None listed
Conditions
Interventions
Drug : Only patients who be provided written informed consent by their own self or patient's legally authorized representative undergo screening assessment prior to the first PK sampling day to determ
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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 ? myeloma ? cystic fibrosis or active pulmonary tuberculosis ? lung transplant recipient or donor ? burn injury on more than 20 % of the body surface 11) Any other major illness that, in the investigator's judgment, may interfere with the study objectives. 12) Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the patient's participation/completion in this study. 13) Any other factor that, in the investigator's judgment, inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C_max of vancomycin;C_trough of vancomycin;AUC_tau of vancomycin;C_ELF of vancomycin | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma biomarkers of nephrotoxicity;Urinary biomarkers of nephrotoxicity | — |
Countries
Korea, Republic of
Contacts
Public ContactSooyoung Lee
Kyung Hee University Hospital
Outcome results
None listed