Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/6/2019 |
| Start Date: | October 26, 2018 |
| End Date: | June 2020 |
| Contact: | Kimberly Martin, PhD |
| Email: | kim.martin@boulderclinicalscience.com |
| Phone: | 303.261.7891 |
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
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 primary outcome measure is the number of successful subjects. A successful subject is
defined as a subject who achieves ALL of the following qualitative criteria in a composite
endpoint.
To be considered a success, patients must achieve ALL of the following components of the
composite endpoint after 6 weeks of antibiotic treatment and a 2-week antibiotic holiday:
- Have a permanent revision prosthesis implanted by 12 weeks post initial surgery; Yes or
No AND
- Have the same functioning prosthesis at 12 weeks post initial surgery; Yes or No AND
- Show no signs of infection, per the Delphi Criteria, between implantation and 12 weeks
post initial surgery Yes or No AND
- Have no surgical intervention for infection between initial surgery and 12 weeks post
initial surgery. Yes or No
Delphi Criteria: (1) infection eradication, characterized by a healed wound without fistula,
drainage, or pain, and no infection recurrence caused by the same organism strain; (2) no
subsequent surgical intervention after reimplantation surgery owing to infection; and (3) no
occurrence of PJI-related mortality (by causes such as sepsis, necrotizing fasciitis.
Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 1
year from initial surgery.
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 primary outcome measure is the number of successful subjects. A successful subject is
defined as a subject who achieves ALL of the following qualitative criteria in a composite
endpoint.
To be considered a success, patients must achieve ALL of the following components of the
composite endpoint after 6 weeks of antibiotic treatment and a 2-week antibiotic holiday:
- Have a permanent revision prosthesis implanted by 12 weeks post initial surgery; Yes or
No AND
- Have the same functioning prosthesis at 12 weeks post initial surgery; Yes or No AND
- Show no signs of infection, per the Delphi Criteria, between implantation and 12 weeks
post initial surgery Yes or No AND
- Have no surgical intervention for infection between initial surgery and 12 weeks post
initial surgery. Yes or No
Delphi Criteria: (1) infection eradication, characterized by a healed wound without fistula,
drainage, or pain, and no infection recurrence caused by the same organism strain; (2) no
subsequent surgical intervention after reimplantation surgery owing to infection; and (3) no
occurrence of PJI-related mortality (by causes such as sepsis, necrotizing fasciitis.
Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 1
year from initial surgery.
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:
- Acute PJI, defined as ≤ 28 days after the index operation
- Late acute hematogenous infection per Tsukayama et al.
- Patients for whom a two-stage exchange arthroplasty is not indicated
- Systemic 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 (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
We found this trial at
5
sites
Charlotte, North Carolina 28207
Principal Investigator: Bryan Springer, MD
Phone: 704-323-2263
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Kenneth Urish, MD
Phone: 412-864-3654
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Indianapolis, Indiana 46278
Principal Investigator: Edward Helman, MD
Phone: 317-802-2851
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Saginaw, Michigan 48604
Principal Investigator: Brian de Beaubian, MD
Phone: 989-583-5173
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