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:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT01196169
Eligibility Criteria:
Inclusion Criteria:
* Signed, and dated informed consent as defined by the Institutional Review Board.
* Male and female patients older than 18 years of age undergoing primary elective hip, knee or shoulder arthroplasty.
* Documented nasal carriage of MRSA.
* If a female of childbearing potential the patient should agree to practice a reliable contraceptive method (e.g. birth control pills, condoms, or intrauterine device \[IUD\]) during treatment and for one month after receiving the study medication.
Exclusion Criteria:
* Concurrent urinary tract infection or colonization unless treated with evidence of microbiologic cure.
* Evidence of active infection elsewhere other than urinary tract, unless treated with evidence of microbiologic cure documented by the infectious diseases service.
* Patients undergoing elective secondary arthroplasty.
* Concurrent open wounds
* Pregnant and nursing women (if patient is still of childbearing potential, a negative serum pregnancy test will be confirmed).
* History of allergy or contraindication to study drugs.
* Weight \>150 kg or \<50kg
* Patients with creatinine clearance (CLcr) \< 30ml/min (calculated using the Cockcroft-Gault equation using ideal body weight)
* Severe neutropenia (absolute neutrophil count \<0.500x103 /µl).
* Patients considered unlikely to comply with study procedures or to return for the scheduled post treatment evaluation.
* Ongoing antibiotic therapy for active infection that is anticipated to continue until the day of surgery.
* Any other condition that in the opinion of the investigator, would confound or interfere with evaluation of safety or efficacy of the investigational medication, or prevent compliance with the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01196169
Study Brief:
Protocol Section:
NCT01196169