Prosthetic-joint InfectionPhase 2/3RETAINNCT07214311
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
A Phase 2/3 study testing PLG0206 in people with Prosthetic-joint Infection, run by Peptilogics at 21 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Prosthetic-joint Infection
- What is being tested?
- PLG0206
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 3 Feb 2026to Sep 2028
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants age between 18 and <86 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
Who cannot join
- 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 confirmed PJI of the affected knee, including prior DAIR or revision surgery for PJI
- Two or more prior revisions in the affected joint for reasons other than infection
- Epithelialized sinus tract with evidence of communication to the joint or visualization of prosthesis
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- Diabetes mellitus and with an A1c ≥9% within 3 months, according to medical history
- 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)
Trial locations and contacts
21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 2 countries
United States16 sites, 14 recruiting
- Withdrawn
Clinical Trial Site
Baltimore, Maryland, 21215
- Recruiting
Clinical Trial Site
Boston, Massachusetts, 02120
- Recruiting
Clinical Trial Site
Cincinnati, Ohio, 45267
- Recruiting
Clinical Trial Site
Cleveland, Ohio, 44195
- Recruiting
Clinical Trial Site
Columbus, Ohio, 43210
- Recruiting
Clinical Trial Site
Dallas, Texas, 75390
- Recruiting
Clinical Trial Site
Edinburg, Texas, 78539
- Recruiting
Clinical Trial Site
Katy, Texas, 77494
- Recruiting
Clinical Trial Site
Leland, North Carolina, 28451
- Recruiting
Clinical Trial Site
Morgantown, West Virginia, 26506
- Withdrawn
Clinical Trial Site
New York, New York, 10032
- Recruiting
Clinical Trial Site
Pittsburgh, Pennsylvania, 15232
- Recruiting
Clinical Trial Site
Salt Lake City, Utah, 84132
- Recruiting
Clinical Trial Site
Sarasota, Florida, 34239
- Recruiting
Clinical Trial Site
Shreveport, Louisiana, 71103
- Recruiting
Clinical Trial Site
Tamarac, Florida, 33321
United Kingdom5 sites, 5 recruiting
- Recruiting
Clinical Trial Site
Cambridge, Cambridgeshire, CB2 0QQ
- Recruiting
Clinical Trial Site
Coventry, West Midlands, CV2 2DX
- Recruiting
Clinical Trial Site
Edinburgh, Lothian, EH16 4SA
- Recruiting
Clinical Trial Site
Leeds, West Yorkshire, LS7 4SA
- Not yet recruiting
Clinical Trial Site
Norwich, Norfolk, NR4 7UY
About this study
Official title: RETAIN: A Phase 2/3 Randomized, Placebo-Controlled Study to Evaluate the Efficacy of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Total Knee Arthroplasty (TKA)
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.
Read the detailed description
This study is designed to assess the efficacy and safety of PLG0206 administered intraoperatively by local irrigation to participants undergoing a DAIR procedure for treatment of Prosthetic Joint Infection (PJI) occurring after total knee arthroplasty (TKA), also known as knee joint replacement.
Eligible participants will undergo a DAIR procedure according to the treating hospital's standard of care (SOC). Participant eligibility will be based on clinical and diagnostic assessments, including laboratory results.
Once debridement during DAIR is complete, the Investigator will follow a standardized irrigation protocol, with the final irrigation step being administration of a single dose of blinded study drug (PLG0206 or matching placebo). The study drug will be administered as a single intra-articular irrigation.
Following study drug administration, all participants will receive standard post-operative care per institutional guidelines and will be discharged from the hospital in accordance with local standards. Participants may receive IV/oral antimicrobial therapy, as part of post-operative SOC.
Participants will be monitored for safety and signs of PJI recurrence or persistent infection for 365 days post study drug administration. After hospital discharge, study visits will occur in-clinic on Days 14, 90, and 365, and on Days 30, 180, and 270 via a telephone or virtual visit.
- Conditions
- Prosthetic-joint Infection
- Being tested
- PLG0206, Placebo
- Keywords
- PJI, TKA, DAIR, Joint Infection, Knee Replacement, Prosthetic Joint, Arthroplasty, PLG0206
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLG0206Drug
PLG0206 Solution
PlaceboDrug
Also called 0.9% sodium chloride
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PLG0206 | Experimental | PLG0206 will be administered as an irrigation solution during DAIR procedure Receives: Drug: PLG0206 |
| Placebo | Placebo comparator | Placebo (normal saline) will be administered as an irrigation solution during DAIR procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Treatment Failure Post DAIR
Proportion of participants with PJI treatment failure following DAIR
Measured: From treatment through 12 months
Secondary outcomes (17)
Reduction Rate of PJI-related Surgical Intervention
Proportion of participants with PJI requiring a PJI-related surgical intervention following DAIR
Measured: From treatment through 12 months
Safety of PLG0206
Evaluation of adverse events
Measured: From treatment through 12 months
Survival
Evaluation of PJI-related mortality rate
Measured: From treatment through 12 months
Efficacy of PLG0206 on Clinical Outcome
Evaluate the rate of PJI treatment failure at specific time points
Measured: At Days 14, 30, 90, 180, 270, and 365
Time to Treatment Failure
Evaluation on effect of PLG0206 on time to treatment failure
Measured: From treatment through 12 months
PJI-related Healthcare Resource Utilization
Evaluate the effect of PLG0206 on the need for medical care after post-DAIR procedure discharge
Measured: From treatment through 12 months
Frequency of PJI-related Surgical Procedures Following DAIR
Evaluate the number of surgical procedures for PJI treatment performed after the initial DAIR procedure
Measured: From treatment through 12 months
Microbiological Efficacy Outcome
Evaluate the per-pathogen microbiological response rate following study drug administration
Measured: From treatment through 12 months
Functional Change Post-DAIR
Evaluate the effect of PLG0206 on the functional change from baseline utilizing the Oxford Knee Scale, where total scores range from 0 (poorest function) to 48 (maximal function)
Measured: From Baseline through 9 months
Immunogenicity of PLG0206
Evaluation of anti-drug antibodies to PLG0206
Measured: from Baseline through 12 months
Effect of PLG0206 on the inflammatory biomarker C-reactive Protein
Evaluate the difference between the PLG0206 and placebo groups in normalization of C-reactive protein levels post treatment
Measured: Measured at Baseline and Days 14, 90, and 365
Maximum Plasma Concentration (Cmax) of PLG0206
Measured: From Baseline through Day 2
Time to Maximum Plasma Concentration (Tmax) of PLG0206
Measured: Baseline through Day 2
Half-life of PLG0206 in Plasma
Measured: Baseline through Day 2
Area Under the Concentration-time Curve Through Last Quantifiable Concentration
Characterization of systemic PK of PLG0206
Measured: From time O (pre-dose) through last quantifiable result; last protocol specified time-point is Day 2
Area Under the Concentration-time Curve Through Infinity
Characterization of systemic PK of PLG0206
Measured: From time O (pre-dose) to infinity [AUCinf]; last protocol specified time-point is Day 2
Concentration of PLG0206 in Irrigation Solution
Concentration of PLG0206 in irrigation solution at the end of study drug exposure
Measured: Measured at Study Day 1 at end of study drug exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start3 Feb 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic-joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peptilogics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214311
- Sponsor's protocol ID
- PLG0206-PJI-300
- Acronym
- RETAIN
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No