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

NCT03721328 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: JPS-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

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.

Conditions

Prosthetic Joint Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

Joint irrigation with vancomycin and tobramycin

Combination Product: vancomycin hydrochloride and tobramycin sulfate

Interventions

vancomycin hydrochloride and tobramycin sulfate COMBINATION_PRODUCT

vancomycin hydrochloride and tobramycin sulfate via local irrigation

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osteal Therapeutics, Inc.: lead

Study Sites (4)

Covenant Hospital

Saginaw, Michigan, 48604, United States

Location

Ortho Carolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

SSM Health Bone and Joint Hospital at St. Anthony

Oklahoma City, Oklahoma, 73103, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Interventions

Vancomycin; Tobramycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Nebramycin; Kanamycin; Aminoglycosides; Glycosides

Results Point of Contact

• Title: Nor Consult
• Organization: Nor Consult, LLC

regulatory@nor-consult.com

206-607-6861

Study Officials

• Bryan Springer, MD

  Ortho Carolina Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 26, 2018
• Study Start: October 26, 2018
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: January 11, 2022
• Results First Posted: December 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)