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

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

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.

Study Overview

• Status: Completed
• Conditions: Prosthetic Joint Infection
• Intervention / Treatment: Combination product: vancomycin hydrochloride and tobramycin sulfate

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • Covenant Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Ortho Carolina Research Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • SSM Health Bone and Joint Hospital at St. Anthony
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Joint irrigation with vancomycin and tobramycin	Combination product: vancomycin hydrochloride and tobramycin sulfate; vancomycin hydrochloride and tobramycin sulfate via local irrigation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Osteal Therapeutics, Inc.
• Investigators: Principal Investigator: Bryan Springer, MD, Ortho Carolina Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2018
• Primary Completion (Actual): August 25, 2020
• Study Completion (Actual): August 25, 2020

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Knee; Biofilm; Hip; Minimum-biofilm-eradication-concentration
• Additional Relevant MeSH Terms: Infections; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin; Tobramycin
• Other Study ID Numbers: JPS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes