Back to resultsNGS vs Culture Outcomes for Treatment of PJI
Primary Purpose
Prosthetic Joint Infection
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Culture-based treatment
Next Generation Sequencing (NGS) with Culture
Sponsored by
About this trial
This is an interventional diagnostic trial for Prosthetic Joint Infection
Eligibility Criteria
Inclusion Criteria:
- Adults (age > 18 years)
- Undergoing single stage revision or 1st stage resection arthroplasty/spacer placement for PJI (ICM-positive) of the hip or knee
- Written informed consent
Exclusion Criteria:
- Ongoing participation in another clinical trial
- Megaprosthesis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Culture-based treatment
Next Generation Sequencing (NGS) with Culture-based treatment
Arm Description
Outcomes
Primary Outcome Measures
Number of participants who have been diagnosed with prosthetic joint infection as assessed by the 2018 International Consensus Definition of prosthetic joint infection
Diagnosis of re-infection following surgery and treatment for prosthetic joint infection
Secondary Outcome Measures
Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records
Full Information
NCT ID
NCT05247281
First Posted
January 13, 2022
Last Updated
May 18, 2022
Sponsor
Center for Innovation and Research Organization
1. Study Identification
Unique Protocol Identification Number
NCT05247281
Brief Title
NGS vs Culture Outcomes for Treatment of PJI
Official Title
Randomized Controlled Trial Investigating the Use of Next-generation Sequencing in Directing the Antimicrobial Treatment of Periprosthetic Joint Infection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Innovation and Research Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Joint Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Culture-based treatment
Arm Type
Active Comparator
Arm Title
Next Generation Sequencing (NGS) with Culture-based treatment
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Culture-based treatment
Intervention Description
Medications to treat prosthetic joint infection will be chosen based on results of traditional cultures alone
Intervention Type
Diagnostic Test
Intervention Name(s)
Next Generation Sequencing (NGS) with Culture
Intervention Description
Medications to treat prosthetic joint infection will be chosen based results of NGS and culture
Primary Outcome Measure Information:
Title
Number of participants who have been diagnosed with prosthetic joint infection as assessed by the 2018 International Consensus Definition of prosthetic joint infection
Description
Diagnosis of re-infection following surgery and treatment for prosthetic joint infection
Time Frame
90 days from time of surgery
Secondary Outcome Measure Information:
Title
Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records
Time Frame
one year from time to surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (age > 18 years)
Undergoing single stage revision or 1st stage resection arthroplasty/spacer placement for PJI (ICM-positive) of the hip or knee
Written informed consent
Exclusion Criteria:
Ongoing participation in another clinical trial
Megaprosthesis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VP, Research and Development, MS
Phone
7178561202
Email
tiffany@parvizisurgical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Morrison
Organizational Affiliation
Center for Innovation and Research Organization
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
NGS vs Culture Outcomes for Treatment of PJI
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