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Clinical Trials/CTIS2024-511413-37-00
CTIS2024-511413-37-00
Active, not recruiting
Phase 1

ocal Antibiotic Delivery for Community Acquired Pneumonia - Pilot study (LANDCAP1)

Gentofte Hospital0 sites36 target enrollmentApril 14, 2024

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.

Registry
who.int
Start Date
April 14, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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