Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04682899
Status:
UNKNOWN
Last Update Posted:
2020-12-24
First Post:
2020-12-08
Brief Title:
A Trial of Procalcitonin in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Sponsor:
Capital Medical University
Organization:
Capital Medical University
Study Overview
Official Title:
Procalcitonin-guided Initiation of Antibiotics in AECOPD Inpatients a Multicenter Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
Current antibiotic prescription for patients with acute exacerbation of chronic obstructive pulmonary disease AECOPD is generally based on the Anthonisen criteria in The Global Initiative for Chronic Obstructive Pulmonary Disease GOLD guideline that has a potential risk of antibiotics overuse The dilemma is to identify patients who are most likely to benefit from antibiotics while avoiding unnecessary antibiotic use Procalcitonin PCT a more sensitive and specific biomarker of bacterial infection than other conventional laboratory tests has the potential to determine those patients in whom antibiotics would be beneficial It is unclear whether PCT-guided antibiotic therapy is safe and effective for inpatients with AECOPD The investigators aim to conduct a 2-arm multicenter randomized controlled trial in China to determine whether PCT-guided antibiotic therapy will reduce the antibiotic prescription rate for AECOPD without negatively impacting the treatment success rate compared with the GOLD guideline antibiotic recommendations
Detailed Description:
This trial will recruit 500 hopitalized patients with AECOPD The eligible participants will be randomly assigned to either PCT group or guideline groupThe investigators aim to compare the efficacy and safety between PCT-gudied antibiotic therapy and guideline-guided antibiotic recommendations The primary hypothesis is that PCT-guided antibiotic therapy will reduce the antibiotic prescription rate for AECOPD without negatively impacting the treatment success rate compared with the GOLD guideline antibiotic recommendations
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