Not Yet RecruitingPhase 2/3

Local Antibiotic Delivery for Community Acquired Pneumonia

36 participantsStarted 2025-03-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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).
✕. 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)
✕. 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 β-lactam antibiotics or to macrolide antibiotics.
✕. Medical history of myasthenia gravis

What they're measuring

Change in FEV1 after first inhalation from baseline

Timeframe: Enrollment to second assessment - 1 hour

Trial details

NCT IDNCT06859450

SponsorCopenhagen Respiratory Research

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-09-01

Contact for this trial

Bård-Emil V. Gundersen, Medical Doctor

+45 26193952 baard-emil.vang.gundersen@regionh.dk

View on ClinicalTrials.gov More Community Acquired Pneumonia (CAP) trials