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Local Antibiotic Delivery for Community Acquired Pneumonia - Pilot study (LANDCAP1)
EU CTIS ID: 2024-511413-37-00
What this study is testing
The objective of this study is to determine if addition of inhaled levofloxacin 240 mg twice daily for three days leads to improved or worsened physiological or infectious status in CAP patients with and without pre-existing lung disease.
- 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
- C-reactive protein >50 OR central body temperature >38.0 °C (1-2 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: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).
- 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 ≥5 L/min to maintain acceptable saturation assessed by the treating physician.
- Respiratory rate >24/min with relevant oxygen therapy
See the full eligibility 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
- C-reactive protein >50 OR central body temperature >38.0 °C (1-2 of these fulfilled)
- Age ≥ 18 years
- Able to give informed consent
- 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).
- 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 ≥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
- Unexplained symptoms of neuropathy (peripheral paraesthesia, hypoesthesia, or hyperalgesia)
- Medical history of myasthenia gravis
- Reduced kidney function (eGFR < 20)
- A clinical state where the physician believes that chance of survival for 48 hours at time of recruitment is minimal.
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.
Explore other conditions
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.