Ignite Creation Date:
2024-05-06 @ 8:04 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02668237
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2016-01-22
Brief Title:
Early Molecular Detection Technique Coupled With Urinary Test of Infectious Agents Responsible of Children CAP
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Impact on Anti-infectious Treatments of the Early Molecular Detection Technique Coupled With Urinary Test of Infectious Agents Responsible of Community-acquired Pneumonia of Children at Pediatric Emergencies
Status:
COMPLETED
Status Verified Date:
2019-07
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:
OptiPAC
Brief Summary:
Community-Acquired Pneumonia CAP of children are a recurrent pathology with multiple severity scores The etiology is never really identified and the initial treatment is always based on probabilistic antibiotics in the case of an bacterial infection and by the way potentially severe
Molecular tests multiplex allow the simultaneous detection of a huge number of pathogenic agents virus and bacteria are now available
This project is based on a new strategy of diagnostic using a multiplex PCR with quick results coupled to an antigenic urinary test to allow a complete quick etiologic diagnostic as soon as children are supported in emergency
Children are randomized in two groups during inclusions quick diagnostic strategy versus usual practice Analyse will be centralized on anti-infectious treatment optimization with the aim to better treat patients minimize the costs and decrease selection pressure of multi-resistant bacteria
Molecular tests multiplex allow the simultaneous detection of a huge number of pathogenic agents virus and bacteria are now available
This project is based on a new strategy of diagnostic using a multiplex PCR with quick results coupled to an antigenic urinary test to allow a complete quick etiologic diagnostic as soon as children are supported in emergency
Children are randomized in two groups during inclusions quick diagnostic strategy versus usual practice Analyse will be centralized on anti-infectious treatment optimization with the aim to better treat patients minimize the costs and decrease selection pressure of multi-resistant bacteria
Detailed Description:
Community-Acquired Pneumonia CAP of children are a recurrent pathology with multiple severity scores Almost two out of three cases identified at emergency are treated in ambulatory because patients present a reassuring clinical state The etiology is never really identified and the initial treatment is always based on probabilistic antibiotics re-evaluated at H48 in the case of an bacterial infection and by the way potentially severe This old conception is opposed to the new discoveries more particularly in pediatric units where strictly viral pneumonia are more important than predicted at least 30 to 50 that leads to an hyper prescription of antibiotics useless
Molecular tests multiplex allow the simultaneous detection of a huge number of pathogenic agents virus and bacteria are now available
Aware of the non specificity of the clinical data to guide the diagnostic this project is based on a new strategy of diagnostic using a multiplex PCR with quick results less than 2 hours for 20 pathogens including 17 viruses coupled to an antigenic urinary test to allow a complete quick etiologic diagnostic as soon as children are supported in emergency
Children are randomized in two groups during inclusions quick diagnostic strategy versus usual practice Analyse will be centralized on anti-infectious treatment optimization antibiotics and antiviruses with the aim to better treat patients minimize the costs and decrease selection pressure of multi-resistant bacteria
Molecular tests multiplex allow the simultaneous detection of a huge number of pathogenic agents virus and bacteria are now available
Aware of the non specificity of the clinical data to guide the diagnostic this project is based on a new strategy of diagnostic using a multiplex PCR with quick results less than 2 hours for 20 pathogens including 17 viruses coupled to an antigenic urinary test to allow a complete quick etiologic diagnostic as soon as children are supported in emergency
Children are randomized in two groups during inclusions quick diagnostic strategy versus usual practice Analyse will be centralized on anti-infectious treatment optimization antibiotics and antiviruses with the aim to better treat patients minimize the costs and decrease selection pressure of multi-resistant bacteria
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-A00483-48 | OTHER | ANSM | None |
| 16-367 | OTHER | None | None |
| 916352 | OTHER | None | None |