AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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
Show all 9Show fewer
  • 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.

Peptilogics RETAIN Study Lead contact

412-643-4924

ClinicalTrials@peptilogics.com

21 sites in 2 countries

United States16 sites, 14 recruiting

  • Clinical Trial Site

    Baltimore, Maryland, 21215

    Withdrawn

  • 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

    Recruiting

  • Clinical Trial Site

    New York, New York, 10032

    Withdrawn

  • 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

    Recruiting

Other trials in United States

United Kingdom5 sites, 5 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

    Recruiting

  • Clinical Trial Site

    Norwich, Norfolk, NR4 7UY

    Recruiting

Other trials in United Kingdom

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.

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 groups in NCT07214311
Study groupRoleWhat they receive
PLG0206ExperimentalPLG0206 will be administered as an irrigation solution during DAIR procedure
Receives: Drug: PLG0206
PlaceboPlacebo comparatorPlacebo (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.

  1. Reduction in Treatment Failure Post DAIR

    Proportion of participants with PJI treatment failure following DAIR

    Measured: From treatment through 12 months

Secondary outcomes (17)

  1. 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

  2. Safety of PLG0206

    Evaluation of adverse events

    Measured: From treatment through 12 months

  3. Survival

    Evaluation of PJI-related mortality rate

    Measured: From treatment through 12 months

  4. 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

  5. Time to Treatment Failure

    Evaluation on effect of PLG0206 on time to treatment failure

    Measured: From treatment through 12 months

  6. 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

  7. 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

  8. Microbiological Efficacy Outcome

    Evaluate the per-pathogen microbiological response rate following study drug administration

    Measured: From treatment through 12 months

  9. 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

  10. Immunogenicity of PLG0206

    Evaluation of anti-drug antibodies to PLG0206

    Measured: from Baseline through 12 months

  11. 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

  12. Maximum Plasma Concentration (Cmax) of PLG0206

    Measured: From Baseline through Day 2

  13. Time to Maximum Plasma Concentration (Tmax) of PLG0206

    Measured: Baseline through Day 2

  14. Half-life of PLG0206 in Plasma

    Measured: Baseline through Day 2

  15. 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

  16. 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

  17. 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.

  1. First posted9 Oct 2025
  2. Study start3 Feb 2026
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

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)
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
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PLG0206 in people with Prosthetic-joint Infection, run by Peptilogics at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peptilogics RETAIN Study Lead (412-643-4924, ClinicalTrials@peptilogics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Treatment Failure Post DAIR (time frame: From treatment through 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07214311.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in