NGS vs Culture Outcomes for Treatment of PJI

November 6, 2023 updated by: Center for Innovation and Research Organization

Randomized Controlled Trial Investigating the Use of Next-generation Sequencing in Directing the Antimicrobial Treatment of Periprosthetic Joint Infection

This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • Rochester, New York, United States, 14618
        • University of Rochester
      • Staten Island, New York, United States, 10309
        • Northwell Health
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Ohio
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University Of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Culture-based treatment
Diagnostic test: Culture-based treatment
Medications to treat prosthetic joint infection will be chosen based on results of traditional cultures alone
Active Comparator: Next Generation Sequencing (NGS) with Culture-based treatment
Diagnostic test: Next Generation Sequencing (NGS) with Culture
Medications to treat prosthetic joint infection will be chosen based results of NGS and culture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who have been diagnosed with prosthetic joint infection as assessed by the 2018 International Consensus Definition of prosthetic joint infection
Time Frame: 90 days from time of surgery
Diagnosis of re-infection following surgery and treatment for prosthetic joint infection
90 days from time of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records
Time Frame: one year from time to surgery
one year from time to surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Innovation and Research Organization

Investigators

  • Study Director: Tiffany Morrison, Center for Innovation and Research Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022NGSOutcomes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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