NGS vs Culture Outcomes for Treatment of PJI

NCT ID: NCT05247281

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-21

Study Completion Date

2025-05-31

Brief Summary

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

Detailed Description

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Conditions

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Prosthetic Joint Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Culture-based treatment

Group Type ACTIVE_COMPARATOR

Culture-based treatment

Intervention Type DIAGNOSTIC_TEST

Medications to treat prosthetic joint infection will be chosen based on results of traditional cultures alone

Next Generation Sequencing (NGS) with Culture-based treatment

Group Type ACTIVE_COMPARATOR

Next Generation Sequencing (NGS) with Culture

Intervention Type DIAGNOSTIC_TEST

Medications to treat prosthetic joint infection will be chosen based results of NGS and culture

Interventions

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Culture-based treatment

Medications to treat prosthetic joint infection will be chosen based on results of traditional cultures alone

Intervention Type DIAGNOSTIC_TEST

Next Generation Sequencing (NGS) with Culture

Medications to treat prosthetic joint infection will be chosen based results of NGS and culture

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center for Innovation and Research Organization

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tiffany Morrison

Role: STUDY_DIRECTOR

Center for Innovation and Research Organization

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Columbia University

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Northwell Health

Staten Island, New York, United States

Site Status

Cleveland Clinic Ohio

Cleveland, Ohio, United States

Site Status

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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2022NGSOutcomes

Identifier Type: -

Identifier Source: org_study_id

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