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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)

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ClinicalTrials.gov Identifier: NCT03919266
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date February 17, 2021
Actual Study Start Date  ICMJE June 2, 2020
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
to compare the antibiotics exposure at 28 days (D28) after the diagnosis of ACS between the two strategies [ Time Frame: Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2021)
  • 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 [ 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 utilization of antibiotics at 28 days [ Time Frame: Day 28 ]
  • Time before 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • 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 [ 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 utilization of antibiotics at 28 days [ Time Frame: Day 28 ]
  • Time before clinical stability at 28 days [ Time Frame: Day 28 ]
  • transfusion and exchange transfusion at 28 days [ Time Frame: Day 28 ]
  • Amount of morphine given to patients 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Use of a Respiratory Broad Panel Multiplex PCR and Procalcitonin to Reduce Antibiotics Exposure in Hospitalized Sickle-cell Adults With Acute Chest Syndrome.
Official Title  ICMJE 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
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 hypothesize 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 benefice-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 security 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Chest Syndrome
  • Sickle Cell Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Control
    usual antibiotic treatment
    Intervention: Procedure: Control: usual antibiotic treatment
  • Experimental: Intervention
    targeted antibiotic treatment according to the results of PCR multiplex
    Intervention: Procedure: Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2019)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Muriel FARTOUKH, PU-PH 01 56 01 65 74 muriel.fartoukh@aphp.fr
Contact: Guillaume VOIRIOT, MD 01 56 01 65 74 guillaume.voiriot@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919266
Other Study ID Numbers  ICMJE APHP180159
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Muriel FARTOUKH, PU-PH Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP