NGS vs Culture Outcomes for Treatment of PJI

Prosthetic Joint Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05247281
• Other study ID #: 2022NGSOutcomes
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: Center for Innovation and Research Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Prosthetic Joint Infection

Intervention

Diagnostic Test:
• Culture-based treatment
Medications to treat prosthetic joint infection will be chosen based on results of traditional cultures alone
• Next Generation Sequencing (NGS) with Culture
Medications to treat prosthetic joint infection will be chosen based results of NGS and culture

Locations

Country	Name	City	State
United States	Cleveland Clinic Ohio	Cleveland	Ohio
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Southern California	Los Angeles	California
United States	Columbia University	New York	New York
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	University of Utah	Salt Lake City	Utah
United States	Northwell Health	Staten Island	New York
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Center for Innovation and Research Organization

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 days from time of surgery
Secondary	Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records		one year from time to surgery