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Antibiotic

PLG0206 for Joint Infections After Knee Replacement

Phase 1
Recruiting
Research Sponsored by Peptilogics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year
Awards & highlights

Study Summary

This trial is studying the safety and efficacy of PLG0206 in treating patients with periprosthetic joint infections (PJI) after total knee arthroplasty (TKA) using the DAIR surgical procedure.

Who is the study for?
This trial is for patients who have a joint infection after knee replacement surgery and are undergoing the DAIR procedure. Eligible participants must have a stable knee implant but can't join if they have bone infections, need blood thinners, have loose implants needing removal, are severely overweight, immunosuppressed or have uncontrolled diabetes.Check my eligibility
What is being tested?
The study tests PLG0206's safety and effectiveness when used with the DAIR surgical method in treating joint infections following knee replacement surgery. It aims to see how well this drug works alongside standard procedures for these infections.See study design
What are the potential side effects?
While specific side effects of PLG0206 aren't detailed here, common risks may include allergic reactions to the medication, potential interference with healing post-surgery, and typical complications from antibiotics like stomach upset or increased risk of other infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The percentage of treatment emergent AEs

Trial Design

2Treatment groups
Experimental Treatment
Group I: 3 mg/mL PLG0206Experimental Treatment1 Intervention
administered intraoperatively by local irrigation
Group II: 10 mg/mL PLG0206Experimental Treatment1 Intervention
administered intraoperatively by local irrigation

Find a Location

Who is running the clinical trial?

Wellcome TrustOTHER
214 Previous Clinical Trials
15,673,025 Total Patients Enrolled
Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,935 Total Patients Enrolled
PeptilogicsLead Sponsor

Media Library

PLG0206 (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05137314 — Phase 1
Joint Infections Research Study Groups: 3 mg/mL PLG0206, 10 mg/mL PLG0206
Joint Infections Clinical Trial 2023: PLG0206 Highlights & Side Effects. Trial Name: NCT05137314 — Phase 1
PLG0206 (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05137314 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a wide distribution of study centers in this urban area?

"There are 7 sites offering this medical trial, including Cleveland Clinic in Cleveland, Ohio State University in Columbus and University of Utah Orthopaedic Center in Salt Lake City. Additionally, other clinical centres are also running the same study."

Answered by AI

What safety measures have been implemented for PLG0206 recipients?

"Our experts at Power ranked PLG0206's safety as a 1 due to the lack of clinical data proving its effectiveness and limited evidence for it being safe."

Answered by AI

What are the criteria for enrollment in this research project?

"This medical study is looking to include 14 individuals ranging between 18 and 79 years old who are suffering from joint infections. Furthermore, the study requires that patients have a securely fastened prosthesis as well as pre- or intra-operative diagnosis of TKA-PJI."

Answered by AI

How many participants have signed up for this investigation?

"This clinical trial requires the recruitment of 14 individuals meeting certain inclusion criteria. The Ohio region is home to two possible sites for participation, namely Cleveland Clinic in Cleveland and Ohio State University in Columbus."

Answered by AI

Are younger participants allowed to partake in this experiment?

"This clinical trial is seeking patients between the ages of 18 to 79. Nonetheless, there are 200 separate studies for minors and 611 additional trials available for individuals over 65 years old."

Answered by AI

Are there any openings within this research project?

"Affirmative. According to the clinicaltrials.gov database, this medical trial is actively seeking participants, having first been posted on March 31st 2022 and subsequently updated on August 30th 2022. The study requires 14 volunteers from 7 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Occurring After Total Knee Arthroplasty (TKA)
2022. "Study 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. https://clinicaltrials.gov/ct2/show/NCT05137314.
~5 spots leftby Apr 2025
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