CTIS2024-511413-37-00
Active, not recruiting
Phase 1
ocal Antibiotic Delivery for Community Acquired Pneumonia - Pilot study (LANDCAP1)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Gentofte Hospital
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)., 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 \=5 L/min to maintain 95% saturation., 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 ß\-lactam antibiotics or to macrolide antibiotics., Medical history of myasthenia gravis, Reduced kidney function (eGFR \< 20\)
Outcomes
Primary Outcomes
Not specified
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ocal Antibiotic Delivery for Community Acquired Pneumonia (LANDCAP 2)Community-acquired pneumoniaTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]CTIS2024-511420-13-00Gentofte Hospital460
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