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NGS

NGS + Culture vs Culture Alone for Joint Infections

N/A

Waitlist Available

Research Sponsored by Center for Innovation and Research Organization

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing single stage revision or 1st stage resection arthroplasty/spacer placement for PJI (ICM-positive) of the hip or knee

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year from time to surgery

Awards & highlights

Study Summary

This trial will compare two methods to treat joint infections, one using genetics and one using traditional culture, to see which is more effective.

Who is the study for?

Adults over 18 with a hip or knee joint infection who are having their first surgery to fix it can join. They must be able to give written consent. People already in another trial or those with a very large artificial joint (megaprosthesis) cannot participate.Check my eligibility

What is being tested?

This study is comparing two ways of figuring out the best antibiotic treatment for joint infections: the usual method where bacteria are grown from samples (culture), and a new way using advanced DNA testing (NGS).See study design

What are the potential side effects?

Since this trial compares diagnostic methods, side effects mainly relate to potential inaccuracies in treatment guidance which could lead to ineffective therapy or adverse reactions from unnecessary antibiotics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having surgery for an infection in my hip or knee joint replacement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year from time to surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year from time to surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year from time to surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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

Secondary outcome measures

Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records

Trial Design

2Treatment groups

Active Control

Group I: Culture-based treatmentActive Control1 Intervention

Group II: Next Generation Sequencing (NGS) with Culture-based treatmentActive Control1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Center for Innovation and Research OrganizationLead Sponsor

6 Previous Clinical Trials

1,538 Total Patients Enrolled

Tiffany MorrisonStudy DirectorCenter for Innovation and Research Organization

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any availability for participants in this trial?

"As checked on clinicaltrials.gov, this study is not accepting patients at present - first posted September 21st 2022 and most recently edited October 31st 2023. However, there are currently 778 other trials actively recruiting candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NGS vs Culture Outcomes for Treatment of PJI

2022. "NGS vs Culture Outcomes for Treatment of PJI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05247281.