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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Opposition from the child or his/her parents

Bacterium identified by serology

Urinary tract infection

Trial population

Children with sickle cell disease followed in participating French hospital centers

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

1

To establish correlations between the identified bacteria and the children's clinical characteristics

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
2

To assess the theoretical coverage of PCV13, PCV15 and PCV20 vaccines against the serotypes of S. pneumoniae strains responsible for invasive infections

Distribution of S. pneumoniae serotypes and proportion of serotypes covered by PCV15, PCV20 and PCV21 vaccines

Time frame
During the invasive bacterial infection episode occurring between January 1, 2020 and December 31, 2025
3

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

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
4

To estimate the incidence of IBIs in children with sickle cell disease in France

Incidence of IBIs in children with sickle cell disease in France

Time frame
From January 1, 2020 to December 31, 2025

Other outcomes

Sponsors and contacts

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