Ignite Creation Date:
2024-05-06 @ 1:01 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03919266
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2019-04-15
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
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Antibio_STA
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
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 symptoms 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None