Recruiting
Phase 2
Phase 3

PLG0206

Sponsor:

Peptilogics

Code:

NCT07214311

Conditions

Prosthetic-joint Infection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PLG0206

Placebo

Study Details

Brief summary:

The goal of this clinical trial is to evaluate whether the investigational drug PLG0206 can help reduce recurrence of infection in adults who have undergone total knee replacement and are receiving a DAIR (Debridement, Antibiotics, and Implant Retention) surgical procedure to treat a Prosthetic Joint Infection (PJI). The study will also assess the safety of PLG0206 when used as an irrigation solution during the DAIR procedure.

Participants will receive either PLG0206 or a placebo (an inactive substance that looks like the investigational drug), in addition to standard of care treatments. All participants will be monitored for approximately one year following their DAIR procedure.

Conditions

Prosthetic-joint Infection

Study ID

NCT07214311

Start date

Feb 3, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female participants age between 18 and <80 years
  • Able to provide informed consent, geographically stable, and able to comply with the required follow-up visits
  • Suspected or confirmed PJI of the knee
  • Well-fixed and positioned prosthesis and good condition of surrounding soft tissue (no sinus tract)
  • A single DAIR procedure is indicated as treatment of PJI
  • Agree to use contraceptives if of childbearing potential

Exclusion Criteria:

  • Loose prosthesis or surgical treatment planned for removal of well-fixed, nonmodular implants
  • Anticipated to require antibiotic therapy for >6 months after DAIR procedure
  • Infection spread beyond the affected knee joint (e.g., osteomyelitis)
  • History of a prior PJI of the affected knee
  • Two or more prior revisions in the affected joint
  • Epithelialized sinus tract with evidence of communication to the joint or visualization of prosthesis
  • Diabetes mellitus and with an A1c ≥9%
  • History of malignant disease and having received immunosuppressive therapy, radiation therapy, or chemotherapy within the past year
  • Known immunodeficiency (e.g., splenectomy; sickle cell anemia; human immunodeficiency virus \[HIV\] with recent CD4 count <200 cells/mm3; or primary humoral, bone marrow, or other transplantation)

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PLG0206

PLG0206 will be administered as an irrigation solution during DAIR procedure

placebo comparator: Placebo

Placebo (normal saline) will be administered as an irrigation solution during DAIR procedure

Interventions

PLG0206

PLG0206 Solution

Placebo

Placebo

Primary outcome measure

  • Reduction in Treatment Failure Post DAIR [ Time Frame: From treatment through 12 months ]

Central Contacts and Locations

Central contacts

Peptilogics RETAIN Study Lead

412-643-4924ClinicalTrials@peptilogics.com

Locations

Clinical Trial Site

Recruiting

Sarasota, Florida, United States, 34239

Clinical Trial Site

Recruiting

Tamarac, Florida, United States, 33321

Clinical Trial Site

Recruiting

Shreveport, Louisiana, United States, 71103

Clinical Trial Site

Recruiting

Baltimore, Maryland, United States, 21215

Clinical Trial Site

Recruiting

Boston, Massachusetts, United States, 02120

Clinical Trial Site

Recruiting

New York, New York, United States, 10032

Clinical Trial Site

Recruiting

Leland, North Carolina, United States, 28451

Clinical Trial Site

Recruiting

Cincinnati, Ohio, United States, 45267

Clinical Trial Site

Recruiting

Cleveland, Ohio, United States, 44195

Clinical Trial Site

Recruiting

Columbus, Ohio, United States, 43210

Clinical Trial Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Clinical Trial Site

Recruiting

Dallas, Texas, United States, 75390

Clinical Trial Site

Recruiting

Edinburg, Texas, United States, 78539

Clinical Trial Site

Recruiting

Salt Lake City, Utah, United States, 84132

Clinical Trial Site

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

Peptilogics

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • PJI
  • TKA
  • DAIR
  • Joint Infection
  • Knee Replacement
  • Prosthetic Joint
  • Arthroplasty
  • PLG0206

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Peptilogics on 2026-08-19.