Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection
Public ClinicalTrials.gov record NCT06621251. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2 Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Chronic Prosthetic Joint Infection of the Knee or Hip Without Exchange Arthroplasty
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06621251
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Interventions
- TRL1068 (calpurbatug), a human monoclonal antibody Drug
- DAIR Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 7, 2025
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2027
- Last update posted
- May 6, 2026
2025 – 2027
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| OrthoArizona | Gilbert | Arizona | 85234 | — |
| UCLA | Los Angeles | California | 90024 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| Gulfcoast Research Institute | Sarasota | Florida | 34232 | — |
| Phoenix Clinical Research | Tamarac | Florida | 33321 | — |
| Sinai Hospital Baltimore | Baltimore | Maryland | 21215 | — |
| New England Baptist Hospital | Boston | Massachusetts | 02120 | — |
| University of Rochester | Rochester | New York | 14623 | — |
| M3 Wake Research Associates | Wilmington | North Carolina | 28412 | — |
| North Texas Medical Research Institute | Rockwall | Texas | 75087 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06621251, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 6, 2026 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06621251 live on ClinicalTrials.gov.