Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612476
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients a Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this multicenter prospective randomized controlled study we aimed to figure out compared with the global chronic obstructive pulmonary disease initiative GOLD guideline -guided antibiotic therapy whether Interleukin 6 IL6-guided antibiotic therapy for acute exacerbation of chronic obstructive pulmonary disease AECOPD can lead to a reduction in the use of antibiotics without increasing the rate of treatment failure
Detailed Description:
Acute exacerbation is the first leading cause of hospitalization and mortality among patients with COPD Infection of bacteria has been detected in 4959 of patients with AECOPD Antibiotic prescriptions for AECOPD patients are usually based on GOLD guideline However the newest study reported that more than 85 of AECOPD inpatients received antibiotic prescription in the United States Europe and China Not all patients will equally experience benefit from antibiotics Interleukin 6 IL6 was determined as a reliable clinical biomarker in guiding antimicrobial use It remains unclear whether IL6-guided antibiotic therapy is safe and effective for hospitalized patients with AECOPD
The study will recruit 440 AECOPD inpatients from at least six hospitals based in China Eligible participants will be assigned to receive either IL6-guided antibiotic therapy or GOLD-guided antibiotic therapy in 11 ratio randomly The hypothesis for this study is that IL-6 guided antibiotic therapy will reduce the rate of antibiotic prescriptions for AECOPD without increasing the rate of treatment failure compared with the group treated with GOLD-guided antibiotic therapy
The study will recruit 440 AECOPD inpatients from at least six hospitals based in China Eligible participants will be assigned to receive either IL6-guided antibiotic therapy or GOLD-guided antibiotic therapy in 11 ratio randomly The hypothesis for this study is that IL-6 guided antibiotic therapy will reduce the rate of antibiotic prescriptions for AECOPD without increasing the rate of treatment failure compared with the group treated with GOLD-guided antibiotic therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None