ocal Antibiotic Delivery for Community Acquired Pneumonia (LANDCAP 2)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 460

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine whether treatment with inhaled levofloxacin 240 mg twice daily and no systemic antibiotics for 4-5 days is non-inferior as measured by days alive and out of hospital within 14 days compared to intravenous piperacillin/tazobactam.;Secondary Objective: To reduce proportion of patients with antibiotic side-effects, To preserve diversity in the gut microbiome following treatment, To examine whether inhaled levofloxacin is non-inferior on 30-day all-cause mortality., To examine whether inhaled levofloxacin is non-inferior as measured by readmission, intensive care transfers or death within 30 days., To examine whether inhaled levofloxacin is non-inferior on biochemical and vital parameters (blood pressure, tenperature, peripheral oxygen saturation), To examine whether inhaled levofloxacin is non-inferior on patient-reported outcomes;Primary end point(s): Days alive and out of hospital at 14 days.

Secondary Outcome Measures