Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation

Study Overview
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Brief Summary
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Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI. Primary Outcome Measure The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions. Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.

Official Title
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A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Patients Treated for Hip or Knee Prosthetic Joint Infection (PJI) With Alternating Irrigation of Vancomycin Hydrochloride (HCl) and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty

Conditions
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Prosthetic Joint Infection

Intervention / Treatment
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* Combination Product: vancomycin hydrochloride and tobramycin sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years or greater Preoperative diagnosis of PJI of the hip or knee per the 2018 Definition of Periprosthetic Hip and Knee Infection Chronic PJI (symptoms lasting at least 4 weeks) per Tsukayama et al. Medical clearance for surgery Physical and mental ability and willingness to comply with the protocol, including the ability to read and complete required forms, and willingness and ability to adhere to the scheduled follow-up visits and requirements of the protocol Exclusion Criteria: Late acute hematogenous infection per Tsukayama et al. Patients for whom a two-stage exchange arthroplasty is not indicated Sepsis Previously failed single- or two-stage revision arthroplasty for PJI (aseptic revision, polyethylene liner exchange, and/or irrigation and debridement with component retention is allowed) Patients with PJI of more than one joint Patients on chronic antibiotic therapy (≥ 6 months duration) Patients who require therapeutic anticoagulation Patients on antiplatelet therapy for whom withholding antiplatelet therapy for any amount of time is contraindicated Patients with renal insufficiency/failure (serum creatinine ≥ 2.0 mg/dl) Patients with uncontrolled diabetes, defined as: hemoglobin A1C levels > 8.0% Patients on immunosuppressive therapy, chemotherapy for malignant disease, or glucocorticoid therapy (e.g. prednisone ≥ 10 mg/day). Patients with immunodeficiency (e.g., splenectomy; sickle cell anemia; Stage 3 HIV; primary humoral, bone marrow, or other transplantation.) Anticipated or potential patient relocation that may interfere with follow-up examinations Allergy to vancomycin HCl or tobramycin sulfate (Note: prior history of Red Man's syndrome is not considered an allergy) Patients who are pregnant or planning to become pregnant Patients in whom negative pressure wound therapy is contraindicated Patients infected with pathogens that are not considered susceptible to vancomycin HCl or tobramycin sulfate, as per the Investigator's opinion Breastfeeding at screening visit Patients who are prisoners Participation in another clinical trial of another Investigational Drug or Investigational Device within the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Joint irrigation with vancomycin and tobramycin | Combination Product: vancomycin hydrochloride and tobramycin sulfate<br>* vancomycin hydrochloride and tobramycin sulfate via local irrigation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evaluations: Number and Frequency of Adverse Events Among Participants | The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Knee, Biofilm, Minimum-biofilm-eradication-concentration