Authorised Therapeutic exploratory (Phase II) Community-acquired pneumonia

Local Antibiotic Delivery for Community Acquired Pneumonia (LANDCAP 2)

EU CTIS ID: 2024-511420-13-00

What this study is testing

To examine whether treatment with inhaled levofloxacin 240 mg twice daily and no systemic antibiotics for 4-5 days is non-inferior as measured by days alive and out of hospital within 14 days compared to intravenous piperacillin/tazobactam.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.
  • The physician in charge of the patient’s treatment has decided that the patient should be treated with IV piperacillin/tazobactam.
  • C-reactive protein >50 OR central body temperature >38.0o C (1-3 of these fulfilled).
  • Age ≥ 18 years.
  • Able to give informed consent.

You likely can't join if

  • Septic shock according to the sepsis III criteria; i.e., is organ dysfunction (defined as SOFA≥2) due to a dysregulated response to infection as well as persisting hypotension requiring vasopressors to maintain MAP≥65 mm Hg and serum lactate level>2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
  • Reduced kidney function (eGFR < 20).
  • 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.
  • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) > 480ms).
  • Pregnancy (a negative pregnancy test is required prior to inclusion of all pre-menopausal women).
See the full eligibility criteria
Who can join
  • 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.
  • The physician in charge of the patient’s treatment has decided that the patient should be treated with IV piperacillin/tazobactam.
  • C-reactive protein >50 OR central body temperature >38.0o C (1-3 of these fulfilled).
  • Age ≥ 18 years.
  • Able to give informed consent.
What rules you out
  • Septic shock according to the sepsis III criteria; i.e., is organ dysfunction (defined as SOFA≥2) due to a dysregulated response to infection as well as persisting hypotension requiring vasopressors to maintain MAP≥65 mm Hg and serum lactate level>2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
  • Reduced kidney function (eGFR < 20).
  • 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.
  • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) > 480ms).
  • Pregnancy (a negative pregnancy test is required prior to inclusion of all pre-menopausal women).
  • Oxygen requirement ≥5L/min to maintain 95% saturation.
  • Respiratory rate >24/min with relevant oxygen therapy.
  • Patient meets criteria for addition of macrolide to the antibiotic treatment.
  • 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.
  • Prior tendinitis or tendon-rupture related to fluoroquinolone treatment.
  • Known allergy to β-lactam antibiotics.
  • Medical history of myasthenia gravis.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.