KCT0005729
Recruiting
未知
A clinical study to evaluate the intrapulmonary pharmacokinetics of vancomycin and to explore biomarkers for nephrotoxicity in critically ill patients with pneumonia
Kyung Hee University Hospital0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kyung Hee University Hospital
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) 19 years of age or older
- •2\) Patient has provided written informed consent or informed consent has been provided by the patient's legally authorized representative
- •3\) Patient has a suitability for the administration of vancomycin as a clinical manifestation
- •4\) Patient has suspicion or diagnosis of bacterial pneumonia
- •5\) Patient has a requirement for the collection of BALF for diagnosis/treatment
Exclusion Criteria
- •1\) Patient has a history of any shock or hypersensitivity against the investigational product or aminoglycoside antibiotics
- •2\) Patient has contraindications and/or precautions to investigational product (who have an underlying hearing loss, who are receiving concomitant therapy with another ototoxic agent, such as aminoglycosides or peptide antibiotics, who have vestibular and/or cochlear injury)
- •3\) Imminent death within 48 hours
- •4\) Pregnant or breastfeeding women
- •5\) Patients has contraindications to bronchoalveolar lavage
- •6\) Patients has hypersensitivity to medications associated with the bronchoalveolar lavage procedures, such as local anesthetics, sedatives, pain control medications
- •7\) Patient has a requirement for extracorporeal membrane oxygenation(ECMO) therapy
- •8\) Patient has a requirement for renal replacement therapy
- •9\) Patient has renal insufficiency as evidenced by an estimated creatinine clearance \<50 mL/min based on the Cockcroft\-Gault formula
- •10\) Patient has comorbidities influencing vancomycin pharmacokinetics as the following
Outcomes
Primary Outcomes
Not specified
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