Идёт набор NCT04538053

BonE and Joint Infections - Simplifying Treatment in Children Trial

Фаза IV С лечением Bone Infection Septic Arthritis Bone and Joint Infection Osteomyelitis

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: Oral cefalexin only, IV cefazolin or IV flucloxacillin followed by oral cefalexin.
Кому может быть актуально: Состояния в реестре: Bone Infection, Septic Arthritis, Bone and Joint Infection, Osteomyelitis. Базовые параметры: 1 год — 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: Австралия, Новая Зеландия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.

Подробное описание

Children with acute onset BJIs who present to the participating sites will be enrolled into the trial if eligible (see eligibility criteria) and randomly allocated into two groups. Children in the 'standard treatment group' will receive standard treatment for BJIs, which consists of IV antibiotics for 1-7 days followed by 3 weeks of oral antibiotics. Children in the 'entirely oral treatment group' will receive high dose oral antibiotics, followed by the standard dose of oral antibiotics for 3 weeks. The outcomes of children in each of the two groups will be compared to determine whether BJIs can be treated without needing a course of IV antibiotics.

Вмешательства

Препарат Oral cefalexin only
High-dose oral cefalexin
Препарат IV cefazolin or IV flucloxacillin followed by oral cefalexin
Standard therapy of IV cefazolin or IV flucloxacillin followed by high dose oral cefalexin

Первичные конечные точки

Proportion of children assessed as having made a full recovery 3 months [Срок оценки: 3 months]

Вторичные конечные точки (12)

Proportion of children with with recurrent disease at 6 months. [Срок оценки: 6 months]
Proportion of children with with recurrent disease at 12 months. [Срок оценки: 12 months]
Proportion of children with complications of their disease at 3 months. [Срок оценки: 3 months]
Proportion of children with complications of their disease at 12 months. [Срок оценки: 12 months]
Proportion of children with treatment-related adverse effects (AEs). [Срок оценки: Between Day 1-7]
Quality of life - Pediatric Quality of Life Inventory (PedsQL) 3 months [Срок оценки: 3 months]
Quality of life - Child Health Utility Scale (CHU9D) Day 8-14 [Срок оценки: Once between Day 8 to Day 14]
Quality of life - Child Health Utility Scale (CHU9D) 12 months [Срок оценки: 12 months]
Quality of life - EQ-5d Day 8-14 [Срок оценки: Once between Day 8 to Day 14]
Cost effectiveness - cost-effectiveness ratio of all resources at 12 months [Срок оценки: 12 months]
Treatment adherence - medication reconciliation at 3 weeks [Срок оценки: Week 3]
Treatment adherence - Medication Adherence Response Scale at 3 weeks [Срок оценки: Week 3]

Критерии участия

Критерии включения

Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.

Критерии исключения

Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal)
Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score)
Concomitant severe, invasive infection e.g. necrosing fasciitis
Complicated infection (e.g. presence of prosthetic material; large subperiosteal (>3mm) or soft tissue abscess without surgical intervention; infection secondary to or complicated by trauma)
History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins
Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection
Prior episode of OM or SA
Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency)
Prior enrolment in the trial
Current recipient of another investigational product as part of a clinical trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет