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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. (Antibio_STA)

Primary Purpose

Acute Chest Syndrome, Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin
Control: usual antibiotic treatment
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Chest Syndrome focused on measuring Acute chest syndrome, SCD, PCR multiplex, antibiotic treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Réanimation et USC médico-chirurgicale

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Intervention

Arm Description

usual antibiotic treatment

targeted antibiotic treatment according to the results of PCR multiplex

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2019
Last Updated
June 28, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03919266
Brief Title
Combined Use of a Respiratory Broad Panel Multiplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Hospitalized Sickle-cell Adults With Acute Chest Syndrome.
Acronym
Antibio_STA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 2, 2020 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Chest Syndrome, Sickle Cell Disease
Keywords
Acute chest syndrome, SCD, PCR multiplex, antibiotic treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
usual antibiotic treatment
Arm Title
Intervention
Arm Type
Experimental
Arm Description
targeted antibiotic treatment according to the results of PCR multiplex
Intervention Type
Procedure
Intervention Name(s)
Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin
Intervention Description
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 Type
Procedure
Intervention Name(s)
Control: usual antibiotic treatment
Intervention Description
usual antibiotic treatment
Primary Outcome Measure Information:
Title
to compare the antibiotics exposure at 28 days (D28) after the diagnosis of ACS between the two strategies
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Rate of microbiological documentation of ACS
Time Frame
Day 28
Title
Transfer to ICU at 28 days (D28) after the diagnosis of ACS between the two strategies
Time Frame
Day 28
Title
Survival at 28 days
Time Frame
Day 28
Title
occurrence of a secondary bacterial respiratory infection or any other secondary infection at 28 days
Time Frame
Day 28
Title
Global use of antibiotics at 28 days
Time Frame
Day 28
Title
Time to clinical stability at 28 days
Time Frame
Day 28
Title
transfusion and exchange transfusion at 28 days
Time Frame
Day 28
Title
ICU and hospital lengths of stay
Time Frame
Day 28
Title
Readmission rate in hospital at 28 days
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muriel FARTOUKH, PU-PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Réanimation et USC médico-chirurgicale
City
Paris
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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