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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
440
In Interleukin-6 group, antibiotic prescription decisions will made according to the results of IL-6.
In guideline group, antibiotic prescription decisions will made according to the recommendations of GOLD guideline.
Incidence of antibiotic use
Ratio of AECOPD patients given antibiotics
Time frame: During the 30-day period after randomization
Proportion of successful treatments
Treatment success is achieved when there is a cure (full resolution of all symptoms and signs of the exacerbation) or improvement (diminishment or resolution of symptoms and signs from the exacerbation, with no additional symptoms or signs).
Time frame: During the 30-day period after randomization
Incidence of antibiotic use
Ratio of AECOPD patients given antibiotics
Time frame: During the first day period after randomization
Antibiotic utilization in the hospital
Duration of antibiotic consumption for AECOPD and the percentage of patients treated with antibiotics for AECOPD from randomization to hospital discharge
Time frame: Between randomization and discharge, limited to 30 days
Duration of hospitalization
Total days of hospitalization until study completion, averaging 30 days
Time frame: Between randomization and discharge, limited to 30 days
Frequency of subsequent exacerbations
Ratio of patients who develop a subsequent acute exacerbation following recovery
Time frame: During the 30-day period after randomization
Incidence of hospital readmission
Ratio of patients rehospitalized for AECOPD following discharge
Time frame: Between the discharge date and 30 days post-randomization
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All-cause mortality
Death due to any cause
Time frame: During the 30-day period after randomization
Frequency of ICU admissions
Ratio of patients admitted to the intensive care unit
Time frame: During the 30-day period after randomization
noninvasive mechanical ventilation
Ratio of patients provided with non-invasive mechanical ventilation
Time frame: During the 30-day period after randomization
Change in COPD assessment test
The variation from the baseline at hospital admission to 30 days after randomization
Time frame: From the initial hospital admission baseline to 30 days after randomization
Change in St. George's Respiratory Questionnaire
The variation from the baseline at hospital admission to 30 days after randomization
Time frame: From the initial hospital admission baseline to 30 days after randomization
Change in modified Medical Research Council (mMRC) score
The variation from the baseline at hospital admission to 30 days after randomization
Time frame: From the initial hospital admission baseline to 30 days after randomization
Change in Hospital Anxiety and Depression Scale
The variation from the baseline at hospital admission to 30 days after randomization
Time frame: From the initial hospital admission baseline to 30 days after randomization