NGS + Culture vs Culture Alone for Joint Infections

Not currently 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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding Next Generation Sequencing (NGS) to traditional methods can improve treatment for joint infections, particularly in individuals with hip or knee issues after surgery. NGS is a modern technique that identifies bacteria by analyzing their DNA, potentially helping doctors select more effective antibiotics. Suitable participants are adults who have undergone surgery for an infected hip or knee joint and are not enrolled in another trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options for joint infections.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for treating joint infections?

Research has shown that Next Generation Sequencing (NGS) accurately diagnoses infections, including those in joints. This method proves especially useful when traditional tests fail to detect infections. Studies have demonstrated that NGS effectively identifies the germs causing these infections, leading to better treatment options.

In terms of safety, NGS examines the DNA of bacteria in a lab setting to identify them. No reports indicate it causes harm to patients, as it tests samples outside the body. Overall, NGS is considered a promising tool for improving infection treatment without adding risks to patients.12345

Why are researchers excited about this trial?

Researchers are excited about using Next Generation Sequencing (NGS) with culture for joint infections because it offers a more comprehensive approach to identifying pathogens. Unlike the traditional culture methods that may miss certain bacteria, NGS can detect a wider variety of microorganisms, including those that are hard to grow in a lab. This could lead to more accurate diagnoses and targeted treatments, potentially improving patient outcomes and reducing the time needed to find effective therapies.

What evidence suggests that this trial's treatments could be effective for joint infections?

Research shows that using Next Generation Sequencing (NGS) alongside traditional methods effectively diagnoses infections around joint replacements. In this trial, one group of participants will receive Next Generation Sequencing (NGS) with Culture-based treatment. Studies have found that this combination can accurately identify bacteria, even when traditional methods fail, particularly in cases where standard tests detect no bacteria. NGS can uncover infections that other methods might miss and helps identify bacteria that are difficult to grow in a lab, leading to faster diagnosis. In one study, NGS showed positive results in 59 cases, compared to only 36 with traditional methods alone. These findings suggest that combining NGS with traditional methods could effectively guide treatment for joint infections. Meanwhile, another group in this trial will receive Culture-based treatment alone.56789

Who Is on the Research Team?

TM

Tiffany Morrison

Principal Investigator

Center for Innovation and Research Organization

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).
How Is the Trial Designed?
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+

Citations

Multiplex PCR in septic arthritis and periprosthetic joint ...This study evaluates the outcome of the application of a new, score‐based SA and PJI diagnostic algorithm, which includes the execution of molecular testing on ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/35755833/
A Systematic Review and Meta-AnalysisConclusion: Metagenomic next-generation sequencing displays high accuracy in the diagnosis of PJI, especially for culture-negative cases.
Metagenomic next-generation sequencing in osteoarticular ...Potential benefits include pathogen identification unaffected by antimicrobial administration, detection of fastidious organisms more quickly, ...
The contribution of metagenomic next-generation ...In this report, we present a case of pyogenic hip arthritis with gas gangrene caused by Fusobacterium, where mNGS was utilized for diagnosis.
Direct detection and identification of periprosthetic joint ...A total of 36 cases had positive culture results and 59 cases had positive metagenomic next-generation sequencing results. Culture was positive ...
Metagenomic Next-Generation Sequencing for Periprosthetic ...The purpose of this study was to highlight the impact of periprosthetic joint infections in the healthcare system and the need to focus on the ...
Next generation sequencing for pathogen detection in ...Periprosthetic joint infections (PJI) represent one of the most catastrophic complications following total joint arthroplasty (TJA).
The Role of Next-Generation Sequencing (NGS) in ...Our study is an up-to-date review of the hot topic application of NGS in the study and investigation of periprosthetic infections and the microbiome.
The Effectiveness of Metagenomic Next-Generation ...Conclusion: Metagenomic next-generation sequencing displays high accuracy in the diagnosis of PJI, especially for culture-negative cases.
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