Меню
Идёт набор NCT06250023

SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

— Наблюдательное Osteomyelitis; Vertebra

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: Early shift til oral antibiotic treatment for osteomyelitis.
Кому может быть актуально
Состояния в реестре: Osteomyelitis; Vertebra. 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Early Shift to Oral Antibiotic Treatment for Pyogenic Vertebral Osteomyelitis (SAVE) - a Open Label Non-inferiority Nation-wide Study

Обзор

Background The current Danish National Guideline for treatment of pyogenic vertebral osteomyelitis (PVO) recommends 6 weeks antibiotic (AB) treatment, with a 2-week intravenous (IV) AB lead-in followed by 4 weeks oral AB for uncomplicated PVO, and 12 weeks AB treatment with a 2-4-week IV AB lead-in followed by 8 weeks oral AB for complicated PVO. The primary objective of the current study is to investigate whether shortening the duration of IV AB to one week for both complicated and uncomplicated PVO is non-inferior to the current Danish National Guideline.

Вмешательства

  • Другое Early shift til oral antibiotic treatment for osteomyelitis
    To investigate whether early transition to oral AB treatment after one week of IV treatment is non-inferior to the current national guideline of continued IV AB treatment for two to four weeks followed by oral AB treatment for PVO.

Первичные конечные точки

  • Primary outcome [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Primary outcome [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Primary outcome [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Primary outcome [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Primary outcome [Срок оценки: Six months after completion of oral antibiotic treatment]
Вторичные конечные точки (12)
  • Secondary outcome 1 [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 2 [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 3 [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 4 [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 5 [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 6 [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 7 [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 8 [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 9 [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 10 [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 11 [Срок оценки: Six months after completion of oral antibiotic treatment]
  • Secondary outcome 12 [Срок оценки: Six months after completion of oral antibiotic treatment]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Diagnosed with PVO by a physician based on clinical symptoms and findings consistent with PVO in combination with diagnostic imaging (MRI, PET/CT or PET/MRI)
  • The physician responsible for the patient decides to treat the patient for PVO
  • At time of randomization CRP has decreased to < 75% of peak value or to < 20 mg/l
  • At the time of randomization patient has received maximum 7 days of appropriate IV AB for PVO -

Критерии исключения

  • Previous episodes of PVO within the past 24 months
  • Spinal implants inserted prior to current episode of PVO
  • Hypersensitivity to an AB intended for use in the patient and no alternative drugs available.
  • Oral ABs not possible due to suspicion of reduced absorption
  • Oral Abs not possible due to verified or expected bacterial susceptibility or due to expected toxicity of available regimen
  • Identification of fungus, mold, TB, Brucella, Actinomyces, Nocardia and P. aeruginosa as etiology
  • Severe immunocompromise defined as primary immunodeficiencies, uncontrolled HIV/AIDS, organ transplant recipients, hematological malignancies, patients undergoing biological therapy or chemotherapy and patients treated with prednisolone >=20 mg daily >14 days
  • Verified or expected reduced compliance (for example iv drug use)
  • Pregnancy
  • Breastfeeding
  • Women of childbearing potential, who at the time of inclusion are not using and/or who will not use an effective anticonception method during the treatment period.
  • Patients not capable of providing informed consent at time of screening for inclusion
  • Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization -

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 1 центр
  • Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark — Copenhagen

Идентификаторы

NCT: NCT06250023 · 2023-507617-96-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗