Sickle Cell DiseaseDREPANO-BACTNCT05197205
Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
A study testing nasopharyngeal swabbing in people with Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The objective of this study is to to determine the rate of nasopharyngeal carriage of Streptococcus pneumoniae (Sp) in children with sickle cell disease over 6 months and under 15 years of age over a 9-month period in Ile-De-France. Read more about this study
- Who is it for?
- Ages 6 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- nasopharyngeal swabbing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 months to 15 years, regardless of immunization status.
- Child with a major sickle cell syndrome (SS, SC, S+, S°, SE) followed in one of the centers of competence or reference for rare diseases (CRMR) " Major sickle cell syndromes, Thalassemias and other rare pathologies of the Red Blood Cell and Erythropoiesis " in Ile de France.
- Children who are not subject to legal protection measures.
- Child affiliated to a social security system.
- Signed informed consent
Who cannot join
- Sickle cell child with a febrile syndrome at the time of sampling or hospitalized for any reason.
- Child having received antibiotic therapy other than oracillin in the 7 days preceding the nasopharyngeal swab.
- Child already included in the observation period (only 1 nasopharyngeal swab per patient).
- Other hemoglobinopathies and heterozygous AS or AC patients.
- Patients already involved in a therapeutic protocol or in the exclusion period following a previous research.
- Patients under AME or without social security coverage.
Trial locations and contacts
No sites are listed yet.
About this study
The objective of this study is to to determine the rate of nasopharyngeal carriage of Streptococcus pneumoniae (Sp) in children with sickle cell disease over 6 months and under 15 years of age over a 9-month period in Ile-De-France.
Read the detailed description
Sickle cell disease is the most common genetic disease in France, with one affected child for every 1,736 births. Ile-de-France is the region in Europe with the highest prevalence of sickle cell disease.
Children with sickle cell disease have an increased susceptibility to infections related to encapsulated bacteria and are at high risk of invasive infections (particularly Streptococcus pneumoniae), which is the leading cause of mortality in children with sickle cell disease under 5 years of age worldwide.
the patients are subject to intense selection pressure (long-term antibiotic prophylaxis and systematic probabilistic curative antibiotic therapy) and are at high risk of carrying nosocomial bacteria (repeated hospitalizations). Moreover, children with sickle cell disease have reinforced immunization schedules, especially against pneumococcal disease.
However, data concerning the carriage of resistant bacteria (prevalence, risk factors) in children with sickle cell disease in France are scarce.
This study aims to determine the nasopharyngeal bacterial carriage and antibiotic resistance in children with sickle cell disease in Ile-De-France
- Conditions
- Sickle Cell Disease
- Being tested
- nasopharyngeal swabbing
- Keywords
- Sickle celle disease, Nasopharyngeal bacterial carriage
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal swabbingProcedure or surgery
A nasopharyngeal swab is collected during the consultation, with bacteriological analysis. No follow-up visit is required for this study
| Study group | Role | What they receive |
|---|---|---|
| sickle cell children group | Experimental | A nasopharyngeal swab is taken during the consultation, with bacteriological analysis. Receives: Procedure: nasopharyngeal swabbing |
| control children group | No intervention | healthy children control group (ACTIV network) |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the proportion of sickle cell children with nasopharyngeal carriage of Streptococcus pneumoniae (Sp) among the total number of sickle cell children screened by nasopharyngeal swab.
the rate of nasopharyngeal carriage of Streptococcus pneumoniae (Sp) in children with sickle cell disease aged over 6 months and under 15 years over a 12-month period in Ile-De-France.
Measured: 12 months
Secondary outcomes (7)
determine the rate of nasopharyngeal carriage of penicillin-deficient pneumococcus (PDSP) in sickle cell children over 6 months and under 15 years of age over a 9-month period in Ile-De-France.
Proportion of sickle cell children with nasopharyngeal carriage of penicillin-deficient pneumococcus (PDSP) among the total number of sickle cell children screened by nasopharyngeal swab.
Measured: 12 months
determine the proportion of vaccine serotypes among pneumococcal strains in children with sickle cell disease aged over 6 months and under 15
Proportion of children with vaccine serotypes among the pneumococcal strains
Measured: 12 months
Determine the proportion of non-vaccine serotypes among all pneumococcal strains in children with sickle cell disease over 6 months and under 15 years of age.
Proportion of non-vaccine serotypes among all pneumococcal strains.
Measured: 12 months
Determine the nasopharyngeal carriage rate of methicillin-resistant Staphylococcus aureus (MRSA), Haemophilus influenzae, Moraxella catarrhalis in children with sickle cell disease over 6 months and under 15 years of age.
Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated from a nasopharyngeal swab).
Measured: 12 months
compare the rate of nasopharyngeal carriage of Streptococcus pneumoniae and PSDP between the sickle cell group and the healthy group of children according to age groups.
Proportion of children with Streptococcus pneumoniae and PSDP (isolated on nasopharyngeal swab) by age group.
Measured: 12 months
Compare the proportion of non-vaccine serotypes among the Streptococcus pneumoniae strains between the sickle cell group and the healthy group of children.
Proportion of non-vaccine serotypes among nasopharyngeal strains of Streptococcus pneumoniae.
Measured: 12 months
compare the nasopharyngeal carriage rate of MRSA, Haemophilus influenzae, Moraxella catarrhalis between the sickle cell group and the healthy children group.
Proportion of children with MRSA, Haemophilus influenzae, Moraxella Catarrhalis (isolated on nasopharyngeal swab).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 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
- NCT05197205
- Sponsor's protocol ID
- APHP211360
- Acronym
- DREPANO-BACT
- Status last verified
- Oct 2021
- First submitted
- 9 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schaumburg F, Biallas B, Ngoune Feugap E, Alabi AS, Mordmuller B, Kremsner PG, Grobusch MP, Lell B, van der Linden M, Peters G, Adegnika AA. Carriage of encapsulated bacteria in Gabonese children with sickle cell anaemia. Clin Microbiol Infect. 2013 Mar;19(3):235-41. doi: 10.1111/j.1469-0691.2012.03771.x. Epub 2012 Feb 13.
PubMed 22329610Dayie NTKD, Tetteh-Ocloo G, Labi AK, Olayemi E, Slotved HC, Lartey M, Donkor ES. Pneumococcal carriage among sickle cell disease patients in Accra, Ghana: Risk factors, serotypes and antibiotic resistance. PLoS One. 2018 Nov 8;13(11):e0206728. doi: 10.1371/journal.pone.0206728. eCollection 2018.
PubMed 30408061Schaumburg F, Biallas B, Alabi AS, Grobusch MP, Feugap EN, Lell B, Mellmann A, Peters G, Kremsner PG, Becker K, Adegnika AA. Clonal structure of Staphylococcus aureus colonizing children with sickle cell anaemia and healthy controls. Epidemiol Infect. 2013 Aug;141(8):1717-20. doi: 10.1017/S0950268812002270. Epub 2012 Oct 10.
PubMed 23050673Pham LL, Varon E, Bonacorsi S, Boubaya M, Benhaim P, Amor-Chelihi L, Houlier M, Koehl B, Missud F, Brousse V, Gajdos V, Bizot E, Briand C, Malka A, Odievre MH, Romain AS, Hau I, Pondarre C, See H, Guitton C, Zenkhri F, Holvoet L, Benkerrou M, Da Silveira C, Belaid N, Laurent O, Vassal M, Basmaci R, Aupiais C, Bloch-Queyrat C, Levy C, Cohen R, Ouldali N, De Pontual L, Carbonnelle E, Gaschignard J. Nasopharyngeal Carriage and Antibiotic Resistance in Children With Sickle Cell Disease: The DREPANOBACT French Multicenter Prospective Study. Pediatr Infect Dis J. 2025 May 1;44(5):387-393. doi: 10.1097/INF.0000000000004744. Epub 2025 Feb 3.
PubMed 40232881
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasopharyngeal Bacterial Carriage and Antibiotic Resistance in Children With Sickle Cell Disease in Ile-De-France
- ClinicalTrials.gov ID
- NCT05197205
- Acronym / sponsor ID
- DREPANO-BACT / APHP211360
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle celle disease, Nasopharyngeal bacterial carriage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 19 Jan 2022 (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.
The objective of this study is to to determine the rate of nasopharyngeal carriage of Streptococcus pneumoniae (Sp) in children with sickle cell disease over 6 months and under 15 years of age over a 9-month period in Ile-De-France.
Detailed description
Sickle cell disease is the most common genetic disease in France, with one affected child for every 1,736 births. Ile-de-France is the region in Europe with the highest prevalence of sickle cell disease.
Children with sickle cell disease have an increased susceptibility to infections related to encapsulated bacteria and are at high risk of invasive infections (particularly Streptococcus pneumoniae), which is the leading cause of mortality in children with sickle cell disease under 5 years of age worldwide.
the patients are subject to intense selection pressure (long-term antibiotic prophylaxis and systematic probabilistic curative antibiotic therapy) and are at high risk of carrying nosocomial bacteria (repeated hospitalizations). Moreover, children with sickle cell disease have reinforced immunization schedules, especially against pneumococcal disease.
However, data concerning the carriage of resistant bacteria (prevalence, risk factors) in children with sickle cell disease in France are scarce.
This study aims to determine the nasopharyngeal bacterial carriage and antibiotic resistance in children with sickle cell disease in Ile-De-France
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sickle cell children group | Experimental | Procedure: nasopharyngeal swabbingA nasopharyngeal swab is taken during the consultation, with bacteriological analysis. |
| control children group | No intervention | –healthy children control group (ACTIV network) |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6 months to 15 years, regardless of immunization status.
- Child with a major sickle cell syndrome (SS, SC, S+, S°, SE) followed in one of the centers of competence or reference for rare diseases (CRMR) " Major sickle cell syndromes, Thalassemias and other rare pathologies of the Red Blood Cell and Erythropoiesis " in Ile de France.
- Children who are not subject to legal protection measures.
- Child affiliated to a social security system.
- Signed informed consent
Key exclusion criteria (6 listed)
- Sickle cell child with a febrile syndrome at the time of sampling or hospitalized for any reason.
- Child having received antibiotic therapy other than oracillin in the 7 days preceding the nasopharyngeal swab.
- Child already included in the observation period (only 1 nasopharyngeal swab per patient).
- Other hemoglobinopathies and heterozygous AS or AC patients.
- Patients already involved in a therapeutic protocol or in the exclusion period following a previous research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasopharyngeal swabbingA nasopharyngeal swab is collected during the consultation, with bacteriological analysis. No follow-up visit is required for this study | Procedure or surgery | sickle cell children group |
Primary outcome
determine the proportion of sickle cell children with nasopharyngeal carriage of Streptococcus pneumoniae (Sp) among the total number of sickle cell children screened by nasopharyngeal swab.
Time frame: 12 months
the rate of nasopharyngeal carriage of Streptococcus pneumoniae (Sp) in children with sickle cell disease aged over 6 months and under 15 years over a 12-month period in Ile-De-France.
7 secondary outcomes
determine the rate of nasopharyngeal carriage of penicillin-deficient pneumococcus (PDSP) in sickle cell children over 6 months and under 15 years of age over a 9-month period in Ile-De-France.
Time frame: 12 months
determine the proportion of vaccine serotypes among pneumococcal strains in children with sickle cell disease aged over 6 months and under 15
Time frame: 12 months
Determine the proportion of non-vaccine serotypes among all pneumococcal strains in children with sickle cell disease over 6 months and under 15 years of age.
Time frame: 12 months
Determine the nasopharyngeal carriage rate of methicillin-resistant Staphylococcus aureus (MRSA), Haemophilus influenzae, Moraxella catarrhalis in children with sickle cell disease over 6 months and under 15 years of age.
Time frame: 12 months
compare the rate of nasopharyngeal carriage of Streptococcus pneumoniae and PSDP between the sickle cell group and the healthy group of children according to age groups.
Time frame: 12 months
Compare the proportion of non-vaccine serotypes among the Streptococcus pneumoniae strains between the sickle cell group and the healthy group of children.
Time frame: 12 months
compare the nasopharyngeal carriage rate of MRSA, Haemophilus influenzae, Moraxella catarrhalis between the sickle cell group and the healthy children group.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Background: PubMed 22329610Schaumburg F, Biallas B, Ngoune Feugap E, Alabi AS, Mordmuller B, Kremsner PG, Grobusch MP, Lell B, van der Linden M, Peters G, Adegnika AA. Carriage of encapsulated bacteria in Gabonese children with sickle cell anaemia. Clin Microbiol Infect. 2013 Mar;19(3):235-41. doi: 10.1111/j.1469-0691.2012.03771.x. Epub 2012 Feb 13.
- Background: PubMed 30408061Dayie NTKD, Tetteh-Ocloo G, Labi AK, Olayemi E, Slotved HC, Lartey M, Donkor ES. Pneumococcal carriage among sickle cell disease patients in Accra, Ghana: Risk factors, serotypes and antibiotic resistance. PLoS One. 2018 Nov 8;13(11):e0206728. doi: 10.1371/journal.pone.0206728. eCollection 2018.
- Background: PubMed 23050673Schaumburg F, Biallas B, Alabi AS, Grobusch MP, Feugap EN, Lell B, Mellmann A, Peters G, Kremsner PG, Becker K, Adegnika AA. Clonal structure of Staphylococcus aureus colonizing children with sickle cell anaemia and healthy controls. Epidemiol Infect. 2013 Aug;141(8):1717-20. doi: 10.1017/S0950268812002270. Epub 2012 Oct 10.
- Derived from this study: PubMed 40232881Pham LL, Varon E, Bonacorsi S, Boubaya M, Benhaim P, Amor-Chelihi L, Houlier M, Koehl B, Missud F, Brousse V, Gajdos V, Bizot E, Briand C, Malka A, Odievre MH, Romain AS, Hau I, Pondarre C, See H, Guitton C, Zenkhri F, Holvoet L, Benkerrou M, Da Silveira C, Belaid N, Laurent O, Vassal M, Basmaci R, Aupiais C, Bloch-Queyrat C, Levy C, Cohen R, Ouldali N, De Pontual L, Carbonnelle E, Gaschignard J. Nasopharyngeal Carriage and Antibiotic Resistance in Children With Sickle Cell Disease: The DREPANOBACT French Multicenter Prospective Study. Pediatr Infect Dis J. 2025 May 1;44(5):387-393. doi: 10.1097/INF.0000000000004744. Epub 2025 Feb 3.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing nasopharyngeal swabbing in people with Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luu-Ly PHAM (0148024405, luu-ly.pham@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine the proportion of sickle cell children with nasopharyngeal carriage of Streptococcus pneumoniae (Sp) among the total number of sickle cell children screened by nasopharyngeal swab. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05197205, which also lists 4 linked publications.
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 19 Jan 2022.