Набор скоро начнётся NCT07376889

Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia

Фаза IV С лечением Staphylococcus Aureus Bacteremia

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: Antibiotic Monotherapy (AM) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB), Antibiotic Monotherapy (AM) for patients with methicillin-resistant S. aureus bacteremia (MRSAB), Combination Antibiotic Therapy (CAT) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB), Combination Antibiotic Therapy (CAT) for patients with methicillin-resistant S. aureus bacteremia (MRSAB).
Кому может быть актуально: Состояния в реестре: Staphylococcus Aureus Bacteremia. 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

COMBAT-SAB: Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia

Обзор

The purpose of this study is to see if, in selected patients with a serious bacterial infection of the bloodstream, treating the bacterial infection with a combination of antibiotics is more effective than treating the infection with a single antibiotic. Participants must have blood cultures which are positive for a certain type of bacteria.

Подробное описание

Staphyloccocus aureus bacteremia (SAB) is a common infectious disease condition in hospitalized patients which is associated with significant morbidity, excessive costs, and high mortality, despite effective antibiotic therapy. This pragmatic study is designed to test the hypothesis that outcomes in adults hospitalized with SAB will be improved by using combination antibiotic therapy (CAT) as early, targeted therapy in a high-risk subgroup. A group of patients identified early in their course as meeting at least one high-risk criterion who have no contraindications will be treated with one of two antibiotic strategies commonly used within usual care, namely: 1) antibiotic monotherapy or 2) combination antibiotic therapy, depending on the random assignment for each hospital, each month. Low-risk patients will be treated per usual care. Data from all patients admitted to participating hospitals with SAB will be included in the analysis.

Вмешательства

Препарат Antibiotic Monotherapy (AM) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB)
Intravenous anti-staphylococcal beta-lactam, either cefazolin or nafcillin, per the discretion of the treating physician.
Препарат Antibiotic Monotherapy (AM) for patients with methicillin-resistant S. aureus bacteremia (MRSAB)
Vancomycin or daptomycin, per discretion of the treating physician
Препарат Combination Antibiotic Therapy (CAT) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB)
Patients with methicillin-sensitive S. aureus bacteremia (MSSAB) and no contraindications will receive an anti-staphylococcal beta-lactam, either cefazolin or nafcillin, plus ertapenem
Препарат Combination Antibiotic Therapy (CAT) for patients with methicillin-resistant S. aureus bacteremia (MRSAB)
Daptomycin plus ceftaroline

Первичные конечные точки

Desirability of Outcome Ranking (DOOR) [Срок оценки: From enrollment to 30 days post enrollment]

Вторичные конечные точки (10)

90-day hospital-free days alive [Срок оценки: From enrollment to 90 days after enrollment]
30-day all cause mortality [Срок оценки: From enrollment to 30 days after enrollment]
90-day all-cause mortality [Срок оценки: From enrollment to 90 days after enrollment]
30-day bacteremia-free days [Срок оценки: From enrollment to 30 days after enrollment]
Length of stay [Срок оценки: Measured at the time of hospital discharge, up to 30 days after enrollment]
Total hospital direct costs [Срок оценки: Measured at the time of hospital discharge, up to 30 days after enrollment]
Total inpatient antibiotic cost [Срок оценки: Measured at the time of hospital discharge, up to 30 days after enrollment]
Combination antibiotic days [Срок оценки: Measured from the time of enrollment until study day 7, death, or hospital discharge]
Antibiotic-associated adverse events [Срок оценки: From enrollment to 30 days after enrollment]
Clostridioides difficile infection [Срок оценки: From enrollment to 30 days after hospital discharge]

Критерии участия

Критерии включения

Age ≥18 years
Alive and admitted to an Intermountain Health (IH) hospital acute care unit at enrollment
Initial positive blood culture with either methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-susceptible Staphylococcus aureus (MSSA), collected:

on or during the index admission to an IH hospital, or
in an ambulatory setting (laboratory, clinic or emergency department) within 48 hours of the index admission, or
at a non-IH network hospital within 24 hours of subsequent transfer to an IH hospital