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NCT06859450Not yet recruitingPhase 2/3

Local Antibiotic Delivery for Community Acquired Pneumonia

Local Antibiotic Delivery for Community Acquired Pneumonia - Pilot Study (LANDCAP1)

Source: ClinicalTrials.gov · Last updated 10 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
36 (estimated)
First submitted
28 Feb 2025
Start date
4 Mar 2025
Primary completion date
1 Sept 2025
Lead sponsor
Copenhagen Respiratory Research
Diseases
Asthma, COPD
NCT number
NCT06859450
EU CT number
2024-511413-37-00

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 36
  • From 4 Mar 2025 to the primary completion date, 1 Sept 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Respiratory rate \>24/min with relevant oxygen therapy
  • 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
  • Pregnancy (a negative pregnancy test is required prior to inclusion of all pre-menopausal women)

Other illness

  • Positive COVID or influenza test (PCR or antigen test)
  • Known allergy to β-lactam antibiotics or to macrolide antibiotics.
  • Medical history of myasthenia gravis

Lab values

  • 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).
  • Reduced kidney function (eGFR \< 20)
  • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) \> 480ms).

Other

  • Oxygen requirement ≥5 L/min to maintain acceptable saturation assessed by the treating physician.
  • Symptoms of neuropathy (peripheral paraesthesia, hypoesthesia, or hyperalgesia)
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.