[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599584":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":10,"centralContacts":10,"locations":22,"responsibleParty":41,"collaborators":10,"id":45,"slug":10,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":10,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":57,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":10,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Fujian Medical University Union Hospital","OTHER",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Group A: 25mg polymyxin B + 5ml sterile water via jet nebulizer (respirator-assisted).",null,[12],"Device: Polymyxin B Sulfate 25mg Jet Nebulization \u002F Vibrating Mesh Nebulization",{"label":14,"type":10,"description":10,"interventionNames":15},"Group B: 25mg polymyxin B + 5ml sterile water via vibrating mesh nebulizer (respirator-assisted).",[12],[17],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"DEVICE","Polymyxin B Sulfate 25mg Jet Nebulization \u002F Vibrating Mesh Nebulization","* Group A: 25mg polymyxin B sulfate dissolved in 5ml sterile water, administered via jet nebulizer under mechanical ventilation.\n* Group B: 25mg polymyxin B sulfate dissolved in 5ml sterile water, administered via vibrating mesh nebulizer under mechanical ventilation.",[9,14],[23],{"facility":5,"status":24,"city":25,"state":26,"zip":27,"country":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"RECRUITING","Fuzhou","Fujian","350001","China",{"type":30,"coordinates":31},"Point",[32,33],119.30611,26.06139,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"lili Zhou, MD，MS","CONTACT","15377906840","zhoulili@fjmu.edu.cn",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Lili Zhou","Associate Chief Physician","100599584",false,"NCT07086391","Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.","A Prospective Clinical Study on Different Methods of Aerosolized Polymyxin B Inhalation for the Treatment of Carbapenem-Resistant Gram-Negative Bacterial Pneumonia","Inclusion Criteria:\n\n* Pneumonia diagnosed per Chinese Thoracic Society criteria (radiographic + clinical evidence).\n* Sputum culture-confirmed carbapenem-resistant Gram-negative bacteria susceptible to polymyxin B.\n* ≥3 days of aerosolized polymyxin B therapy.\n* Mechanically ventilated with an artificial airway.\n\nExclusion Criteria:\n\n* Polymyxin B aerosol use planned for \\\u003C3 days.\n* Terminal status (life expectancy \\\u003C48h).\n* Severe liver\u002Fkidney dysfunction (ALT\u002FAST \\>5× ULN; eGFR \\\u003C30 mL\u002Fmin).\n* No informed consent.","ALL","18 Years","90 Years",{"count":55,"type":56},144,"ESTIMATED","28 Days","OBSERVATIONAL","Study Design:\n\nA randomized, open-label, parallel-group clinical trial comparing the efficacy and safety of jet nebulization versus vibrating mesh nebulization of sulfate polymyxin B in mechanically ventilated patients with carbapenem-resistant Gram-negative bacterial pneumonia.\n\nParticipants:\n\n144 patients (72 per group) will be enrolled from December 2023 to December 2025.\n\nInterventions:\n\nGroup A: 25mg polymyxin B + 5ml sterile water via jet nebulizer (respirator-assisted).\n\nGroup B: 25mg polymyxin B + 5ml sterile water via vibrating mesh nebulizer (respirator-assisted).\n\nBoth groups receive additional intravenous polymyxin B (2.0mg\u002Fkg loading dose, followed by 1.25mg\u002Fkg every 12h) starting 12h after nebulization.\n\nTreatment duration: 14 days.\n\nKey Procedures:\n\nNebulization parameters: Fixed ventilator settings (SIMV+PSV mode, tidal volume 8ml\u002Fkg, PEEP 6cmH₂O).\n\nBronchoalveolar lavage (BAL) and blood sampling:\n\nBAL fluid (BALF) and blood collected pre-nebulization (baseline), 1h post-nebulization, and at steady-state (days 3-7).\n\nBALF analyzed for polymyxin B concentration, urea nitrogen, and inflammatory mediators (IL-6, TNF-α, etc.).\n\nPrimary Outcomes:\n\nClinical efficacy:\n\nTotal response rate (cure + improvement). 28-day survival rate. Time to fever resolution and bacterial clearance.\n\nDrug exposure:\n\nPolymyxin B concentration in alveolar epithelial lining fluid (ELF) and blood.\n\nSecondary Outcomes:\n\nInflammatory response: Changes in BALF and serum IL-6, TNF-α, CRP levels.\n\nSafety:\n\nNephrotoxicity (changes in serum creatinine\u002Furea nitrogen). Airway complications (bronchospasm incidence).\n\nAssessment Timeline:\n\nClinical monitoring: Daily evaluation of vital signs, sputum volume, and ventilator parameters.\n\nLab tests: Blood tests (hematology, renal function, inflammatory markers) at baseline, days 3\u002F7\u002F14.\n\nMicrobiological evaluation: Sputum cultures on days 3\u002F7\u002F14.\n\nStatistical Analysis:\n\nEfficacy and safety endpoints compared between groups using t-tests or chi-square tests.\n\nA p-value \\\u003C0.05 will be considered statistically significant.",[61,62],"Carbapenem-Resistant Enterobacteriaceae Infection","Pneumonia - Bacterial","2025-07-18",{"date":65,"type":66},"2025-07-25","ACTUAL",{"date":68,"type":66},"2023-02-01",{"date":70,"type":56},"2026-02-01",{"name":5,"class":6},1]