Набор скоро начнётся NCT07639008

Epidemiology of Invasive Bacterial Infections in Children With Sickle Cell Disease in France Between 2020 and 2025

— Наблюдательное Sickle Cell Disease (SCD) Invasive Bacterial Infections

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Sickle Cell Disease (SCD), Invasive Bacterial Infections. Базовые параметры: до 17 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: 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

Children with sickle cell disease are at high risk of invasive bacterial infections, which may lead to serious complications. Preventive measures, including antibiotic prophylaxis and vaccination, have changed the epidemiology of these infections over time. New pneumococcal conjugate vaccines have recently become available, and updated data are needed to better understand which bacteria are currently responsible for invasive infections in this population. The aim of this retrospective study is to describe the bacterial distribution of invasive bacterial infections in children with sickle cell disease in France between 2020 and 2025. The results may help improve knowledge of these infections and guide future prevention strategies, including antibiotic management and vaccination policies.

Подробное описание

DREPIBAC is a retrospective, multicenter observational study conducted in French hospital centers following children with sickle cell disease. The study focuses on invasive bacterial infections occurring between January 1, 2020 and December 31, 2025.

Children with sickle cell disease are particularly vulnerable to invasive bacterial infections, especially infections caused by Streptococcus pneumoniae. Over the past decades, antibiotic prophylaxis and vaccination against Haemophilus influenzae type b and Streptococcus pneumoniae have modified the epidemiology of these infections. Previous European data suggested changes in the distribution of bacterial pathogens responsible for invasive bacterial infections in this population. In addition, the recent availability of new pneumococcal conjugate vaccines highlights the need for updated epidemiological data in France.

The primary objective of the study is to establish the bacterial distribution of invasive bacterial infections in children with sickle cell disease in France between 2020 and 2025. Secondary objectives include assessing correlations between the identified bacteria and children's clinical characteristics, evaluating the theoretical coverage of pneumococcal conjugate vaccines against Streptococcus pneumoniae serotypes responsible for invasive infections, and estimating the incidence of invasive bacterial infections in this population.

Data will be collected retrospectively from hospital medical records and entered into a secure REDCap electronic case report form by investigators from participating centers. Collected data will include demographic and clinical characteristics, sickle cell disease phenotype, vaccination status, infection characteristics, microbiological findings, laboratory data, treatment, hospitalization course, and outcomes. Data will be pseudonymized using a unique study code.

The expected sample size is approximately 300 children. Descriptive analyses will be performed to estimate the proportions of the different bacterial pathogens. Standard statistical methods will be used for categorical and continuous variables, and incidence calculations will be performed where appropriate.

Первичные конечные точки

To establish the bacterial distribution of invasive infections in children with sickle cell disease in France (bacteremia, meningitis, osteoarticular or pleural infections) between 2020 and 2025 [Срок оценки: During the invasive bacterial infection episode occurring between January 1, 2020 and December 31, 2025]

Вторичные конечные точки (4)

To establish correlations between the identified bacteria and the children's clinical characteristics [Срок оценки: During the invasive bacterial infection episode occurring between January 1, 2020 and December 31, 2025]
To assess the theoretical coverage of PCV13, PCV15 and PCV20 vaccines against the serotypes of S. pneumoniae strains responsible for invasive infections [Срок оценки: During the invasive bacterial infection episode occurring between January 1, 2020 and December 31, 2025]
To calculate the incidence of IBIs in febrile children with sickle cell disease in the subgroup of centres able to provide the number of patient-years over this period [Срок оценки: From January 1, 2020 to December 31, 2025]
To estimate the incidence of IBIs in children with sickle cell disease in France [Срок оценки: From January 1, 2020 to December 31, 2025]

Критерии участия

Критерии включения

Children with sickle cell disease aged under 18 years
Hospitalized between January 2020 and December 2025
Hospitalized for an invasive bacterial infection clinically defined as meningitis, pleuropneumonia, osteoarticular infection, or primary bacteremia
Bacterium identified by culture or PCR