ocal Antibiotic Delivery for Community Acquired Pneumonia - Pilot study (LANDCAP1)

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Community-acquired pneumonia; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2024-511413-37-00
• Lead Sponsor: Gentofte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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, CURB-65 score 3-5, C-reactive protein >50 OR central body temperature >38.0 °C (1-2 of these fulfilled), Age = 18 years, Able to give informed consent

Exclusion Criteria

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/L (18 mg/dL) despite adequate volume resuscitation (30 mL/kg crystalloid within 3 hours)., 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 =5 L/min to maintain 95% saturation., Respiratory rate >24/min with relevant oxygen therapy, 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, including tendinitis or tendon-rupture related to fluoroquinolone treatment, Symptoms of neuropathy (peripheral paraesthesia, hypoesthesia, or hyperalgesia), Known allergy to ß-lactam antibiotics or to macrolide antibiotics., Medical history of myasthenia gravis, Reduced kidney function (eGFR < 20)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified