Cellulitis Optimal Antibiotic Treatment
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: Flucloxacillin Only Product in Oral Dose Form, Placebo Only Product in Oral Dose Form.
- Кому может быть актуально
- Состояния в реестре: Cellulitis of Leg. 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
A Blinded, Non-inferiority Phase III Trial of 5 Versus 7 Days of Oral Flucloxacillin in Primary Care Patients With Lower Limb Cellulitis
Обзор
To determine whether a short course of oral flucloxacillin (5 days) is non-inferior to a standard course (7 days) in terms of pain over days 6-14 (indicative of persistence or recurrence associated with the symptoms of most importance to patients) in adults with cellulitis of the leg presenting in primary care.
Подробное описание
Cellulitis is a deep infection of the skin and subcutaneous tissues and most often occurs in the legs. It is a painful condition that is associated with inflammation and swelling of the site, and often systemic symptoms such as fever, headache, muscle aches, malaise, and fatigue. Patients report feeling unwell and that it has a significant impact on their mobility and ability to carry out their usual activities. NICE guidelines recommend oral flucloxacillin 500-1000 mg four times daily for 5-7 days as first-line treatment for most patients with cellulitis in the community, but most prescriptions are dispensed for a 7-day course. We will be assessing the effectiveness and safety of a 5-day treatment vs. the standard 7-day treatment. We also aim to evaluate the cost-consequences of a shorter course from an NHS and personal perspective. Participants will be randomly allocated to one of two groups. In addition to usual care, participants will either be assigned to a 5-day oral flucloxacillin course or a standard 7-day flucloxacillin course. Participants will be prescribed a 5-day course of oral flucloxacillin, and two additional tablets will be posted to the participants which will either be the antibiotic or a placebo tablet. Participants will be asked to fill out daily questionnaires and express their experiences with the shortened course and taking part in the trial.
Вмешательства
- Препарат Flucloxacillin Only Product in Oral Dose Form
Patients will be prescribed flucloxacillin 500mg QDS for 5 days followed by blinded flucloxacillin 500mg for 2 days, reaching a total of 7 days of antibiotic treatment - Препарат Placebo Only Product in Oral Dose Form
Patients will be prescribed flucloxacillin 500mg QDS for 5 days followed by a blinded placebo for 2 days, reaching a total of 5 days of antibiotic treatment
Первичные конечные точки
- Pain assessment [Срок оценки: Days 7-16]
Вторичные конечные точки (10)
- Use of additional antibiotics [Срок оценки: Up to day 28]
- Patient-reported assessment of how well they are feeling [Срок оценки: Days 6-14]
- Health related quality of life [Срок оценки: Days 6-14]
- Health related quality of life used to estimate Quality Adjusted- Life Years (QALYs) [Срок оценки: Days 6-14]
- Leg swelling and warmth [Срок оценки: Day 7, 14, 21, 28]
- Time until self-reported recovery [Срок оценки: Day 7, 14, 21, 28]
- Time until self-assessed extent of cellulitis starts to reduce (with no subsequent increase) [Срок оценки: Day 7, 14, 21, 28]
- Hospital admissions [Срок оценки: 12 months]
- Recurrent cellulitis episodes over 12 months (number of episodes) [Срок оценки: 12 months]
- Complications over 12 months [Срок оценки: 12 months]
Критерии участия
Критерии включения
- Must be aged 18 years or older
- Currently showing symptoms of cellulitis (such as pain, tenderness, redness, other change in skin color, warmth to touch) in one leg for 10 days or less
- Pain rated as 3/10 or higher on a numerical rating scale (0-10) at baseline assessment
- Be willing to be randomized to either trial arm (5-day or 7-day treatment)
- Able to complete trial procedures in the English language.
Критерии исключения
- Have penicillin allergy
- Have bilateral cellulitis
- Have had antibiotics for cellulitis within the past month
- Have post-operative cellulitis (within 30 days of operative procedures on the same leg)
- Have cellulitis resulting from human/animal bite injury
- Have Cellulitis associated with chronic (>6 weeks) leg ulceration
- Require immediate hospital admission or out-patient intravenous antibiotic therapy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Великобритания · 1 центр
- Royal South Hants Hospital — Southampton
Идентификаторы
NCT: NCT05584007 · ERGO 67073