Sickle Cell DiseaseNCT07037706
Use of Macrolides in Acute Chest Syndrome: A Multicenter Retrospective Study
An observational study of Sickle Cell Disease and Acute Chest Syndrome, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
This study looks at whether using macrolide antibiotics is helpful and safe in treating acute chest syndrome, a serious complication in people with sickle cell disease. It reviews past cases from three hospitals where patients were treated in intensive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease, Acute Chest Syndrome, Glucose-6-Phosphate Dehydrogenase Deficiency
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 1 Jun 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population consists of adult patients (aged 18 and older) with sickle cell disease who were diagnosed with acute chest syndrome (ACS) and required hospitalization in an intensive care unit (ICU). All selected patients must have received an empiric antibiotic treatment including a macrolide and undergone microbiological sampling (such as PCR multiplex, sputum culture, or urinary antigen testing for Legionella). Participants will be identified retrospectively from medical records across the three participating hospital centers over the study period.
Who may be able to join
- Adult patient (≥18 years old).
- Diagnosis of acute chest syndrome (ACS).
- Hospitalized in an intensive care unit (ICU).
- Microbiological sampling performed (e.g., multiplex PCR, sputum culture [ECBC], and/or Legionella urinary antigen test).
- Received empiric antibiotic therapy including a macrolide.
Who cannot join
- Minor patient (<18 years old).
- Acute chest syndrome not requiring ICU admission.
- Acute chest syndrome without any attempt at microbiological documentation.
Trial locations and contacts
1 site in 1 country.
About this study
This study looks at whether using macrolide antibiotics is helpful and safe in treating acute chest syndrome, a serious complication in people with sickle cell disease. It reviews past cases from three hospitals where patients were treated in intensive care. The goal is to understand if macrolides make a difference, what germs are involved, how useful lab tests are, and how well patients tolerate these antibiotics.
- Conditions
- Sickle Cell Disease, Acute Chest Syndrome, Glucose-6-Phosphate Dehydrogenase Deficiency, Anti-Bacterial Agents, Macrolides
- Medical subject headings
- Anemia, Sickle Cell, Acute Chest Syndrome, Glucosephosphate Dehydrogenase Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation (in days) among patients with ACS treated with empiric macrolides
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037706
- Sponsor's protocol ID
- 0063_REANIMATION
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 25 Jun 2025
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Macrolides in Acute Chest Syndrome: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT07037706
- Acronym / sponsor ID
- 0063_REANIMATION
- Conditions
- Sickle Cell Disease, Acute Chest Syndrome, Glucose-6-Phosphate Dehydrogenase Deficiency, Anti-Bacterial Agents, Macrolides
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 25 Jun 2025 (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.
This study looks at whether using macrolide antibiotics is helpful and safe in treating acute chest syndrome, a serious complication in people with sickle cell disease. It reviews past cases from three hospitals where patients were treated in intensive care. The goal is to understand if macrolides make a difference, what germs are involved, how useful lab tests are, and how well patients tolerate these antibiotics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 and older) with sickle cell disease who were diagnosed with acute chest syndrome (ACS) and required hospitalization in an intensive care unit (ICU). All selected patients must have received an empiric antibiotic treatment including a macrolide and undergone microbiological sampling (such as PCR multiplex, sputum culture, or urinary antigen testing for Legionella). Participants will be identified retrospectively from medical records across the three participating hospital centers over the study period.
Key inclusion criteria (5 listed)
- Adult patient (≥18 years old).
- Diagnosis of acute chest syndrome (ACS).
- Hospitalized in an intensive care unit (ICU).
- Microbiological sampling performed (e.g., multiplex PCR, sputum culture [ECBC], and/or Legionella urinary antigen test).
- Received empiric antibiotic therapy including a macrolide.
Key exclusion criteria (3 listed)
- Minor patient (<18 years old).
- Acute chest syndrome not requiring ICU admission.
- Acute chest syndrome without any attempt at microbiological documentation.
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
Duration of mechanical ventilation (in days) among patients with ACS treated with empiric macrolides
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and Acute Chest Syndrome, run by Centre Hospitalier de Saint-Denis at 1 site 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 5 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: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation (in days) among patients with ACS treated with empiric macrolides (time frame: 28 days). 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 25 Jun 2025.