[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563154":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":26,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":26,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":26},{"fullName":5,"class":6},"Ningbo No. 1 Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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\\\u003C10 pg\u002Fml，strongly discouraged；if Interleukin-6 (10-30 pg\u002Fml) and no sputum purulence, discouraged; if Interleukin-6 (10-30 pg\u002Fml) and sputum purulence, Recommended; Interleukin-6\\>30 pg \u002Fml, Strongly recommended.",[13],"Drug: Interleukin 6-guided antibiotic therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"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).",[19],"Drug: GOLD-guided antibiotic therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Interleukin 6-guided antibiotic therapy","In Interleukin-6 group, antibiotic prescription decisions will made according to the results of IL-6.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"GOLD-guided antibiotic therapy","In guideline group, antibiotic prescription decisions will made according to the recommendations of GOLD guideline.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"依婷 Cao","CONTACT","+86-0574-87089878","liyiting1022@163.com",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100563154","interleukin-6-guided-antibiotic-prescriptions-in-aecopd-inpatients-100563154",false,"NCT06612476","Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients","Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients: a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. AECOPD patients admitted to hospitals\n2. The exacerbation has lasted for at least 24 hours but equal to or less than 21 days\n3. ≥40 years of age but no more than 80 years old\n4. With at least 10 pack-year history of smoking\n5. Able to provide written informed consent and ensure the completion of the trial\n\nExclusion Criteria:\n\n1. Axillary temperature≥38°C\n2. Acute pneumonia identified by X-Ray or CT of the chest\n3. Severe respiratory failure requiring admittance to ICU\n4. Comorbidities require antibiotic therapy (i.e. infection at another site, systematic infection, active chronic inflammatory condition, specific viral infection)\n5. Immunosuppression status (i.e., patients with HIV infection, with malignant tumor of blood system, receiving chemotherapy)\n6. Concurrent diseases requiring corticosteroids (equivalent to 60mg prednisone\u002Fday or more than 30 days)\n7. Antibiotic use in the previous four weeks\n8. Current tracheotomy status\n9. Bronchiectasis of origin other than COPD\n10. Invasive mechanical ventilation\n11. Patients diagnosed malignant tumors\n12. Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.\n13. Newly diagnosed pulmonary embolism\n14. Participation in another clinical trial","ALL","40 Years","80 Years",{"count":50,"type":51},440,"ESTIMATED","INTERVENTIONAL",[54],"NA","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.",[57],"Chronic Obstructive Pulmonary Disease, COPD",[59,60,61],"Aecopd","Interleukin 6","antibiotic therapy","NOT_YET_RECRUITING","2024-09-21",{"date":65,"type":66},"2024-09-25","ACTUAL",{"date":68,"type":51},"2024-09-20",{"date":70,"type":51},"2026-08-31",{"name":5,"class":6}]