Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Infections, Bacterial, Pharmacokinetics, Drug Monitoring, Drug-Related Side Effects and Adverse Reactions. 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
- 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
Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management
Обзор
The primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.
Подробное описание
To address the challenge of antimicrobial resistance (AMR) it is imperative that the current finite pool of antimicrobial agents is optimised, to maximise therapeutic success, limit the risk of drug toxicity, whilst minimising emergence of resistance.
Outside of the critical care setting it is not known how many patients are receiving optimal drug concentrations for the treatment of infection.
This study aims to assess whether antimicrobial targets are being achieved in these individuals and explore how clinical co-variates and outcomes may relate to this. Furthermore, it aims to identify priority groups and/or drugs where there are gaps in dose optimisation research and develop hypotheses which can be tested in observational studies.
Eligible participants will be enrolled and observed during their management of infection at Imperial College NHS Trust. After providing informed consent their clinical data will be collected from electronic healthcare records and they will provide samples that will undergo drug concentration analysis.
Первичные конечные точки
- Determine the number of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved. [Срок оценки: 3 years]
Вторичные конечные точки (5)
- Find the number of individuals receiving co-administered non-beta-lactam antibiotics in whom drug concentration targets are achieved. [Срок оценки: 3 years]
- Show how clinical co-variates, co-administered medications and treatment outcomes relate to target attainment, and identify groups of patients in who therapeutic drug monitoring may be beneficial. [Срок оценки: 3 years]
- Illustrate dynamic patterns of infection-related biomarkers which may indicate the presence/absence of treatment response. [Срок оценки: 3 years]
- Show how drug-levels obtained through minimally invasive sampling and the use of residual specimens relate to blood, and how these could be used to inform individual dose-optimisation. [Срок оценки: 3 years]
- Build a repository of real life PK-PD data which can be used to generate hypotheses and guide the development of interventional dose optimisation studies [Срок оценки: 3 years]
Критерии участия
Критерии включения
18 years of age or above.
- Under follow-up for management of infection at Imperial College NHS Trust
- Received a beta-lactam antibiotic within the last 48 hours (or are planned to start imminently).
- Provides informed written consent see below, or lacks capacity to provide consent because of one of the following conditions (and declaration provided by personal consultee):
- Delirium which may be caused or exacerbated by having an infection.
- Suspected/confirmed central nervous system infection.
- Critical illness requiring sedation and/or intubation and ventilation which is caused by or exacerbated by having an infection.
Критерии исключения
- Less than 18 years of age
- Severe anaemia (Hb < 70g/l)
- Platelets < 50x10\^9/l, INR >1.5 or other known blood clotting impairment
- Patient with terminal diagnosis receiving palliative care input who may experience distress if approached for this study.
- Enrolled in a clinical trial which stipulates exclusion from other studies including observational studies.
- Patients with restricted liberty, prisoners or under legal protection.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Великобритания · 1 центр
- Imperial College Healthcare NHS Trust — London
Идентификаторы
NCT: NCT06427317 · 21HH7287