Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
NCT ID:
NCT02307006
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02307006
Study Brief:
Protocol Section:
NCT02307006