Local Antibiotic Delivery for Community Acquired Pneumonia

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCopenhagen Respiratory Research

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Levofloxacin
  • Placebo

Treatment groups

36 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

This trial has no locations