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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

Study acronym: RETAIN
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site details revised at 1 of 19 sites
  2. Study sites: 17 to 19
  3. Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 5 of 17 entries
  4. Study sites: 16 to 17v17
  5. Study sites: 15 to 16v16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 14 to 15v15
  2. Study sites: 13 to 14v14
  3. Study sites: 12 to 13v13
  4. Study sites: 11 to 12v12
  5. Study sites: 9 to 11v11
  6. Study sites: 8 to 9v10
  7. Study sites: 7 to 8v9
  8. Study sites: 6 to 7v8
  9. Primary completion date: Jun 2028 to Sep 2028
    • Start date changed from estimate of Jan 2026 to Feb 3, 2026
    v7
  10. Study sites: 5 to 6v6
  11. Study sites: 3 to 5
    • Start date: Dec 2025 to Jan 2026
    v5
  12. Study sites: 2 to 3v4
  13. Study sites: 1 to 2v3
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: 16 to 17
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07214311
Lead Sponsor Peptilogics
Conditions
(from sponsor)		 Prosthetic-joint Infection
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov