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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interleukin 6-guided antibiotic therapy (Interleukin-6 group) | Experimental | After randomization, baseline blood samples will be drawn within 2 hours. Prescribing clinician are able to access the results of the IL-6 through the internal network of the hospital. Participants' antibiotic prescription decisions will made according to the results. The detailed recommendations are as follows: if Interleukin-6<10 pg/ml，strongly discouraged；if Interleukin-6 (10-30 pg/ml) and no sputum purulence, discouraged; if Interleukin-6 (10-30 pg/ml) and sputum purulence, Recommended; Interleukin-6>30 pg /ml, Strongly recommended. |
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| GOLD-guided antibiotic therapy (GOLD group) | Active Comparator | After randomization, baseline blood samples will also need to be drawn within 2 hours. Prescribing clinician are able to access all results through the internal network of the hospital. Participants' antibiotic prescription decisions will made according to the recommendations of GOLD guideline. The guideline recommends antibiotic therapy for the following patients: those with COPD exacerbations presenting with all three cardinal symptoms (increased dyspnea, sputum volume, and sputum purulence); those with two of the cardinal symptoms, provided that increased purulence of sputum is one of them; or those who need mechanical ventilation (either invasive or noninvasive). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interleukin 6-guided antibiotic therapy | Drug | In Interleukin-6 group, antibiotic prescription decisions will made according to the results of IL-6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of antibiotic use | Ratio of AECOPD patients given antibiotics | 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). | During the 30-day period after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of antibiotic use | Ratio of AECOPD patients given antibiotics | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 依婷 Cao | Contact | +86-0574-87089878 | liyiting1022@163.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| GOLD-guided antibiotic therapy | Drug | In guideline group, antibiotic prescription decisions will made according to the recommendations of GOLD guideline. |
|
| Between randomization and discharge, limited to 30 days |
| Duration of hospitalization | Total days of hospitalization until study completion, averaging 30 days | Between randomization and discharge, limited to 30 days |
| Frequency of subsequent exacerbations | Ratio of patients who develop a subsequent acute exacerbation following recovery | During the 30-day period after randomization |
| Incidence of hospital readmission | Ratio of patients rehospitalized for AECOPD following discharge | Between the discharge date and 30 days post-randomization |
| All-cause mortality | Death due to any cause | During the 30-day period after randomization |
| Frequency of ICU admissions | Ratio of patients admitted to the intensive care unit | During the 30-day period after randomization |
| noninvasive mechanical ventilation | Ratio of patients provided with non-invasive mechanical ventilation | 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 | 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 | 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 | 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 | From the initial hospital admission baseline to 30 days after randomization |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |