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.
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)
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).
Oxygen requirement ≥5 L/min to maintain acceptable saturation assessed by the treating physician.
Respiratory rate >24/min with relevant oxygen therapy
Positive COVID or influenza test (PCR or antigen test)
Parallel
Levofloxacin
DrugAdd-on treatment of inhaled Levofloxacin 240mg twice daily or placebo (saline) twice daily for up to 3 days while admitted.
Placebo
DrugAdd-on treatment of inhaled Levofloxacin 240mg twice daily or placebo (saline) twice daily for up to 3 days while admitted.
6
Treatment groupsSee each treatment group below.
Change in FEV1 after first inhalation from baseline
Proportion of patients with a drop in FEV1 of 20% or 300mL one hour following the first inhalation.
Change in FEV1 from baseline to day 4 or discharge
Proportion of patients with a drop in FEV1 of 20% or 300mL from baseline to day 4 or discharge, whichever comes first.
C-reactive protein (CRP) on day 4 higher than any day from baseline to day 3.
CRP on day 4 higher than on any day from 1 to 3 including baseline.
Physiological status at day 4
Mean Arterial Pressure ≤ 65 OR respiratory frequency \> 25 OR pulse \> 100 OR needing supplemental oxygen (1-4 of these fulfilled) on day 4.
Procalcitonin day 4 compared to any day before including baseline
Procalcitonin on day 4 higher than on any day from 1 to 3 including baseline.
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