalosporin infusions. The primary end point will be the development of a surgical site infection within 30 days of surgery.

Conditions

Surgical Site Infection

Study ID

NCT02307006

Start date

Jan, 2015

Status verified date

Nov, 2015

Completion date

Jun, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Informed Consent
  • Age - 18 years and older
  • Patients undergoing either hip or knee arthroplasty or cardiac surgery with sternotomy
  • Body mass index (BMI) between 18 and 30 kg/m2 inclusive.
  • Female subjects must have a negative serum pregnancy test and be using appropriate contraception.

Exclusion Criteria:

  • Pregnancy
  • Hypersensitivity or allergic reaction to any β-lactam antibiotic or vancomycin.
  • Presence of cardiovascular shock,
  • Receipt of chronic concomitant systemic corticosteroids, 40 mg of prednisone equivalent;
  • Severe renal impairment (i.e. Creatinine clearance ≤ 30 mL/min);
  • Significant hepatic impairment (i.e. known acute viral hepatitis, aspartate aminotransferase or alanine aminotransferase concentration 10-fold the upper limit of normal (ULN) or total bilirubin 3-fold the ULN or manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy),
  • Hematological impairment with current or anticipated neutropenia with less than 500 neutrophils/mm3 or thrombocytopenia with platelet count of 60 000 cells/mm3
  • HIV infection which at the time of screening meets 2008 CDC criteria for AIDS.
  • Patients undergoing revision surgery for infected prosthetic joint replacement.
  • Body mass index (BMI) less than 18 or greater than 30 kg/m2.
  • Concurrent antibiotics

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Ceftaroline

Experimental comparator for surgical peri-operative prophylaxis for procedures at increased risk if MRSA infection

active comparator: Cefazolin / Vancomycin

Standard of care comparator for surgical peri-operative prophylaxis for procedures at increased risk if MRSA infection

Interventions

Ceftaroline

Surgical prophylaxis

Cefazolin / Vancomycin

Standard of care surgical prophylaxis

Primary outcome measure

  • Surgical site infection [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Alan G Smulian, M.B.B. Ch.

513 558-4248smuliang@fuse.net

Locations

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

West Chester Hospital

Recruiting

West Chester, Ohio, United States, 45069

More Information

Sponsor

University of Cincinnati

Last update posted

Dec 2, 2015

Last verified

Nov, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2015-12-02.