CPAP for Hypoxemic Acute Chest Syndrome in Sickle Cell Disease
NCT07703566
Acute Chest Syndrome, Acute Chest Syndrome (ACS)
View Trial DetailsNCT Number: NCT07639008
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.
Trial opening soon.
Get NotifiedUp to 17 year
All sexes
Observational
Hôpital Victor Dupouy (CH Argenteuil), Argenteuil, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From January 1, 2020 to December 31, 2025
Incidence of IBIs in children with sickle cell disease in France
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: DREPIBAC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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