60 Participants Needed

TRL1068 for Prosthetic Joint Infection

Recruiting at 9 trial locations
AL
AK
Overseen ByAdriane Kisch-Hancock
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not be on chronic suppressive antibiotic therapy and should not have received another investigational drug recently. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment TRL1068 for Prosthetic Joint Infection?

The research shows that a similar treatment approach, involving surgical cleaning and antibiotics, successfully eradicated infections in patients with prosthetic joint infections, allowing them to keep their joint implants. This suggests that TRL1068, when used with similar methods, might also be effective in treating these infections.12345

What is the purpose of this trial?

TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making pathogens substantially more susceptible to established antibiotic treatment regimens. This Phase 2 study is designed to assess efficacy and safety of TRL1068 in combination with a DAIR (debridement, antibiotics, and implant retention) procedure for chronic prosthetic joint infections of the knee and hip, specifically, eliminating the need for the standard of care 2-stage exchange surgery, so that the original prosthesis can be retained.

Eligibility Criteria

This trial is for adults aged 18-85 with a first or recurrent chronic prosthetic joint infection in the knee or hip, confirmed by culture. Participants must have stable implants without osteomyelitis and be able to consent and comply with study procedures, including follow-up visits.

Inclusion Criteria

My overall health is rated as good or fair.
I have a first or recurrent infection in my hip or knee confirmed by a fluid test.
I agree to have my prosthesis examined and replaced around 3 months later.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

TRL1068 is administered at 15 mg/kg IV on Day 1 and subsequently at 7.5 mg/kg on Days 15, 29, and 43. A DAIR procedure is completed between Day 15-22.

6 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and efficacy measures.

52 weeks
Regular assessments up to Day 365

Treatment Details

Interventions

  • DAIR
  • TRL1068
Trial Overview TRL1068 (calpurbatug) combined with DAIR procedure is being tested to see if it can clear infections around prosthetic joints without needing to replace the implant. This Phase 2 study aims to make pathogens more vulnerable to antibiotics by removing their protective biofilm.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: TRL1068 + DAIRExperimental Treatment2 Interventions
TRL1068 will be administered at 15 mg/kg IV on Day 1 and subsequently at 7.5 mg/kg on Days 15, 29, and 43. Between Day 15-22, a DAIR procedure will be completed.
Group II: SoCActive Control1 Intervention
Standard of Care arm, receiving 2-stage surgery as is SoC for PJI. Reduced assessments will be done at the same timepoints as the experimental arm.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Trellis Bioscience LLC

Lead Sponsor

Trials
4
Recruited
100+

Findings from Research

In a study of patients with deep total joint infections treated using a prosthesis retaining protocol, all infections were successfully eradicated without the need for further surgery, with a mean follow-up of 37 months.
The treatment involved a combination of surgical debridement, antibiotic-impregnated beads, and intravenous antibiotics, proving effective for early postoperative or acute hematogenous infections in selected patients.
Prosthesis retention, serial debridement, and antibiotic bead use for the treatment of infection following total joint arthroplasty.Tintle, SM., Forsberg, JA., Potter, BK., et al.[2013]
The Combined Diagnostic Tool, which calculates the Combined Tests Index (CTI), effectively predicts the likelihood of joint prosthesis infection, with a significant difference in CTI values between infected (CTI >1) and non-infected patients (CTI <1).
In a study of 36 patients, all 21 with confirmed infections had a CTI above 1, while all 15 without infections had a CTI below 1, demonstrating the tool's potential as a reliable diagnostic indicator.
Combined Diagnostic Tool for joint prosthesis infections.Romano, CL., Romanรฒ, D., Bonora, C., et al.[2019]
In a study of 16 patients with prosthetic joint infections diagnosed through positive intraoperative cultures, a median of 28 days of intravenous antimicrobial therapy led to an impressive 89% survival rate free of treatment failure over 5 years.
The study indicates that infections caused by low virulence pathogens can be effectively managed with shorter courses of intravenous antibiotics, suggesting that less than 6 weeks of treatment may be sufficient for certain cases.
Prosthetic joint infection diagnosed postoperatively by intraoperative culture.Marculescu, CE., Berbari, EF., Hanssen, AD., et al.[2019]

References

Prosthesis retention, serial debridement, and antibiotic bead use for the treatment of infection following total joint arthroplasty. [2013]
Combined Diagnostic Tool for joint prosthesis infections. [2019]
Prosthetic joint infection diagnosed postoperatively by intraoperative culture. [2019]
Long-term suppression of infection in total joint arthroplasty. [2005]
The effect of HIV prevalence, CD4 counts and disease severity on the outcome of total knee arthroplasty for haemophilic arthropathy: a systematic review and meta-analysis. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity