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

NCT03919266 | Completed

• 1 other identifier: APHP180159
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Chest Syndrome; Sickle Cell Disease

Keywords

Acute chest syndrome; SCD; PCR multiplex; antibiotic treatment

Outcome Measures

Primary Outcomes (1)

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

  Day 28

Secondary Outcomes (9)

• Rate of microbiological documentation of ACS

  Day 28

• Transfer to ICU at 28 days (D28) after the diagnosis of ACS between the two strategies

  Day 28

• Survival at 28 days

  Day 28

• occurrence of a secondary bacterial respiratory infection or any other secondary infection at 28 days

  Day 28

• Global use of antibiotics at 28 days

  Day 28

Study Arms (2)

Control

OTHER

usual antibiotic treatment

Procedure: Control: usual antibiotic treatment

Intervention

EXPERIMENTAL

targeted antibiotic treatment according to the results of PCR multiplex

Procedure: Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin

Interventions

Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin PROCEDURE

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

Intervention

Control: usual antibiotic treatment PROCEDURE

usual antibiotic treatment

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Réanimation et USC médico-chirurgicale

Paris, 75020, France

Location

Related Publications (1)

• Sabate-Elabbadi A, Mekontso-Dessap A, Lionnet F, Santin A, Verdet C, Woerther PL, Lopinto J, Turpin M, Rousseau A, Lacoste-Badie R, Razazi K, Voiriot G, Fartoukh M. Combined use of respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in sickle-cell adult patients with acute chest syndrome (The ANTIBIO-STA study): a randomised, controlled, open-label trial. Lancet Reg Health Eur. 2025 Feb 7;51:101234. doi: 10.1016/j.lanepe.2025.101234. eCollection 2025 Apr.

  PMID: 39995490 RESULT

MeSH Terms

Conditions

Acute Chest Syndrome; Anemia, Sickle Cell

Interventions

Procalcitonin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Calcitonin; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Protein Precursors; Proteins

Study Officials

• Muriel FARTOUKH, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 18, 2019
• Study Start: June 2, 2020
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)