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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03721328
Recruitment Status : Active, not recruiting
First Posted : October 26, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Joint Purification Systems

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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 With Alternating Irrigation of Vancomycin HCl and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty
Actual Study Start Date : October 26, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020


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




Primary Outcome Measures :
  1. Safety Evaluations [ 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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721328


Locations
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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
Joint Purification Systems
Investigators
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Principal Investigator: Bryan Springer, MD Ortho Carolina Research Institute

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Responsible Party: Joint Purification Systems
ClinicalTrials.gov Identifier: NCT03721328     History of Changes
Other Study ID Numbers: JPS-001
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Joint Purification Systems:
Hip
Knee
Biofilm
Minimum-biofilm-eradication-concentration
Additional relevant MeSH terms:
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Infection
Vancomycin
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents