NGS + Culture vs Culture Alone for Joint Infections
Recruiting at 8 trial locations
VR
Overseen ByVP, Research and Development, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Center for Innovation and Research Organization
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.
Research Team
TM
Tiffany Morrison
Principal Investigator
Center for Innovation and Research Organization
Eligibility Criteria
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.Inclusion Criteria
I am having surgery for an infection in my hip or knee joint replacement.
I am over 18 years old.
Written informed consent
Exclusion Criteria
Ongoing participation in another clinical trial
Megaprosthesis
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive antimicrobial treatment directed by either NGS or traditional culture methods
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Treatment Details
Interventions
- Culture-based treatment
- Next Generation Sequencing (NGS) with Culture
Trial Overview 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).
Participant Groups
2Treatment groups
Active Control
Group I: Culture-based treatmentActive Control1 Intervention
Group II: Next Generation Sequencing (NGS) with Culture-based treatmentActive Control1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Center for Innovation and Research Organization
Lead Sponsor
Trials
7
Recruited
1,800+
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