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

• ClinicalTrials.gov Identifier: NCT03721328
• Recruitment Status: Completed
• First Posted: October 26, 2018
• Results First Posted: December 9, 2021
• Last Update Posted: January 11, 2022
• Sponsor: Osteal Therapeutics, Inc.
• Information provided by (Responsible Party): Osteal Therapeutics, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Prosthetic Joint Infection	Combination Product: vancomycin hydrochloride and tobramycin sulfate	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 26, 2018
• Actual Primary Completion Date: August 25, 2020
• Actual Study Completion Date: August 25, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Safety Evaluations: Number and Frequency of Adverse Events Among Participants [ Time Frame: 12 months ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Michigan

Covenant Hospital

Saginaw, Michigan, United States, 48604

United States, North Carolina

Ortho Carolina Research Institute

Charlotte, North Carolina, United States, 28207

United States, Oklahoma

SSM Health Bone and Joint Hospital at St. Anthony

Oklahoma City, Oklahoma, United States, 73103

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15261

Sponsors and Collaborators

Osteal Therapeutics, Inc.

Investigators

• Principal Investigator: Bryan Springer, MD; Ortho Carolina Research Institute

  Study Documents (Full-Text)

Documents provided by Osteal Therapeutics, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] June 28, 2019

More Information

• Responsible Party: Osteal Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03721328
• Other Study ID Numbers: JPS-001
• First Posted: October 26, 2018
• Results First Posted: December 9, 2021
• Last Update Posted: January 11, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Osteal Therapeutics, Inc.:

Hip; Knee; Biofilm; Minimum-biofilm-eradication-concentration

Additional relevant MeSH terms:

Infections; Vancomycin; Tobramycin; Anti-Bacterial Agents; Anti-Infective Agents