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.
This trial will recruit 500 hopitalized patients with AECOPD. The eligible participants will be randomly assigned to either PCT group or guideline group.The 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
In procalcitonin group, clinican make a decision of antibiotic precription based on the results of procalcitonin.
In guideline group, clinican make a decision of antibiotic precription based on the recommendations of GOLD guideline.
Antibiotic prescription rate
proportion of patients receiving antibiotics for AECOPD
Time frame: within 30 days post randomization
Treatment success rate
Treatment success is defined as cure (a complete resolution of signs and symptoms associated with the exacerbation) or improvement (a resolution or reduction of the symptoms and signs associated with the exacerbation, without new symptoms or signs).
Time frame: day 30 post randomization
Antibiotic prescription rate
the proportion of patients receiving antibiotics for AECOPD
Time frame: day 1 post randomization
Hospital antibiotic exposure
the number of days of antibiotic consumed for AECOPD and the proportion of patients receiving antibiotic for AECOPD between randomization and hospital discharge
Time frame: from randomization to hospital discharge, up to 30 days
Length of hospital stay
the number of days of hospitalization through study completion, an average of 30 days
Time frame: from randomization to hospital discharge, up to 30 days
Rate of subsequent exacerbation
proportion of patients present with subsequent acute exacerbation after recovery
Time frame: within 30 days post randomization
rate of hospital readmission
proportion of patients admit to hospital due to AECOPD after discharge
Time frame: from the date of discharge to day 30 post randomization
overall mortality
death from all cause
Time frame: within 30 days post randomization
ICU admission rate
proportion of patients admit to ICU
Time frame: within 30 days post randomization
Change in COPD assessment test
the difference between the baseline of hospital admission and day 30 post randomization
Time frame: from the baseline of hospital admission to day 30 post randomization
Change in modified Medical Research Council (mMRC) score
the difference between the baseline of hospital admission and day 30 post randomization
Time frame: from the baseline of hospital admission to day 30 post randomization
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