Joint InfectionPhase 1NCT05137314
Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)
A Phase 1 study testing PLG0206 in people with Joint Infection, run by Peptilogics at 12 sites in United States.
Trial summary
The purpose of this study is to learn about the safety and effects of PLG0206 for treating periprosthetic joint infections (PJI) in conjunction with the DAIR (debridement, antibiotics and implant retention) surgical procedure for patients with periprosthetic joint infections (PJI) after total knee arthroplasty (TKA) . Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Joint Infection
- What is being tested?
- PLG0206
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 12 sitesUnited States
- Study dates
- 31 Mar 2022to 19 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with well-fixed prosthesis;
- Patients who have a pre- or intra-operative diagnosis of TKA-PJI
Who cannot join
- Patients for whom a DAIR procedure is not indicated;
- Patients with loose prosthesis and/or surgical treatment requiring removal of well-fixed, non-modular implants at screening;
- Patients with previous history or presence of osteomyelitis in the index limb;
- Patients who have uncontrolled diabetes mellitus;
- Patients with body mass index >50 kg/m2 at screening;
- Patients who are immunosuppressed;
- Patients who require therapeutic anticoagulation and/or antiplatelet therapy
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
LifeBridge
Baltimore, Maryland, 21215
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic
Cleveland, Ohio, 44106
Ohio State University
Columbus, Ohio, 43203
Memorial Hermann Hospital
Houston, Texas, 77030
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
WVU
Morgantown, West Virginia, 26501
NYU Langone Orthopedic Hospital
New York, New York, 10003
Stanford Hospital
Palo Alto, California, 94305
Rothman
Philadelphia, Pennsylvania, 19107
University of Utah Orthopaedic Center
Salt Lake City, Utah, 44106
Gulfcoast Research
Sarasota, Florida, 34232
About this study
Official title: A Phase 1b Open-Label, Dose-Escalating Study to Evaluate the Safety and Tolerability of PLG0206 in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)
The purpose of this study is to learn about the safety and effects of PLG0206 for treating periprosthetic joint infections (PJI) in conjunction with the DAIR (debridement, antibiotics and implant retention) surgical procedure for patients with periprosthetic joint infections (PJI) after total knee arthroplasty (TKA) .
Read the detailed description
Peptilogics, Inc. is developing PLG0206 for the treatment of PJIs. PLG0206 is an engineered antibacterial peptide (EAP) based on naturally-occurring antimicrobial peptides (AMPs). Recent work on PLG0206 has documented that PLG0206 is a highly effective anti-biofilm agent, in addition to its established activity against planktonic staphylococcus, both in vitro and in a murine animal model of PJI.
PLG0206 will be investigated in this study for treatment of PJI in conjunction with the DAIR procedure followed by the 6-week course of antimicrobial therapy that is standard-of-care (SOC) in this indication.
Patients will be followed for approximately 1 year post treatment.
- Conditions
- Joint Infection
- Being tested
- PLG0206
- Keywords
- PJI, knee infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLG0206Drug
PLG0206 is an engineered antibacterial peptide (EAP)
| Study group | Role | What they receive |
|---|---|---|
| 3 mg/mL PLG0206 | Experimental | administered intraoperatively by local irrigation Receives: Drug: PLG0206 |
| 10 mg/mL PLG0206 | Experimental | administered intraoperatively by local irrigation Receives: Drug: PLG0206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of treatment emergent AEs
the safety and tolerability of PLG0206 administered via an irrigation solution for the treatment of a PJI occurring after TKA during DAIR.
Measured: approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start31 Mar 2022
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Open-Label, Dose-Escalating
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peptilogics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, Wellcome Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137314
- Sponsor's protocol ID
- PLG0206-PJI-101
- Status last verified
- May 2025
- First submitted
- 28 Oct 2021
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Open-Label, Dose-Escalating Study to Evaluate the Safety and Tolerability of PLG0206 in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT05137314
- Acronym / sponsor ID
- PLG0206-PJI-101
- Conditions
- Joint Infection
- Keywords
- PJI, knee infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- PeptilogicsIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, Wellcome Trust
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the safety and effects of PLG0206 for treating periprosthetic joint infections (PJI) in conjunction with the DAIR (debridement, antibiotics and implant retention) surgical procedure for patients with periprosthetic joint infections (PJI) after total knee arthroplasty (TKA) .
Detailed description
Peptilogics, Inc. is developing PLG0206 for the treatment of PJIs. PLG0206 is an engineered antibacterial peptide (EAP) based on naturally-occurring antimicrobial peptides (AMPs). Recent work on PLG0206 has documented that PLG0206 is a highly effective anti-biofilm agent, in addition to its established activity against planktonic staphylococcus, both in vitro and in a murine animal model of PJI.
PLG0206 will be investigated in this study for treatment of PJI in conjunction with the DAIR procedure followed by the 6-week course of antimicrobial therapy that is standard-of-care (SOC) in this indication.
Patients will be followed for approximately 1 year post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-Label, Dose-Escalating
| Arm | Type | Receives |
|---|---|---|
| 3 mg/mL PLG0206 | Experimental | Drug: PLG0206administered intraoperatively by local irrigation |
| 10 mg/mL PLG0206 | Experimental | Drug: PLG0206administered intraoperatively by local irrigation |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with well-fixed prosthesis;
- Patients who have a pre- or intra-operative diagnosis of TKA-PJI
Key exclusion criteria (7 listed)
- Patients for whom a DAIR procedure is not indicated;
- Patients with loose prosthesis and/or surgical treatment requiring removal of well-fixed, non-modular implants at screening;
- Patients with previous history or presence of osteomyelitis in the index limb;
- Patients who have uncontrolled diabetes mellitus;
- Patients with body mass index >50 kg/m2 at screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLG0206PLG0206 is an engineered antibacterial peptide (EAP) | Drug | 10 mg/mL PLG0206, 3 mg/mL PLG0206 |
Primary outcome
The percentage of treatment emergent AEs
Time frame: approximately 1 year
the safety and tolerability of PLG0206 administered via an irrigation solution for the treatment of a PJI occurring after TKA during DAIR.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PLG0206 in people with Joint Infection, run by Peptilogics at 12 sites in United States.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of treatment emergent AEs (time frame: approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2025.