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Идёт набор NCT06899906

Efficacy and Safety of Dalbavancin As Suppressive Therapy

— Наблюдательное Efficacy and Safety of Dalbavancin In Subjects Who Received SAT with DAL For Acute or Chronic Infections Between July 2019 and December 2024

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: Determine patient demographic and clinical characteristics at baseline.
Кому может быть актуально
Состояния в реестре: Efficacy and Safety of Dalbavancin, In Subjects Who Received SAT with DAL, For Acute or Chronic Infections Between July 2019 and December 2024. Базовые параметры: Без ограничений · 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Dalbavancin (DAL) is a semi-synthetic antibiotic that belongs to the lipoglycopeptide family and is structurally derived from teicoplanin, respect of which it has two structural differences that enhance its anti-staphylococcal binding affinity and extend its half-life to between 149 and 250 hours. It achieves adequate tissue penetration in the skin, bones, joints, lung tissues, and peritoneal space, maintaining concentrations above the MIC for susceptible Gram-positive pathogen. DAL is a bactericidal antimicrobial agent that binds the C-terminal D-alanyl-D-alanine on the bacterial cell wall, blocking trans-glycosylation and transpeptidation processes essential for cell wall synthesis. It seems also to be able to enhance neutrophil antibacterial activity improving PMNs' intracellular killing of MRSA. It has also a good antibiofilm activity, alone or in combination with other molecules. Like other glycopeptide molecules, DAL shares a similar spectrum of activity, with demonstrated in vitro activity against various Gram-positive bacteria, including Staphylococcus spp, Streptococcus spp and Enterococcus (faecium, and faecalis). Resistance to DAL is possible in these gram-positives bacteria, given to presence of enzymes that produce low-affinity binding precursors for the antibiotic's binding site. DAL is capable to overcome Van-B mechanism of resistance, but it results not active in producing Van-A strains. The study objectives was to evaluate efficacy and safety of DAL treatment.

Вмешательства

  • Другое Determine patient demographic and clinical characteristics at baseline
    Description of demographic data (sex, age), comorbidities (Charlson scores), septic history, and medical management (antibiotic therapy)

Первичные конечные точки

  • efficacy of DAL treatment, measured as the proportion of stable infection [Срок оценки: Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis .]

Критерии участия

Критерии включения

  • > 18 years
  • Patients received SAT with DAL for acute or chronic infections (defined as a long-standing infection due to a previously uneradicated pathogen, following unsuccessful antibiotic or surgical treatments) between July 2019 and December 2024
  • Patient who was informed and did not object to participating in the study

Критерии исключения

  • -< 18 years
  • Subjects who received DAL not for SAT purposes

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • HCL — France

Идентификаторы

NCT: NCT06899906 · 25-5019

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗