Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT06859450
Eligibility Criteria:
Inclusion Criteria:
1. Hospital admission within 24 hours.
2. 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
3. CURB-65 score 3-5
4. C-reactive protein \>50 OR central body temperature \>38.0 °C (1-2 of these fulfilled)
5. Age ≥ 18 years
6. Able to give informed consent.
Exclusion Criteria:
1. 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).
2. Oxygen requirement ≥5 L/min to maintain acceptable saturation assessed by the treating physician.
3. Respiratory rate \>24/min with relevant oxygen therapy
4. Positive COVID or influenza test (PCR or antigen test)
5. 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
6. Symptoms of neuropathy (peripheral paraesthesia, hypoesthesia, or hyperalgesia)
7. Known allergy to β-lactam antibiotics or to macrolide antibiotics.
8. Medical history of myasthenia gravis
9. Reduced kidney function (eGFR \< 20)
10. Expected transfer to ICU or death within 48 hours or a do not resuscitate ordination at time of recruitment.
11. Suspected aspiration pneumonia, pulmonary abscess, or pleural empyema / complicated parapneumonic effusion.
12. Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) \> 480ms).
13. Pregnancy (a negative pregnancy test is required prior to inclusion of all pre-menopausal women)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06859450
Study Brief:
Protocol Section:
NCT06859450