NCT07214311

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
28mo left

Started Feb 2026

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Feb 2026Sep 2028

First Submitted

Initial submission to the registry

September 18, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 9, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

February 3, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

September 18, 2025

Last Update Submit

March 6, 2026

Conditions

Prosthetic-joint Infection

Keywords

PJITKADAIRJoint InfectionKnee ReplacementProsthetic JointArthroplastyPLG0206

Outcome Measures

Primary Outcomes (1)

  • Reduction in Treatment Failure Post DAIR

    Proportion of participants with PJI treatment failure following DAIR

    From treatment through 12 months

Secondary Outcomes (17)

  • Reduction Rate of PJI-related Surgical Intervention

    From treatment through 12 months

  • Safety of PLG0206

    From treatment through 12 months

  • Survival

    From treatment through 12 months

  • Efficacy of PLG0206 on Clinical Outcome

    At Days 14, 30, 90, 180, 270, and 365

  • Time to Treatment Failure

    From treatment through 12 months

  • +12 more secondary outcomes

Study Arms (2)

PLG0206

EXPERIMENTAL

PLG0206 will be administered as an irrigation solution during DAIR procedure

Drug: PLG0206

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PLG0206DRUG

PLG0206 Solution

PLG0206
PlaceboDRUG

Placebo

Also known as: 0.9% sodium chloride
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Clinical Trial Site

Sarasota, Florida, 34239, United States

RECRUITING

Clinical Trial Site

Tamarac, Florida, 33321, United States

RECRUITING

Clinical Trial Site

Baltimore, Maryland, 21215, United States

RECRUITING

Clinical Trial Site

Boston, Massachusetts, 02120, United States

RECRUITING

Clinical Trial Site

Cincinnati, Ohio, 45267, United States

RECRUITING

Clinical Trial Site

Columbus, Ohio, 43210, United States

RECRUITING

Clinical Trial Site

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Peptilogics RETAIN Study Lead

CONTACT

412-643-4924ClinicalTrials@peptilogics.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2025

First Posted

October 9, 2025

Study Start

February 3, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

US(7)