An interventional study of Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin and Control: usual antibiotic treatment in Acute Chest Syndrome and Sickle Cell Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
Many patients with Sickle Cell Disease (SCD) may develop Acute Chest Syndrome (ACS). ACS is usually caused by a Lower respiratory tract infection (LRTI) which may be caused by either a bacterium or a virus. Antibiotics are usually used for 7 to 10 days with no microbiological workup.
The hypothesis of the study is that the identification of the microorganisms might lead to a reduction of antibiotics exposure and a better care of the patients.
We speculate that an early pathogen-directed strategy (respiratory broad panel multiplex PCR and early antibiotics interruption based on the PCT values decrease) might reduce the antibiotics exposure in SCD patients with ACS who are hospitalized and for whom an antibiotic treatment is indicated, as compared with usual care
Acute Chest Syndrome (ACS) is a frequent and severe acute complication of sickle-cell disease. It may affect 10 to 20% of hospitalized patients and is the leading cause of death. The symptoms combine a new pulmonary infiltrate and symptom(s) among fever, cough, dyspnea, expectoration, chest pain and crackles. The pathophysiology of ACS is complex and there are many interlinked aetiologies.
Lower respiratory tract infection (LRTI) is one of the most frequent aetiologies of ACS. Intracellular bacteria (Chlamydia, Mycoplasma), respiratory virus (especially respiratory syncytial virus) and pyogenes (Streptococcus pneumoniae and Staphylococcus aureus) are the most frequently identified microorganisms. Nevertheless, the clinical presentation of ACS is not helpful for the diagnosis of LRTI; the respiratory tract samples are not always collected, either because the patients do not expectorate or because the benefit-risk ratio of a fiberoptic bronchoscopy may be not advantageous. Moreover, usual diagnostic test are not enough performant.
The current practices rely on the systematic administration of antibiotics for 7 to 10 days. The efficacy and safety of alternative diagnostic and therapeutic strategies have never been evaluated in controlled clinical trial to cure ACS.
In this context, the optimisation of the microbiological documentation of ACS might enhance the use of antimicrobial drugs, reduce their duration, and limit the emergence of multidrug resistant bacteria.
Therefore, we speculate that an early pathogen-directed strategy (respiratory broad panel multiplex PCR and early antibiotics interruption based on the PCT values decrease) might reduce the antibiotics exposure in SCD patients with ACS who are hospitalized and for whom an antibiotic treatment is indicated, as compared with usual care.
37 studies on the registry are indexed under Acute Chest Syndrome; 11 are open to participants now.
This study's enrollment of 72 is above the median of 63 across 26 interventional studies indexed under Acute Chest Syndrome.
Browse Acute Chest Syndrome studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.
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Exclusion Criteria:
Documented extra-pulmonary bacterial infection at the time of inclusion;
usual antibiotic treatment
Procedure: Control: usual antibiotic treatment
targeted antibiotic treatment according to the results of PCR multiplex
Procedure: Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin
The actions or procedures added by the research are the realization of a nasopharyngeal swab in the two strategies, and the PCT assay at D1, D3 and D7 in the pathogen-directed strategy
usual antibiotic treatment
to compare the antibiotics exposure at 28 days (D28) after the diagnosis of ACS between the two strategies
Time frame: Day 28
Rate of microbiological documentation of ACS
Time frame: Day 28
Transfer to ICU at 28 days (D28) after the diagnosis of ACS between the two strategies
Time frame: Day 28
Survival at 28 days
Time frame: Day 28
occurrence of a secondary bacterial respiratory infection or any other secondary infection at 28 days
Time frame: Day 28
Global use of antibiotics at 28 days
Time frame: Day 28
Time to clinical stability at 28 days
Time frame: Day 28
transfusion and exchange transfusion at 28 days
Time frame: Day 28
ICU and hospital lengths of stay
Time frame: Day 28
Readmission rate in hospital at 28 days
Time frame: Day 28
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris