Allergy Delabeling in Antibiotic Stewardship - Intervention
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: RENEW-IN Algorithm for assessment of a beta-lactam intervention, EMR Review.
- Кому может быть актуально
- Состояния в реестре: Beta Lactam Allergy, Hematologic Malignancy. Базовые параметры: от 18 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
- 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
Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy - Intervention
Обзор
The overall goal of the RENEW-IN intervention is to assess the impact of a BL allergy delabeling intervention on antibiotic use and clinical outcomes in patients with a hematologic malignancy.
Подробное описание
The RENEW clinical intervention is designed to evaluate the impact of a comprehensive beta lactam allergy delabeling intervention on clinical outcomes among patients hospitalized with a hematologic malignancy (HM).
HM patients are at a high risk of infection-related complications but are limited to antibiotic therapy based on self-reported allergies.
Beta-lactam (BL) antibiotics are a preferred treatment option for many bacterial infections, however, these antibiotics remain inaccessible as a treatment option for patients with a self-reported BL allergy. In the hospital setting, BL allergies are documented in the electronic medical record in up to 20% of hospitalized patients. Prior studies have shown that 90% of the patients for whom these allergies are reported are able to tolerate penicillin (PCN) or other BLs. Delabeling strategies to correctly identify true BL allergies in the general hospital population have proven successful. However, these studies have not been conducted among patients diagnosed with a hematological malignancy. The investigators propose to test the impact of a pharmacist-led BL allergy delabeling intervention on clinical outcomes and antibiotic use in hospitalized patients with HM.
The intervention is a multi-step PCN delabeling strategy that includes 1) an assessment of the participant's BL allergy by a clinical pharmacist based on a detailed medical history; 2) assignment of additional allergy testing based on the RENEW-IN algorithm; and 3) delabeling of the allergy within the participants electronic medical record if appropriate.
Вмешательства
- Диагностический тест RENEW-IN Algorithm for assessment of a beta-lactam intervention
The RENEW-IN intervention includes a detailed assessment of the participant's beta-lactam allergy history and determination of a risk-level for allergy-delabeling. - Другое EMR Review
Electronic medical record review for comparative analysis
Первичные конечные точки
- Antibiotic Days of therapy [Срок оценки: From baseline enrollment to end of index hospitalization or death, up to 36 months]
- Hospital length of stay [Срок оценки: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
Вторичные конечные точки (6)
- Clinical Cultures positive for multi-drug resistant organisms [Срок оценки: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
- Clinical Cultures positive for Clostridioides difficile infection [Срок оценки: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
- Clinical Cultures positive for Health-care Associated Infections (HAIs) [Срок оценки: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
- Need for ICU transfer [Срок оценки: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
- ICU length of stay [Срок оценки: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
- Patient Disposition [Срок оценки: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
Критерии участия
Критерии включения
- all patients with a hematologic malignancy (including Hodgkin and non-Hodgkin lymphoma, leukemia, and myeloma) admitted to an inpatient oncology service
- reported history of a beta-lactam (BL) allergy (i.e., penicillin, cephalosporin, and/or carbapenem)
Критерии исключения
- patients with a history of severe cutaneous adverse reaction
- patients with a history of Stevens-Johnson syndrome
- patients with a history of toxic epidermal necrolysis
- patients with a history of drug-induced exfoliative dermatitis
- patients with a history of drug reaction with eosinophilia and systemic symptoms
- patients with a history of acute generalized exanthematous pustulosis
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- Hospital of the University of Pennsylvania — Philadelphia
Идентификаторы
NCT: NCT07133074 · 01725 · R01HS029879