[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582141":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":46,"centralContacts":51,"locations":42,"responsibleParty":57,"collaborators":42,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":42,"enrollmentInfo":69,"targetDuration":42,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":88,"whyStopped":42,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":42},{"fullName":5,"class":6},"Copenhagen Respiratory Research","NETWORK",[8,14,20,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Asthma - Active","ACTIVE_COMPARATOR","Admitted asthma patient recieving active inhalations",[13],"Drug: Levofloxacin",{"label":15,"type":16,"description":17,"interventionNames":18},"Asthma - Placebo","PLACEBO_COMPARATOR","Admitted asthma patient recieving placebo inhalations",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Chronic obstructive pulmonary disease - Active","Admitted COPD-patient recieving active inhalations",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Chronic obstructive pulmonary disease - Placebo","Admitted COPD-patient recieving placebo inhalations",[19],{"label":29,"type":10,"description":30,"interventionNames":31},"Pulmonal healthy - Active","Admitted pulmonary healthy patient recieving active inhalations",[13],{"label":33,"type":16,"description":34,"interventionNames":35},"Pulmonal healhty - Placebo","Admitted pulmonary healthy patient recieving placebo inhalations",[19],[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Levofloxacin","Add-on treatment of inhaled Levofloxacin 240mg twice daily or placebo (saline) twice daily for up to 3 days while admitted.",[9,21,29],null,{"type":38,"name":44,"description":40,"armGroupLabels":45,"otherNames":42},"Placebo",[15,25,33],[47],{"name":48,"affiliation":49,"role":50},"Jens-Ulrik S. Jensen, Professor, MD, phD","Copenhagen Respiratory Research, Department of Clinical medicine Copenhagen University","STUDY_DIRECTOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":42,"email":56},"Bård-Emil V. Gundersen, Medical Doctor","CONTACT","+45 26193952","baard-emil.vang.gundersen@regionh.dk",{"type":58,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100582141","phase-2-local-antibiotic-delivery-for-community-acquired-pneumonia-100582141",false,"NCT06859450","Local Antibiotic Delivery for Community Acquired Pneumonia","Local Antibiotic Delivery for Community Acquired Pneumonia - Pilot Study (LANDCAP1)","LANDCAP-1","Inclusion Criteria:\n\n1. Hospital admission within 24 hours.\n2. Radiologically new-onset chest infiltrate that is consistent with pneumonia and symptoms or signs also consistent with pneumonia, such as fever, cough, sputum, dyspnoea and\u002For chest pain\n3. CURB-65 score 3-5\n4. C-reactive protein \\>50 OR central body temperature \\>38.0 °C (1-2 of these fulfilled)\n5. Age ≥ 18 years\n6. Able to give informed consent.\n\nExclusion Criteria:\n\n1. Septic shock according to the sepsis III criteria:41 sequential organ failure assessment (SOFA) score ≥2) and suspected infection (according to attending physician) and persisting hypotension requiring vasopressors to maintain MAP≥65 mmHg and serum lactate level\\>2 mmol\u002FL (18 mg\u002FdL) despite adequate volume resuscitation (30 mL\u002Fkg crystalloid within 3 hours).\n2. Oxygen requirement ≥5 L\u002Fmin to maintain acceptable saturation assessed by the treating physician.\n3. Respiratory rate \\>24\u002Fmin with relevant oxygen therapy\n4. Positive COVID or influenza test (PCR or antigen test)\n5. Known allergy to levofloxacin or other fluoroquinolones or a serious adverse reaction when previously treated with a fluoroquinolone, including tendinitis or tendon-rupture related to fluoroquinolone treatment\n6. Symptoms of neuropathy (peripheral paraesthesia, hypoesthesia, or hyperalgesia)\n7. Known allergy to β-lactam antibiotics or to macrolide antibiotics.\n8. Medical history of myasthenia gravis\n9. Reduced kidney function (eGFR \\\u003C 20)\n10. Expected transfer to ICU or death within 48 hours or a do not resuscitate ordination at time of recruitment.\n11. Suspected aspiration pneumonia, pulmonary abscess, or pleural empyema \u002F complicated parapneumonic effusion.\n12. Clinically significant cardiac conduction disorders\u002Farrhythmias or prolonged QTc interval (QTc (f) \\> 480ms).\n13. Pregnancy (a negative pregnancy test is required prior to inclusion of all pre-menopausal women)","ALL","18 Years",{"count":70,"type":71},36,"ESTIMATED","INTERVENTIONAL",[74,75],"PHASE2","PHASE3","A randomized, double-blinded clinical pilot study to assess whether addition of inhaled levofloxacin 240 mg twice daily for three days leads to improved or worsened physiological status in CAP patients with and without pre-existing lung disease.",[78],"Community Acquired Pneumonia (CAP)",[80,81,82,83,84,85,86,87],"Community Acquired Pneumonia","Inhaled levofloxacin","Inhaled antibiotics","feasibility","Chronic obstructive pulmonary disease","asthma","pulmonary healthy","pilot study","NOT_YET_RECRUITING","2025-03-05",{"date":91,"type":92},"2025-03-10","ACTUAL",{"date":94,"type":71},"2025-03-04",{"date":96,"type":71},"2028-09-01",{"name":5,"class":6}]