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

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.