Abbreviated Protocol for Two-Stage Exchange (NCT04662632) | Clinical Trial Compass
CompletedPhase 2
Abbreviated Protocol for Two-Stage Exchange
United States76 participantsStarted 2021-11-01
Plain-language summary
Study Type: A multi-site, parallel group, randomized trial.
Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days). Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of periprosthetic joint infection (PJI). Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints.
Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.
Who can participate
Age range22 Years – 84 Years
SexALL
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Inclusion Criteria:
* Scheduled for two-stage exchange arthroplasty due to hip or knee PJI
* Signed informed consent
* 22 to 84 years of age (inclusive)
* Medical clearance for surgery
* Preoperative diagnosis of PJI of the hip or knee per the International Consensus Meeting of Musculoskeletal Infection 2018 definition of Periprosthetic Hip and Knee Infection
Exclusion Criteria:
* Patients with 2 or more prior one-stage or two-stage exchange arthroplasties of the infected joint;
* Patients with acute PJI, defined as total joint arthroplasty surgery within 4 weeks prior to enrollment (Stage 1) in this study;
* Patients with bacteremia or positive bacterial blood culture in the last 30 days;
* Patients with concurrent PJI of more than one joint;
* Patients with ongoing active infection of an intravenous site;
* Patients who require long-term anticoagulation or antiplatelet therapy, and for whom bridging or withholding therapy is not recommended based on the individual's clinical condition;
* Patients with advanced renal insufficiency (chronic kidney disease Stage 4 or greater or glomerular filtration rate \<30 mL/min);
* Patients on chemotherapy for malignant disease;
* Patients on systemic glucocorticoid therapy (prednisone \>10 mg/day or equivalent);
* Patients with immunodeficiency (e.g., splenectomy, sickle cell anemia, Stage 3 human immunodeficiency virus infection, primary immunodeficiency disease, except immunodeficiency due to immunosuppressive therapy).
* Patients w…