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临床试验/CTIS2024-511420-13-00
CTIS2024-511420-13-00进行中(未招募)1 期

ocal Antibiotic Delivery for Community Acquired Pneumonia (LANDCAP 2)

Gentofte Hospital0 个研究点目标入组 460 人开始时间: 2024年5月12日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
460

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • Hospital admission within 24 hours., 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/or chest pain., The physician in charge of the patient’s treatment has decided that the patient should be treated with IV piperacillin/tazobactam., C-reactive protein >50 OR central body temperature >38.0o C (1-3 of these fulfilled)., Age = 18 years., Able to give informed consent.

排除标准

  • Septic shock according to the sepsis III criteria; i.e., is organ dysfunction (defined as SOFA=2) due to a dysregulated response to infection as well as persisting hypotension requiring vasopressors to maintain MAP=65 mm Hg and serum lactate level>2 mmol/L (18 mg/dL) despite adequate volume resuscitation., Reduced kidney function (eGFR < 20)., Expected transfer to ICU or death within 48 hours or a do not resuscitate ordination at time of recruitment., Suspected aspiration pneumonia, pulmonary abscess, or pleural empyema / complicated parapneumonic effusion., Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) > 480ms)., Pregnancy (a negative pregnancy test is required prior to inclusion of all pre-menopausal women)., Oxygen requirement =5L/min to maintain 95% saturation., Respiratory rate >24/min with relevant oxygen therapy., Patient meets criteria for addition of macrolide to the antibiotic treatment., Positive COVID or influenza test (PCR or antigen test)., Known allergy to levofloxacin or other fluoroquinolones or a serious adverse reaction when previously treated with a fluoroquinolone., Prior tendinitis or tendon-rupture related to fluoroquinolone treatment., Known allergy to ß-lactam antibiotics., Medical history of myasthenia gravis.

研究者

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