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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

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

Clinicaltrials.gov identifier NCT03919266

Recruitment Status Not yet recruiting

First Posted April 18, 2019

Last update posted February 19, 2020

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 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

  • Condition or Disease:Acute Chest Syndrome
    Sickle Cell Disease
  • Intervention/Treatment: Procedure: Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin
    Procedure: Control: usual antibiotic treatment
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • 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: February 2020
  • Estimated Primary Completion Date: February 2021
  • Estimated Study Completion Date: March 2021
Arms and interventions
Arm Intervention/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
Other: Control
usual antibiotic treatment
Procedure: Control: usual antibiotic treatment
usual antibiotic treatment
Outcome Measures
  • 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. Global utilization of antibiotics at 28 days [ Time Frame: Day 28 ]
  • 2. Time before clinical stability at 28 days [ Time Frame: Day 28 ]
  • 3. transfusion and exchange transfusion at 28 days [ Time Frame: Day 28 ]
  • 4. Amount of morphine given to patients at 28 days [ Time Frame: Day 28 ]
  • 5. ICU and hospital lengths of stay [ Time Frame: Day 28 ]
  • 6. Readmission rate in hospital at 28 days [ Time Frame: Day 28 ]
  • 7. Rate of microbiological documentation of ACS [ Time Frame: Day 28 ]
  • 8. Transfer to ICU at 28 days (D28) after the diagnosis of ACS between the two [ Time Frame: Day 28 ]
  • 9. Survival at 28 days [ Time Frame: Day 28 ]
  • 10. occurrence of a secondary bacterial respiratory infection or any other secondary infection at 28 days [ Time Frame: Day 28 ]
Eligibility Criteria
  • 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

Contacts and Locations
Contacts

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

France
Service de Réanimation et USC médico-chirurgicale
Paris

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Muriel FARTOUKH, PU-PH Assistance Publique - Hôpitaux de Paris

More Information
  • 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: February 19, 2020
  • Last Verified: February 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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: Acute Chest Syndrome
    Anemia, Sickle Cell
    Syndrome