CTIS2024-511420-13-00
Active, not recruiting
Phase 1
ocal Antibiotic Delivery for Community Acquired Pneumonia (LANDCAP 2)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Community-acquired pneumonia
- Sponsor
- Gentofte Hospital
- Enrollment
- 460
- 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., 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.
Exclusion Criteria
- •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 ß\-lactam antibiotics., Medical history of myasthenia gravis.
Outcomes
Primary Outcomes
Not specified
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ocal Antibiotic Delivery for Community Acquired Pneumonia - Pilot study (LANDCAP1)CTIS2024-511413-37-00Gentofte Hospital36
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