Идёт набор NCT06746883

A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection

— Наблюдательное Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)

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: Non-interventional.
Кому может быть актуально: Состояния в реестре: Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC). 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

A Single-arm, Open-label, Prospective, Observational Study to Assess the Safety of Sulbactam-durlobactam, Including the Risk of Hypersensitivity Reactions (Including Anaphylaxis) in Participants With Acinetobacter Baumannii-calcoaceticus Complex Infection

Обзор

The goal of this observational study is to evaluate the safety of sulbactam-durlobactam, as well as the risk of hypersensitivity reactions (including anaphylaxis) in participants with Acinetobacter baumannii-calcoaceticus complex infection. Participants will be followed for approximately 28 days in order to collect safety and reaction data.

Вмешательства

Другое Non-interventional
Non-interventional

Первичные конечные точки

Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs) defined as any event after exposure to sulbactam-durlobactam (SUL-DUR), or event already present that worsens in either intensity or frequency after exposure [Срок оценки: 28 days]
Number of participants experiencing TEAEs [Срок оценки: 28 days]
Incidence of maximum severity level of TEAEs [Срок оценки: 28 days]
Incidence of related TEAEs as assessed by the investigator. [Срок оценки: 28 days]
Incidence of serious TEAEs [Срок оценки: 28 days]
Percentage of participants experiencing Adverse Events of Special Interest (AESIs) defined as an AE or SAE of concern specific to the sponsor, for which ongoing monitoring is needed. AESIs include: Hypersensitivity reactions, including anaphylaxis. [Срок оценки: 28 days]
Number of participants experiencing AESIs [Срок оценки: 28 days]
Incidence of maximum severity level of AESIs [Срок оценки: 28 days]
Incidence of related AESIs as assessed by the investigator [Срок оценки: 28 days]
Incidence of serious AESIs [Срок оценки: 28 days]

Вторичные конечные точки (12)

Actual observed values over time of liver function tests [Срок оценки: Baseline and Day 28]
Change from baseline values of liver function tests [Срок оценки: Day 28]
Actual observed values over time of systolic blood pressure [Срок оценки: Baseline and Day 28]
Change from baseline values over time of systolic blood pressure [Срок оценки: Day 28]
Actual observed values over time of diastolic blood pressure [Срок оценки: Baseline and Day 28]
Change from baseline values of diastolic blood pressure [Срок оценки: Day 28]
Actual observed values over time of temperature [Срок оценки: Baseline and Day 28]
Change from baseline values of temperature [Срок оценки: Day 28]
Actual observed values over time of pulse rate [Срок оценки: Baseline and Day 28]
Change from baseline values of pulse rate [Срок оценки: Day 28]
Actual observed values over time of respiration rate [Срок оценки: Baseline and Day 28]
Change from baseline values of respiration rate [Срок оценки: Day 28]

Критерии участия

Критерии включения

Participant is ≥18 years old at the time of written informed consent and is hospitalized.
Participant has provided the written informed consent. If a participant is unable to provide written informed consent due to their medical condition, the participant's legally authorized representative may consent on behalf of the participant, or the decision can be made according to the procedure permitted by local law and institutional standard operating procedures (SOPs).
Participant has a proven or strongly suspected diagnosis of an infection caused by susceptible ABC isolates, based on investigator's clinical judgment.
Participant initiates treatment with SUL-DUR per routine clinical care. Participants who receive SUL-DUR within 24 hours prior to enrollment are also eligible to participate. The decision to treat the participant with SUL-DUR is made prior to and independently of study participation.
The participant has an expected survival of >48 hours at the time of written informed consent.