Sickle Cell Disease (SCD)DREPIBACNCT07639008
Epidemiology of Invasive Bacterial Infections in Children With Sickle Cell Disease in France Between 2020 and 2025
An observational study of Sickle Cell Disease (SCD) and Invasive Bacterial Infections, run by Assistance Publique - Hôpitaux de Paris at 31 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Sickle Cell Disease (SCD), Invasive Bacterial Infections
- How many people
- 350 participants
- Where
- 31 sitesFrance
- Study dates
- 15 Jul 2026to 15 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with sickle cell disease followed in participating French hospital centers
Who may be able to join
- 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
Who cannot join
- Opposition from the child or his/her parents
- Bacterium identified by serology
- Urinary tract infection
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
France31 sites
Hôpital Victor Dupouy (CH Argenteuil)
Argenteuil
Samia Pichard
CHI Robert Ballanger
Aulnay-sous-Bois
Yacine Laoudi
Hôpital Jean Verdier
Bondy
Lahoueri Amor Chelihi
Hôpital Pellegrin - Hôpital des Enfants
Bordeaux
Olivier Richer
Hôpital Ambroise Paré
Boulogne-Billancourt
Alice Pascault
Hôpital Saint Camille
Bry-sur-Marne
Laetitia Tourteau
Hôpital NOVO
Cergy-Pontoise
Letitia Pantalone
Hôpital Antoine Béclère
Clamart
Vincent Gajdos
CH Sud Francilien
Corbeil-Essonnes
Cécile Guillaumat
CHI Créteil
Créteil
Cecile Arnaud
CH du Sud Seine et Marne
Fontainebleau
Ioana Wiser
CH Gonesse
Gonesse
Ossam Elias
GHEF, Site de Marne-la-Vallée
Jossigny
Nathalie Garrec
Hôpital Bicêtre
Le Kremlin-Bicêtre
Corinne Guitton
GHT Yvelines Nord
Mantes-la-Jolie
Béatrice Pellegrino
Hôpital Nord, AP-HM
Marseille
Philippe Minodier
GHEF, Site de Meaux
Meaux
Olivier Vignaud
GH Sud Ile-de-france
Melun
Marcel Ilunga Muamba
GHI Le Raincy-Montfermeil
Montfermeil
Tarek Khaled
CHU Nantes
Nantes
Elise Launay
CH Rives de Seine, Site de Neuilly-sur-Seine
Neuilly-sur-Seine
Nathalie Blot
CHU Lenval
Nice
Herve Haas
Hôpital Paris-Saclay
Orsay
Jean Gaschignard
Hôpital Necker
Paris
Slimane Allali
Hôpital Robert Debré
Paris
Bérengère Koehl
Hôpital Trousseau
Paris
Marie Hélène Odièvre-Montaine
CHI Poissy
Poissy
Isabelle Badier
CH Rambouillet
Rambouillet
Stéphanie Muller
CH Saint Denis, Hôpital Delafontaine
Saint-Denis
Alexis Mandelcwajg
Hôpital André Mignot
Versailles
Sylvie Nathanson
Hôpital Intercommunal Villeneuve-St-Georges
Villeneuve-Saint-Georges
Anaïs Chosidow
About this study
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.
Read the 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.
- Keywords
- Sickle cell disease, Pneumococcal conjugate vaccines, Streptococcus pneumoniae, Invasive bacterial infection, Children
- Medical subject headings
- Anemia, Sickle Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Comparison of clinical characteristics of children according to the main bacterial pathogens
Measured: 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
Distribution of S. pneumoniae serotypes and proportion of serotypes covered by PCV15, PCV20 and PCV21 vaccines
Measured: 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
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
Measured: From January 1, 2020 to December 31, 2025
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
Measured: From January 1, 2020 to December 31, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell Disease (SCD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639008
- Sponsor's protocol ID
- APHP260380
- Acronym
- DREPIBAC
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Invasive Bacterial Infections in Children With Sickle Cell Disease in France Between 2020 and 2025
- ClinicalTrials.gov ID
- NCT07639008
- Acronym / sponsor ID
- DREPIBAC / APHP260380
- Keywords
- Sickle cell disease, Pneumococcal conjugate vaccines, Streptococcus pneumoniae, Invasive bacterial infection, Children
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with sickle cell disease followed in participating French hospital centers
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Opposition from the child or his/her parents
- Bacterium identified by serology
- Urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
4 secondary outcomes
To establish correlations between the identified bacteria and the children's clinical characteristics
Time frame: 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
Time frame: 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
Time frame: From January 1, 2020 to December 31, 2025
To estimate the incidence of IBIs in children with sickle cell disease in France
Time frame: From January 1, 2020 to December 31, 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease (SCD) and Invasive Bacterial Infections, run by Assistance Publique - Hôpitaux de Paris at 31 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Gaschignard (+33 (0)1 69 18 03 92, j.gaschignard@ghne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: During the invasive bacterial infection episode occurring between January 1, 2020 and December 31, 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.