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Идёт набор NCT06322290

Epidemiological Study on Invasive Bacterial Diseases

Наблюдательное Invasive Bacterial Diseases (IBD)

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: assessment of pathogens in blood specimens.
Кому может быть актуально
Состояния в реестре: Invasive Bacterial Diseases (IBD). Базовые параметры: 1 Day — 70 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Epidemiological Study on Invasive Bacterial Diseases (IBD)

Обзор

Streptococcus pneumoniae (pneumococcus), Neisseria meningitidis (meningococcus), and Haemophilus influenzae (hemophilus) are among the main bacteria responsible for invasive bacterial diseases (MBIs) that result in severe clinical pictures also characterized by a high frequency of serious complications. Surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiologic trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.The present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies.

Подробное описание

Pathogen identification by culture methods has been shown to be unsatisfactory, as antibiotic therapy carried out in patients before hospitalization prevents bacterial culture development and subsequent typing in many cases. In addition, technical problems due to sample collection, storage and transport reduce germ viability leading to false negatives in pathogen identification by culture methods. In contrast, molecular diagnosis allows germ identification on biological samples even in the absence of germ viability, thus enabling more accurate diagnosis.

Surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiological trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.In 2006, the AOU Meyer Immunology Laboratory received a grant from the National Center for Disease Prevention and Control (NCDC) to develop a molecular diagnostic method for surveillance of invasive infections with Neisseria meningitidis (meningococcal,) Streptococcus pneumoniae (pneumococcus) and Haemophilus influenzae (hemophilus) that would allow identification of the germ on biological samples even in the absence of germ viability, with a view to improving surveillance, prevention and treatment strategies. The project involved performing molecular diagnostic tests on samples from patients referred to hospitals in the Tuscany Region and outside the region. The present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies.

Вмешательства

  • Диагностический тест assessment of pathogens in blood specimens
    Molecular diagnosis of Invasive bacterial diseases due to Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae

Первичные конечные точки

  • Incidence rate of Infective Bacterial Diseases from Streptococcus pneumoniae (pneumococcus) during the study period in pediatric age. [Срок оценки: Through study completion, an average of 1 year]
  • Incidence rate of of Infective Bacterial Diseases cases from Neisseria meningitidis during the study period in pediatric age. [Срок оценки: Through study completion, an average of 1 year]
  • Incidence rate of Infective Bacterial Diseases cases from Haemophilus influenzae during the study period in pediatric age. [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (3)
  • Frequency of circulating serogroups/serotypes in Italy for S.pneumoniae, N.meningitidis, H.influenzae. [Срок оценки: Through study completion, an average of 1 year]
  • Proportion of these invasive infections (S.pneumoniae, N.meningitidis, H.influenzae) that are preventable by vaccine in Italy [Срок оценки: Through study completion, an average of 1 yeary]
  • Vaccine failure rate for S.pneumoniae, N.meningitidis, and H.influenzae. [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus MBI

Критерии исключения

  • Other type of bacterial infections.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 38 центров
  • Ospedale di Adria — Adria
  • Ospedali riuniti di Ancona — Ancona
  • Ospedale di Andria — Andria
  • Ospedale Giovanni XXIII — Bari
  • Policlinico S.Orsola-Malpighi IRCCS — Bologna
  • Fondazione poliambulanza Brescia — Brescia
  • Ospedale Giovanni XXIII — Brescia
  • Ospedale di Campobasso — Campobasso
  • … и ещё 30 центров

Идентификаторы

NCT: NCT06322290 · SEMBAI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗