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Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients: a Multicenter Randomized Controlled Trial
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.
Acute exacerbation is the first leading cause of hospitalization and mortality among patients with COPD. Infection of bacteria has been detected in 49.59% 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 1:1 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.
Age
40 - 80 years
Sex
ALL
Healthy Volunteers
No
Start Date
September 20, 2024
Primary Completion Date
August 31, 2026
Completion Date
August 31, 2026
Last Updated
September 25, 2024
440
ESTIMATED participants
Interleukin 6-guided antibiotic therapy
DRUG
GOLD-guided antibiotic therapy
DRUG
Lead Sponsor
Ningbo No. 1 Hospital
NCT02442206
NCT00496470
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