Trial intelligence / Profile preview

PLG0206 in Prevention of Recurrent Infection in Patients Undergoing DAIR for PJI Following TKA

NCT07214311Phase 3

Key facts

Status: Recruiting
Start: Feb 2026
Primary completion: Sep 2028
Countries: 2
Sponsor: Peptilogics

Drugs: zaloganan
Conditions: prosthetic joint infection (PJI)

Overview

Phase 3, randomised, double-blind trial in prosthetic joint infection (PJI) comparing PLG0206 with Placebo (2 arms). Primary endpoint: Reduction in Treatment Failure Post DAIR at 12 months. Started Feb 2026; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

PLG0206
PLG0206 administered as an irrigation solution during DAIR procedure
Placebo
Placebo (normal saline) administered as an irrigation solution during DAIR procedure

Who it enrols

Adults with suspected or confirmed PJI of the knee indicated for a single DAIR procedure, with a well-fixed prosthesis. Excludes patients requiring >6 months of antibiotics post-DAIR, with infection spread beyond the joint, prior PJI of the affected knee, poorly controlled diabetes, recent history of malignancy with immunosuppressive therapy, or known immunodeficiency.

Endpoints

Primary

Reduction in Treatment Failure Post DAIR12 months

Secondary

Reduction Rate of PJI-related Surgical Intervention12 months
Safety of PLG020612 months
Overall Survival12 months
Efficacy of PLG0206 on Clinical Outcome365 days
Time to Treatment Failure12 months
PJI-related Healthcare Resource Utilization12 months
Frequency of PJI-related Surgical Procedures Following DAIR12 months
Microbiological Efficacy Outcome12 months

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