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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03919266|
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : November 9, 2021
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||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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 2, 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
usual antibiotic treatment
Procedure: Control: usual antibiotic treatment
usual antibiotic treatment
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
- to compare the antibiotics exposure at 28 days (D28) after the diagnosis of ACS between the two strategies [ Time Frame: Day 28 ]
- 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 ]
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
|Contact: Muriel FARTOUKH, PU-PH||01 56 01 65 email@example.com|
|Contact: Guillaume VOIRIOT, MD||01 56 01 65 firstname.lastname@example.org|
|Principal Investigator:||Muriel FARTOUKH, PU-PH||Assistance Publique - Hôpitaux de Paris|