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Trial record 34 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

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

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ClinicalTrials.gov Identifier: NCT03919266
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

We hypothesize 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


Condition or disease Intervention/treatment Phase
Acute Chest Syndrome Sickle Cell Disease Procedure: Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin Procedure: Control: usual antibiotic treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Control
usual antibiotic treatment
Procedure: Control: usual antibiotic treatment
usual antibiotic treatment

Experimental: Intervention
targeted antibiotic treatment according to the results of PCR multiplex
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




Primary Outcome Measures :
  1. to compare the antibiotics exposure at 28 days (D28) after the diagnosis of ACS between the two strategies [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. Rate of microbiological documentation of ACS [ Time Frame: Day 28 ]
  2. Transfer to ICU at 28 days (D28) after the diagnosis of ACS between the two [ Time Frame: Day 28 ]
  3. Survival at 28 days [ Time Frame: Day 28 ]
  4. occurrence of a secondary bacterial respiratory infection or any other secondary infection at 28 days [ Time Frame: Day 28 ]
  5. Global utilization of antibiotics at 28 days [ Time Frame: Day 28 ]
  6. Time before clinical stability at 28 days [ Time Frame: Day 28 ]
  7. transfusion and exchange transfusion at 28 days [ Time Frame: Day 28 ]
  8. Amount of morphine given to patients at 28 days [ Time Frame: Day 28 ]
  9. ICU and hospital lengths of stay [ Time Frame: Day 28 ]
  10. Readmission rate in hospital at 28 days [ Time Frame: Day 28 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919266


Contacts
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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

Locations
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France
Service de Réanimation et USC médico-chirurgicale Not yet recruiting
Paris, France, 75020
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   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Muriel FARTOUKH, PU-PH Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03919266     History of Changes
Other Study ID Numbers: APHP180159
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute chest syndrome
SCD
PCR multiplex
antibiotic treatment
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Acute Chest Syndrome
Anemia, Sickle Cell
Syndrome
Disease
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders