Nctid:
NCT06612476
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008173", "term"=>"Lung Diseases, Obstructive"}, {"id"=>"D000029424", "term"=>"Pulmonary Disease, Chronic Obstructive"}], "ancestors"=>[{"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000002908", "term"=>"Chronic Disease"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M11170", "name"=>"Lung Diseases, Obstructive", "asFound"=>"Obstructive Pulmonary Disease", "relevance"=>"HIGH"}, {"id"=>"M23449", "name"=>"Pulmonary Disease, Chronic Obstructive", "asFound"=>"Chronic Obstructive Pulmonary Disease", "relevance"=>"HIGH"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000000904", "term"=>"Antibiotics, Antitubercular"}], "ancestors"=>[{"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000000995", "term"=>"Antitubercular Agents"}], "browseLeaves"=>[{"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "asFound"=>"Well", "relevance"=>"HIGH"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "asFound"=>"Well", "relevance"=>"HIGH"}, {"id"=>"M4311", "name"=>"Antitubercular Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>440}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-20", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-08-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-21", "studyFirstSubmitDate"=>"2024-09-21", "studyFirstSubmitQcDate"=>"2024-09-21", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-08-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Incidence of antibiotic use", "timeFrame"=>"During the 30-day period after randomization", "description"=>"Ratio of AECOPD patients given antibiotics"}, {"measure"=>"Proportion of successful treatments", "timeFrame"=>"During the 30-day period after randomization", "description"=>"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)."}], "secondaryOutcomes"=>[{"measure"=>"Incidence of antibiotic use", "timeFrame"=>"During the first day period after randomization", "description"=>"Ratio of AECOPD patients given antibiotics"}, {"measure"=>"Antibiotic utilization in the hospital", "timeFrame"=>"Between randomization and discharge, limited to 30 days", "description"=>"Duration of antibiotic consumption for AECOPD and the percentage of patients treated with antibiotics for AECOPD from randomization to hospital discharge"}, {"measure"=>"Duration of hospitalization", "timeFrame"=>"Between randomization and discharge, limited to 30 days", "description"=>"Total days of hospitalization until study completion, averaging 30 days"}, {"measure"=>"Frequency of subsequent exacerbations", "timeFrame"=>"During the 30-day period after randomization", "description"=>"Ratio of patients who develop a subsequent acute exacerbation following recovery"}, {"measure"=>"Incidence of hospital readmission", "timeFrame"=>"Between the discharge date and 30 days post-randomization", "description"=>"Ratio of patients rehospitalized for AECOPD following discharge"}, {"measure"=>"All-cause mortality", "timeFrame"=>"During the 30-day period after randomization", "description"=>"Death due to any cause"}, {"measure"=>"Frequency of ICU admissions", "timeFrame"=>"During the 30-day period after randomization", "description"=>"Ratio of patients admitted to the intensive care unit"}, {"measure"=>"noninvasive mechanical ventilation", "timeFrame"=>"During the 30-day period after randomization", "description"=>"Ratio of patients provided with non-invasive mechanical ventilation"}, {"measure"=>"Change in COPD assessment test", "timeFrame"=>"From the initial hospital admission baseline to 30 days after randomization", "description"=>"The variation from the baseline at hospital admission to 30 days after randomization"}, {"measure"=>"Change in St. George's Respiratory Questionnaire", "timeFrame"=>"From the initial hospital admission baseline to 30 days after randomization", "description"=>"The variation from the baseline at hospital admission to 30 days after randomization"}, {"measure"=>"Change in modified Medical Research Council (mMRC) score", "timeFrame"=>"From the initial hospital admission baseline to 30 days after randomization", "description"=>"The variation from the baseline at hospital admission to 30 days after randomization"}, {"measure"=>"Change in Hospital Anxiety and Depression Scale", "timeFrame"=>"From the initial hospital admission baseline to 30 days after randomization", "description"=>"The variation from the baseline at hospital admission to 30 days after randomization"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Aecopd", "Interleukin 6", "antibiotic therapy"], "conditions"=>["Chronic Obstructive Pulmonary Disease, COPD"]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"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.\n\nThe 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"40 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"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/day 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"}, "identificationModule"=>{"nctId"=>"NCT06612476", "briefTitle"=>"Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients", "organization"=>{"class"=>"OTHER", "fullName"=>"Ningbo No. 1 Hospital"}, "officialTitle"=>"Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients: a Multicenter Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"2024-R046-02"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Interleukin 6-guided antibiotic therapy (Interleukin-6 group)", "description"=>"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.", "interventionNames"=>["Drug: Interleukin 6-guided antibiotic therapy"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"GOLD-guided antibiotic therapy (GOLD group)", "description"=>"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).", "interventionNames"=>["Drug: GOLD-guided antibiotic therapy"]}], "interventions"=>[{"name"=>"Interleukin 6-guided antibiotic therapy", "type"=>"DRUG", "description"=>"In Interleukin-6 group, antibiotic prescription decisions will made according to the results of IL-6.", "armGroupLabels"=>["Interleukin 6-guided antibiotic therapy (Interleukin-6 group)"]}, {"name"=>"GOLD-guided antibiotic therapy", "type"=>"DRUG", "description"=>"In guideline group, antibiotic prescription decisions will made according to the recommendations of GOLD guideline.", "armGroupLabels"=>["GOLD-guided antibiotic therapy (GOLD group)"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"依婷 Cao", "role"=>"CONTACT", "email"=>"liyiting1022@163.com", "phone"=>"+86-0574-87089878"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ningbo No. 1 Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
