Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04158492
Status:
TERMINATED
Last Update Posted:
2023-04-28
First Post:
2019-10-28
Brief Title:
Impact of Comprehensive Molecular Tests on Antimicrobial Stewardship in Community-acquired Pneumonia
Sponsor:
Hospital Universitari de Bellvitge
Organization:
Hospital Universitari de Bellvitge
Study Overview
Official Title:
Impact of Comprehensive Molecular Tests on Antimicrobial Stewardship in Community-acquired Pneumonia an Open Controlled and Randomized Clinical Trial
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADICAP
Brief Summary:
Background Community-acquired pneumonia CAP continues to be a major health problem with significant mortality and its one of the main causes of antibiotic prescription Antibiotic overuse is a key driver of antimicrobial resistance and exposes patients to an increased risk of other antibiotic-related adverse events The investigators aim to assess if rapid molecular tests are an effective tool to reduce antibiotic use in CAP compared to routine microbiological testing
Design Randomized controlled open-label clinical trial with two parallel groups 11 settled in a two-year multicenter two tertiary care hospitals between 2019 and 2021 Eligible participants will be non-severely immunosuppressed adult patients hospitalized for CAP through the emergency department Primary endpoint will be antibiotic consumption measured by days of antibiotic therapy DOT per 1000 patient-days Secondary end points will be de-escalation to narrower antibiotic treatment time to switch from intravenous to oral antibiotics antibiotic-related side effects length of hospital stay days until clinical stability need for ICU admission need for hospital readmission in the 30 days after randomization death from any cause in the 30 days after randomization Patients will be randomly assigned to receive experimental diagnosis comprehensive molecular testing added to routine microbiological testing or standard diagnosis only microbiological routine testing A total of 220 patients are estimated in the experimental arm undergoing comprehensive molecular testing and 220 control subjects undergoing routine testing to be able to reject the null hypothesis that experimental and control groups have equal DOT per 1000 patients-days with a probability above 08
Discussion Comprehensive molecular tests could be a key tool in the optimization of etiological diagnostics in CAP and therefore a key element in antimicrobial stewardship programs developed to improve safety and antibiotic use in CAP
Design Randomized controlled open-label clinical trial with two parallel groups 11 settled in a two-year multicenter two tertiary care hospitals between 2019 and 2021 Eligible participants will be non-severely immunosuppressed adult patients hospitalized for CAP through the emergency department Primary endpoint will be antibiotic consumption measured by days of antibiotic therapy DOT per 1000 patient-days Secondary end points will be de-escalation to narrower antibiotic treatment time to switch from intravenous to oral antibiotics antibiotic-related side effects length of hospital stay days until clinical stability need for ICU admission need for hospital readmission in the 30 days after randomization death from any cause in the 30 days after randomization Patients will be randomly assigned to receive experimental diagnosis comprehensive molecular testing added to routine microbiological testing or standard diagnosis only microbiological routine testing A total of 220 patients are estimated in the experimental arm undergoing comprehensive molecular testing and 220 control subjects undergoing routine testing to be able to reject the null hypothesis that experimental and control groups have equal DOT per 1000 patients-days with a probability above 08
Discussion Comprehensive molecular tests could be a key tool in the optimization of etiological diagnostics in CAP and therefore a key element in antimicrobial stewardship programs developed to improve safety and antibiotic use in CAP
Detailed Description:
None
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