Invasive Bacterial Infections, Sickle Cell Disease (SCD)
Conditions
Keywords
Sickle cell disease, Pneumococcal conjugate vaccines, Streptococcus pneumoniae, Invasive bacterial infection, Children
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Opposition from the child or his/her parents * Bacterium identified by serology * Urinary tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | During the invasive bacterial infection episode occurring between January 1, 2020 and December 31, 2025 | Proportion of the different bacteria involved in IBIs in children with sickle cell disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To establish correlations between the identified bacteria and the children's clinical characteristics | During the invasive bacterial infection episode occurring between January 1, 2020 and December 31, 2025 | Comparison of clinical characteristics of children according to the main bacterial pathogens |
| To assess the theoretical coverage of PCV13, PCV15 and PCV20 vaccines against the serotypes of S. pneumoniae strains responsible for invasive infections | During the invasive bacterial infection episode occurring between January 1, 2020 and December 31, 2025 | Distribution of S. pneumoniae serotypes and proportion of serotypes covered by PCV15, PCV20 and PCV21 vaccines |
| 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 | From January 1, 2020 to December 31, 2025 | 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 |
| To estimate the incidence of IBIs in children with sickle cell disease in France | From January 1, 2020 to December 31, 2025 | Incidence of IBIs in children with sickle cell disease in France |
Countries
France
Contacts
CONTACTJean Gaschignard
Outcome results
None listed