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The Use of Ceftaroline as Surgical Prophylaxis in Surgery With Risk of MRSA Infection (PREVTAROLINE)

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ClinicalTrials.gov Identifier: NCT02307006
Recruitment Status : Unknown
Verified November 2015 by George Smulian, University of Cincinnati.
Recruitment status was:  Recruiting
First Posted : December 3, 2014
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
George Smulian, University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Ceftaroline Drug: Cefazolin / Vancomycin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: IDC 56: 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 Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: Ceftaroline
Experimental comparator for surgical peri-operative prophylaxis for procedures at increased risk if MRSA infection
Drug: Ceftaroline
Surgical prophylaxis
Other Name: Teflaro

Active Comparator: Cefazolin / Vancomycin
Standard of care comparator for surgical peri-operative prophylaxis for procedures at increased risk if MRSA infection
Drug: Cefazolin / Vancomycin
Standard of care surgical prophylaxis
Other Names:
  • Ancef
  • Vancin




Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: 30 days ]
    Surgical site infection rates at either the primary surgical site or any remote surgical site


Secondary Outcome Measures :
  1. Other infection [ Time Frame: 30 days ]
    Other infections, viz. pulmonary, UTI, line related

  2. Drug intolerance [ Time Frame: 30 days ]
    Drug related, viz., rash, itching, nausea, vomiting

  3. Repeat surgery [ Time Frame: 30 days ]
    Return to OR



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307006


Contacts
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Contact: Alan G Smulian, M.B.B. Ch. 513 558-4248 smuliang@fuse.net

Locations
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United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
West Chester Hospital Recruiting
West Chester, Ohio, United States, 45069
Sponsors and Collaborators
University of Cincinnati
Forest Laboratories
Investigators
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Principal Investigator: Alan G Smulian, M.B.B.Ch. University of Cincinnati

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Responsible Party: George Smulian, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02307006     History of Changes
Other Study ID Numbers: IDC 56 / IIT-USA-000585/
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Infection
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Vancomycin
Cefazolin
Ceftaroline fosamil
Anti-Bacterial Agents
Anti-Infective Agents