Local Antibiotic Delivery for Community Acquired Pneumonia

Launched by COPENHAGEN RESPIRATORY RESEARCH · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver antibiotics to patients with community-acquired pneumonia (CAP), which is a type of lung infection that people can get outside of a hospital. The researchers want to find out if inhaling a specific antibiotic called levofloxacin, twice a day for three days, can help improve the health of patients with pneumonia, especially those who might already have lung issues.

To be eligible for this trial, participants need to be adults aged 18 or older who have been admitted to the hospital within the last 24 hours and have signs of pneumonia, like a cough, fever, or difficulty breathing. They also need to have a specific score that indicates the severity of their pneumonia. However, there are some exclusions, such as those with severe respiratory problems or certain allergies. If someone joins the trial, they will receive either the inhaled antibiotic or a placebo (a non-active treatment), and both the participants and researchers won’t know which one they’re getting to ensure the study is fair. This trial is not yet recruiting participants, but it aims to find better treatment options for pneumonia, which could help many patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Hospital admission within 24 hours.
• • 2. 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
• • 3. CURB-65 score 3-5
• • 4. C-reactive protein \>50 OR central body temperature \>38.0 °C (1-2 of these fulfilled)
• • 5. Age ≥ 18 years
• • 6. Able to give informed consent.
• Exclusion Criteria:
• • 1. 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).
• • 2. Oxygen requirement ≥5 L/min to maintain acceptable saturation assessed by the treating physician.
• • 3. Respiratory rate \>24/min with relevant oxygen therapy
• • 4. Positive COVID or influenza test (PCR or antigen test)
• • 5. 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
• • 6. Symptoms of neuropathy (peripheral paraesthesia, hypoesthesia, or hyperalgesia)
• • 7. Known allergy to β-lactam antibiotics or to macrolide antibiotics.
• • 8. Medical history of myasthenia gravis
• • 9. Reduced kidney function (eGFR \< 20)
• • 10. Expected transfer to ICU or death within 48 hours or a do not resuscitate ordination at time of recruitment.
• • 11. Suspected aspiration pneumonia, pulmonary abscess, or pleural empyema / complicated parapneumonic effusion.
• • 12. Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) \> 480ms).
• • 13. Pregnancy (a negative pregnancy test is required prior to inclusion of all pre-menopausal women)