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Combined Use of a Respiratory Broad Panel Multiplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Hospitalized Sickle-cell Adults With Acute Chest Syndrome.

Combined Use of a Respiratory Broad Panel Multiplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Adult Patients With Sickle-cell Disease Hospitalized for Acute Chest Syndrome. A Bi-centric, Open, Parallel-group, Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03919266
Acronym
Antibio_STA
Enrollment
72
Registered
2019-04-18
Start date
2020-06-02
Completion date
2022-10-10
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Chest Syndrome, Sickle Cell Disease

Keywords

Acute chest syndrome, SCD, PCR multiplex, antibiotic treatment

Brief summary

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

Detailed description

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.

Interventions

PROCEDUREIntervention: 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

PROCEDUREControl: usual antibiotic treatment

usual antibiotic treatment

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Sickle Cell Disease patients with ACS with an antibiotic therapy indication * Signed and informed consent * Affiliated with social security

Exclusion criteria

Documented extra-pulmonary bacterial infection at the time of inclusion; * Patients who received antibiotics for more than 24 hours before the diagnosis of ACS (during the primary hospitalization) * Known severe immunosuppression (AIDS, neutropenia (\<1000 PNN), hematology, solid tumor under chemotherapy, transplanted organ); long-term treatment with hydroxy-carbamide is not considered * Pregnant or lactating women; * Person deprived of liberty or under legal protection; * Participation in another interventional study of type Jardé 1

Design outcomes

Primary

MeasureTime frame
to compare the antibiotics exposure at 28 days (D28) after the diagnosis of ACS between the two strategiesDay 28

Secondary

MeasureTime frame
Transfer to ICU at 28 days (D28) after the diagnosis of ACS between the two strategiesDay 28
Survival at 28 daysDay 28
occurrence of a secondary bacterial respiratory infection or any other secondary infection at 28 daysDay 28
Global use of antibiotics at 28 daysDay 28
Rate of microbiological documentation of ACSDay 28
transfusion and exchange transfusion at 28 daysDay 28
ICU and hospital lengths of stayDay 28
Readmission rate in hospital at 28 daysDay 28
Time to clinical stability at 28 daysDay 28

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026