RECRUITING

Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection

Conditions

Prosthetic Joint Infections of Hip Prosthetic Joint Infections of Knee biofilm antibiotic-resistant infections

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-03-12

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06621251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 to 85 years, inclusive 2. Chronic PJI: 1. Systemic Host Grade of A or B \[McPherson 2011\] (Appendix 3) and either 2. First chronic PJI of the hip or knee, confirmed by synovial fluid aspirate culture or 3. Recurrent chronic PJI of the hip or knee confirmed by synovial fluid aspirate culture 3. Willing to be randomized to either: 1. Receive TRL1068 and to be scheduled for DAIR between Day 15 + 7 days (i.e., between days 15-22) and 10 weeks of targeted antibiotic treatment or 2. Participate in an observational study arm that receives SoC (i.e., two-stage prosthetic joint replacement) and 4. At least 1 positive bacterial culture without concomitant fungal infection from the infected joint (a joint aspirate within 28 days prior to Screening is acceptable) 5. All identified pathogen(s) are susceptible to the planned antibiotic regimen 6. Availability of radiology assessments of the affected joint without signs of loosening of the prosthesis or presence of osteomyelitis 7. Willing and able to provide written informed consent 8. Willing to perform and comply with all study procedures, including attending clinic visits as scheduled 9. Men and women of childbearing potential (WOCBP) must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine device (IUD), or use of spermicide combined with a barrier method (e.g., condom, diaphragm) through Day 365.	1. PJI associated with presence of concomitant fungal infection or bacterial pathogens that, even when in planktonic form (i.e., when released from biofilm), cannot be adequately treated with available antibiotics. 2. More than one draining sinus and single draining sinus of \> 1 cm 3. Less than 3 years life expectancy based on underlying morbidities 4. Expected to receive chronic suppressive antibiotic therapy 5. Congestive heart failure; New York Heart Association (NYHA) Functional Classification of Heart Failure Grade \> 3B 6. Uncontrolled diabetes, defined as hemoglobin A1c \> 7.4%. 7. BMI \> 45 8. Any acute illness within 14 days of Day 1 that could confound the evaluation of safety evaluation of TRL1068, especially local or systemic fungal and other known or suspected bacterial infections 9. Receiving or recently received another investigational drug (within 30 days of Day 1, or 5 half-lives of the investigational drug, whichever is longer) 10. Received any vaccine within 14 days prior to Day 1 11. Positive serum pregnancy test for WOCBP, or nursing women 12. History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with all study requirements 13. Any other comorbidity or condition that, in the opinion of the Investigator would make the patient unsuitable for the study or unable to comply with the study requirements.

Inclusion Criteria

Exclusion Criteria

1. Age 18 to 85 years, inclusive
2. Chronic PJI:
1. Systemic Host Grade of A or B \[McPherson 2011\] (Appendix 3) and either
2. First chronic PJI of the hip or knee, confirmed by synovial fluid aspirate culture or
3. Recurrent chronic PJI of the hip or knee confirmed by synovial fluid aspirate culture
3. Willing to be randomized to either:
1. Receive TRL1068 and to be scheduled for DAIR between Day 15 + 7 days (i.e., between days 15-22) and 10 weeks of targeted antibiotic treatment or
2. Participate in an observational study arm that receives SoC (i.e., two-stage prosthetic joint replacement) and
4. At least 1 positive bacterial culture without concomitant fungal infection from the infected joint (a joint aspirate within 28 days prior to Screening is acceptable)
5. All identified pathogen(s) are susceptible to the planned antibiotic regimen
6. Availability of radiology assessments of the affected joint without signs of loosening of the prosthesis or presence of osteomyelitis
7. Willing and able to provide written informed consent
8. Willing to perform and comply with all study procedures, including attending clinic visits as scheduled
9. Men and women of childbearing potential (WOCBP) must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine device (IUD), or use of spermicide combined with a barrier method (e.g., condom, diaphragm) through Day 365.

1. PJI associated with presence of concomitant fungal infection or bacterial pathogens that, even when in planktonic form (i.e., when released from biofilm), cannot be adequately treated with available antibiotics.
2. More than one draining sinus and single draining sinus of \> 1 cm
3. Less than 3 years life expectancy based on underlying morbidities
4. Expected to receive chronic suppressive antibiotic therapy
5. Congestive heart failure; New York Heart Association (NYHA) Functional Classification of Heart Failure Grade \> 3B
6. Uncontrolled diabetes, defined as hemoglobin A1c \> 7.4%.
7. BMI \> 45
8. Any acute illness within 14 days of Day 1 that could confound the evaluation of safety evaluation of TRL1068, especially local or systemic fungal and other known or suspected bacterial infections
9. Receiving or recently received another investigational drug (within 30 days of Day 1, or 5 half-lives of the investigational drug, whichever is longer)
10. Received any vaccine within 14 days prior to Day 1
11. Positive serum pregnancy test for WOCBP, or nursing women
12. History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with all study requirements
13. Any other comorbidity or condition that, in the opinion of the Investigator would make the patient unsuitable for the study or unable to comply with the study requirements.

Contacts and Locations

Study Contact

Anton Leighton, MD

CONTACT

650-838-1400

Clinicalstudies@trellisbio.com

Adriane Kisch-Hancock

CONTACT

650-838-1400

akisch-hancock@trellisbio.com

Study Locations (Sites)

UCLA

Los Angeles, California, 90024

United States

Gulfcoast Research Institute

Sarasota, Florida, 34232

United States

Phoenix Clinical Research

Tamarac, Florida, 33321

United States

Sinai Hospital Baltimore

Baltimore, Maryland, 21215

United States

M3 Wake Research Associates

Wilmington, North Carolina, 28412

United States

Houston Methodist

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Trellis Bioscience LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-12

Study Completion Date2026-11

Study Record Updates

Study Start Date2025-03-12

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

biofilm
antibiotic-resistant infections

Additional Relevant MeSH Terms

Prosthetic Joint Infections of Hip
Prosthetic Joint Infections of Knee