Идёт набор NCT07214311

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

Фаза II / Фаза III С лечением Prosthetic-joint Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: PLG0206, Placebo.
Кому может быть актуально: Состояния в реестре: Prosthetic-joint Infection. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

Препарат PLG0206
PLG0206 Solution
Препарат Placebo
Placebo

Первичные конечные точки

Reduction in Treatment Failure Post DAIR [Срок оценки: From treatment through 12 months]

Вторичные конечные точки (12)

Reduction Rate of PJI-related Surgical Intervention [Срок оценки: From treatment through 12 months]
Safety of PLG0206 [Срок оценки: From treatment through 12 months]
Survival [Срок оценки: From treatment through 12 months]
Efficacy of PLG0206 on Clinical Outcome [Срок оценки: At Days 14, 30, 90, 180, 270, and 365]
Time to Treatment Failure [Срок оценки: From treatment through 12 months]
PJI-related Healthcare Resource Utilization [Срок оценки: From treatment through 12 months]
Frequency of PJI-related Surgical Procedures Following DAIR [Срок оценки: From treatment through 12 months]
Microbiological Efficacy Outcome [Срок оценки: From treatment through 12 months]
Functional Change Post-DAIR [Срок оценки: From Baseline through 9 months]
Immunogenicity of PLG0206 [Срок оценки: from Baseline through 12 months]
Effect of PLG0206 on the inflammatory biomarker C-reactive Protein [Срок оценки: Measured at Baseline and Days 14, 90, and 365]
Maximum Plasma Concentration (Cmax) of PLG0206 [Срок оценки: From Baseline through Day 3]

Критерии участия

Критерии включения

Male or female participants age between 18 and <80 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

Критерии исключения

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 PJI of the affected knee
Two or more prior revisions in the affected joint
Epithelialized sinus tract with evidence of communication to the joint or visualization of prosthesis
Diabetes mellitus and with an A1c ≥9%
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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет