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

Primary Purpose

Prosthetic Joint Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
vancomycin hydrochloride and tobramycin sulfate
Sponsored by
Osteal Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthetic Joint Infection focused on measuring Hip, Knee, Biofilm, Minimum-biofilm-eradication-concentration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Covenant Hospital
  • Ortho Carolina Research Institute
  • SSM Health Bone and Joint Hospital at St. Anthony
  • University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Joint irrigation with vancomycin and tobramycin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2018
Last Updated
December 27, 2021
Sponsor
Osteal Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03721328
Brief Title
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 26, 2018 (Actual)
Primary Completion Date
August 25, 2020 (Actual)
Study Completion Date
August 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Osteal Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Joint Infection
Keywords
Hip, Knee, Biofilm, Minimum-biofilm-eradication-concentration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Joint irrigation with vancomycin and tobramycin
Intervention Type
Combination Product
Intervention Name(s)
vancomycin hydrochloride and tobramycin sulfate
Intervention Description
vancomycin hydrochloride and tobramycin sulfate via local irrigation
Primary Outcome Measure Information:
Title
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Springer, MD
Organizational Affiliation
Ortho Carolina Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covenant Hospital
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Ortho Carolina Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
SSM Health Bone and Joint Hospital at St. Anthony
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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