Status Approved
First Submitted Date
2020/12/15
Registered Date
2020/12/31
Last Updated Date
2021/12/02
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005729 |
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Unique Protocol ID | KH-VANC-03 |
Public/Brief Title | A clinical study to evaluate the intrapulmonary pharmacokinetics of vancomycin and to explore biomarkers for nephrotoxicity in critically ill patients with pneumonia |
Scientific Title | A clinical study to evaluate the intrapulmonary pharmacokinetics of vancomycin and to explore biomarkers for nephrotoxicity in critically ill patients with pneumonia |
Acronym | KH-VANC-03 |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Submitted pending |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | KHUH 2020-11-006-003 |
Approval Date | 2020-12-15 |
Institutional Review Board Name | Kyung Hee University Hospital Institutional Review Board Membership |
Institutional Review Board Address | 23, Kyungheedae-ro, Dongdaemun-gu, Seoul |
Institutional Review Board Telephone | 02-958-9579 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Bo-Hyung Kim |
Title | professor |
Telephone | +82-2-958-2913 |
Affiliation | Kyung Hee University Hospital |
Address | 23, Kyungheedae-ro, Dongdaemun-gu, Seoul |
Contact Person for Public Queries | |
Name | Sooyoung Lee |
Title | Researcher |
Telephone | +82-2-961-2269 |
Affiliation | Kyung Hee University Hospital |
Address | 23, Kyungheedae-ro, Dongdaemun-gu, Seoul |
Contact Person for Updating Information | |
Name | Sooyoung Lee |
Title | Researcher |
Telephone | +82-2-961-2269 |
Affiliation | Kyung Hee University Hospital |
Address | 23, Kyungheedae-ro, Dongdaemun-gu, Seoul |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-04-01 Actual | |
Target Number of Participant | 24 | |
Primary Completion Date | 2022-09-01 , Anticipated | |
Study Completion Date | 2022-11-11 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Kyung Hee University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-04-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | National Research Foundation |
Organization Type | Government |
Project ID | 2019R1C1C1011218 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kyung Hee University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | It is necessary to study producing pharmacokinetic parameters for appropriately therapeutic drug monitoring. Successful treatment of infectious disease needs to understand the delivery of antibiotics to the area of infection. However, there are very few studies of vancomycin intrapulmonary pharmacokinetic study of pneumonia patients with the pulmonary area of infection. So, we will investigate the intrapulmonary pharmacokinetic study in Korean patients. And, we will also investigate the suitable biomarkers to predict the nephrotoxicity with vancomycin administration. When the vancomycin is used on seriously infectious patients who cannot use other antibiotics because of resistances or adverse events, nephrotoxicity can be a serious problem that drug discontinuation should be taken into consideration. Therefore, We will investigate the nephrotoxicity with novel nephrotoxicity biomarkers. By investigating like this pharmacokinetic and biomarkers exploring, if the suitable pharmacokinetic parameters and biomarkers for vancomycin in Korean patients will be produced, it is expected to improve the successful treatment of patients. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase1 |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Non-RCT |
Intervention Type | Drug |
Intervention Description | 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 determine their eligibility for enrollment into the study. Subjects who enrolled will be conducted first PK sampling within 7 days from informed consent, that day names day 1, and that day administration names PK administration. The vancomycin will be administered by intravenous infusion. But, The infusion time is 1 hour. The dosage will be determined by TDM or clinician's opinion based on 'The Sanford guide to antimicrobial therapy(熱病)'. By planned study schedules, Blood sampling is conducted for pharmacokinetic assessments, BAL is conducted for BALF collection at only 1 point by each subject. From day 2, PK blood sampling is conducted only when TDM is conducted, and BALF is collected only when BAL is conducted. For the evaluation of nephrotoxicity biomarkers, blood sampling is conducted at 1~7 days and urine sampling is conducted at 1, 4 days. On the 7th day from the first PK sampling, the study is complete. |
Number of Arms | 1 |
Arm 1 |
Arm Label Experimental arm |
Target Number of Participant 24 |
|
Arm Type Experimental |
|
Arm Description Subjects will be conducted first PK sampling within 7 days from informed consent, that day names day 1, and that day administration names PK administration. The vancomycin will be administered by intravenous infusion. But, The infusion time is 1 hour. The dosage will be determined by TDM or clinician's opinion based on 'The Sanford guide to antimicrobial therapy(熱病)'. By planned study schedules, Blood sampling is conducted for pharmacokinetic assessments, BAL is conducted for BALF collection at only 1 point by each subject. From day 2, PK blood sampling is conducted only when TDM is conducted, and BALF is collected only when BAL is conducted. For the evaluation of nephrotoxicity biomarkers, blood sampling is conducted at 1~7 days and urine sampling is conducted at 1, 4 days. On the 7th day from the first PK sampling, the study is complete. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (J00-J99)Diseases of the respiratory system (J18.9)Pneumonia, unspecified suspicion or diagnosis of pneumonia |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~No Limit |
|
Description 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 ① myeloma ② cystic fibrosis or active pulmonary tuberculosis ③ lung transplant recipient or donor ④ 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. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | &Pharmacokinetics/dynamics | |
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Primary Outcome(s) 1 | ||
Outcome | C_max of vancomycin |
|
Timepoint | Day 1 |
|
Primary Outcome(s) 2 | ||
Outcome | C_trough of vancomycin |
|
Timepoint | Day 1, Day 1~7 (when TDM) |
|
Primary Outcome(s) 3 | ||
Outcome | AUC_tau of vancomycin |
|
Timepoint | Day 1 |
|
Primary Outcome(s) 4 | ||
Outcome | C_ELF of vancomycin |
|
Timepoint | Day 1, Day 2~7 (when BAL) |
|
Secondary Outcome(s) 1 | ||
Outcome | Plasma biomarkers of nephrotoxicity |
|
Timepoint | Day 1~7 |
|
Secondary Outcome(s) 2 | ||
Outcome | Urinary biomarkers of nephrotoxicity |
|
Timepoint | Day 1, Day 4 |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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