NCT07639008

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

31 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2027

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 5, 2026

Last Update Submit

June 5, 2026

Conditions

Keywords

Sickle cell diseasePneumococcal conjugate vaccinesStreptococcus pneumoniaeInvasive bacterial infectionChildren

Outcome Measures

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

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

Secondary Outcomes (4)

  • 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

  • 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

  • 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

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

    From January 1, 2020 to December 31, 2025

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with sickle cell disease followed in participating French hospital centers

You may qualify if:

  • 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

You may not qualify if:

  • Opposition from the child or his/her parents
  • Bacterium identified by serology
  • Urinary tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Hôpital Victor Dupouy (CH Argenteuil)

Argenteuil, France

Location

CHI Robert Ballanger

Aulnay-sous-Bois, France

Location

Hôpital Jean Verdier

Bondy, France

Location

Hôpital Pellegrin - Hôpital des Enfants

Bordeaux, France

Location

Hôpital Ambroise Paré

Boulogne-Billancourt, France

Location

Hôpital Saint Camille

Bry-sur-Marne, France

Location

Hôpital NOVO

Cergy-Pontoise, France

Location

Hôpital Antoine Béclère

Clamart, France

Location

CH Sud Francilien

Corbeil-Essonnes, France

Location

CHI Créteil

Créteil, France

Location

CH du Sud Seine et Marne

Fontainebleau, France

Location

CH Gonesse

Gonesse, France

Location

GHEF, Site de Marne-la-Vallée

Jossigny, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

GHT Yvelines Nord

Mantes-la-Jolie, France

Location

Hôpital Nord, AP-HM

Marseille, France

Location

GHEF, Site de Meaux

Meaux, France

Location

GH Sud Ile-de-france

Melun, France

Location

GHI Le Raincy-Montfermeil

Montfermeil, France

Location

CHU Nantes

Nantes, France

Location

CH Rives de Seine, Site de Neuilly-sur-Seine

Neuilly-sur-Seine, France

Location

CHU Lenval

Nice, France

Location

Hôpital Paris-Saclay

Orsay, France

Location

Hôpital Necker

Paris, France

Location

Hôpital Robert Debré

Paris, France

Location

Hôpital Trousseau

Paris, France

Location

CHI Poissy

Poissy, France

Location

CH Rambouillet

Rambouillet, France

Location

CH Saint Denis, Hôpital Delafontaine

Saint-Denis, France

Location

Hôpital André Mignot

Versailles, France

Location

Hôpital Intercommunal Villeneuve-St-Georges

Villeneuve-Saint-Georges, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 10, 2026

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

July 15, 2027

Last Updated

June 10, 2026

Record last verified: 2026-06

Locations