Ignite Creation Date:
2024-05-06 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03452826
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2018-02-26
Brief Title:
Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia
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 Patients With Severe Community-Acquired Pneumonia a Multicentre Parallel-group Open-label Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-10
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:
MULTI-CAP
Brief Summary:
To assess the effectiveness of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin intervention in severe CAP as compared to a conventional strategy control
A multicentre parallel-group open-label randomized controlled trial The primary assessment criterion est the number of antibiotic-free days at 28 days
A multicentre parallel-group open-label randomized controlled trial The primary assessment criterion est the number of antibiotic-free days at 28 days
Detailed Description:
Randomization is performed immediately after the inclusion
In the intervention arm a broad panel respiratory mPCR is performed on a lower respiratory tract sample bronchoalveolar lavage fluid or tracheal aspirate otherwise sputum collected before the 12th hour following inclusion
In both arms an additional lower respiratory tract sample bronchoalveolar lavage fluid or tracheal aspirate otherwise sputum is collected for biological studies and banking
In the intervention arm an algorithm of early antibiotic de-escalation and discontinuation is based on the early microbiological results including the mPCR results and the procalcitonin value This algorithm is applied as soon as possible before the 24th hour following inclusion if possible
In the control arm initial antibiotic therapy is maintained according to guidelines
In both arms after 72 hours of antibiotic therapy ICU physicians are advised to use procalcitonin values and kinetics to guide antibiotic therapy discontinuation with a recommended total duration of 7 days unless otherwise indicated
In both arms a switch to oral therapy is encouraged
In the intervention arm a broad panel respiratory mPCR is performed on a lower respiratory tract sample bronchoalveolar lavage fluid or tracheal aspirate otherwise sputum collected before the 12th hour following inclusion
In both arms an additional lower respiratory tract sample bronchoalveolar lavage fluid or tracheal aspirate otherwise sputum is collected for biological studies and banking
In the intervention arm an algorithm of early antibiotic de-escalation and discontinuation is based on the early microbiological results including the mPCR results and the procalcitonin value This algorithm is applied as soon as possible before the 24th hour following inclusion if possible
In the control arm initial antibiotic therapy is maintained according to guidelines
In both arms after 72 hours of antibiotic therapy ICU physicians are advised to use procalcitonin values and kinetics to guide antibiotic therapy discontinuation with a recommended total duration of 7 days unless otherwise indicated
In both arms a switch to oral therapy is encouraged
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 |
|---|---|---|---|
| AO 1615-48 | OTHER_GRANT | PHRC | None |