Current partner codePEPTIDESDE
NCT03919266·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

72

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Full 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

Treatment arms and agents.

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

PROCEDURE

Control: usual antibiotic treatment

usual antibiotic treatment

Timeline

From registration to results.

  1. First posted

    Apr 18, 2019

  2. Study start

    Jun 2, 2020

  3. Primary completion

    Oct 10, 2022

  4. Study completion

    Oct 10, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Mar 24, 2025

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Day 28

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

1 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

Service de Réanimation et USC médico-chirurgicale

Paris, France

Related trials

More studies on Calcitonin.

Related PeptideStat pages

Put the record in context.

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