NCT07037706

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 11, 2025

Last Update Submit

June 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Duration of mechanical ventilation (in days) among patients with ACS treated with empiric macrolides

    28 days

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Minor patient (\<18 years old).
  • Acute chest syndrome not requiring ICU admission.
  • Acute chest syndrome without any attempt at microbiological documentation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France

Saint-Denis, France, France

Location

MeSH Terms

Conditions

Anemia, Sickle CellAcute Chest SyndromeGlucosephosphate Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLung DiseasesRespiratory Tract DiseasesRespiration DisordersCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 25, 2025

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations