Vancomycin Clinical Trial
Official title:
A Randomized Clinical Trial of Continuous vs. Intermittent Infusion Vancomycin: Effects on Measured GFR and Kidney Injury Biomarkers
Hospitalized adult participants prescribed vancomycin by their treating physician will be randomized to receive vancomycin via continuous or intermittent infusion and measures of kidney function and injury will be collected.
All study participants regardless of participation status will have been prescribed vancomycin by a treating physician and received a dose per institutional standard of care. Participants will be randomized 1:1 in permuted blocks of 2, 4, or 6 to receive subsequent doses via continuous or intermittent infusion. Participants randomized to intermittent infusion will receive doses per standard of care at infusion rates of 1 gram per hour in every 8,-12, or -24 hour intervals, while participants randomized to continuous infusion will receive a total daily dose infused over a period of 24 hours. Vancomycin concentration will not exceed 5mg/ml and will be infused via central (preferred) or peripheral administration. In order to ensure consistent dosing between study arms, a precision dosing platform will be used by the PI and team to determine total daily doses to best target an AUC of 500 mg x hr/L (range 400-600 mg x hr/L). A single vancomycin concentration will be obtained the following day with Bayesian-guided area-under-the-curve (AUC) monitoring (with dosing adjusted if needed) to ensure vancomycin exposure remains similar between infusion strategies. Both the initiation and discontinuation of vancomycin, as well as any additional therapeutic drug monitoring, will remain at the discretion of the primary clinical team. Glomerular filtration rate (GFR) will be measured on the day of enrollment and day 3 by the administration of 5 ml iohexol (300 mgI/ml) with iohexol plasma concentrations obtained 1 and 4 hours following administration of iohexol. This change in measured GFR between the infusion strategies is the primary outcome of the study. Plasma and urinary markers of kidney function and injury will be obtained the day of enrollment (Day 0) and subsequent days (Days 2-3). If the participant remains on vancomycin 120 hours following enrollment, measured glomerular filtration rate (mGFR) and biomarkers will be assessed again. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03221023 -
Intrawound Vancomycin Prophylaxis for Neural Stimulator
|
Phase 2/Phase 3 | |
Recruiting |
NCT03456544 -
Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China
|
||
Not yet recruiting |
NCT05964114 -
First Time Right of Vancomycin
|
N/A | |
Completed |
NCT02951702 -
Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
|
Phase 4 | |
Completed |
NCT05535075 -
Model-informed Precision Dosing of Vancomycin in Adults
|
Phase 4 | |
Active, not recruiting |
NCT04911270 -
Clinical Decision Support Tool for Vancomycin Dosing in Children
|
N/A | |
Recruiting |
NCT02456974 -
Antibiotic Dosing in Pediatric Intensive Care
|
||
Recruiting |
NCT05257070 -
The Clinical Validation of a Dried Blood Spot Method for Vancomycin and Creatinine
|
||
Enrolling by invitation |
NCT03585426 -
Vancomycin in the Target Site Treatment of Intracranial Infection
|
Phase 4 | |
Completed |
NCT04756895 -
Vancomycin Dose Adjustments Comparing Trough Levels to The AUC/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population
|
N/A | |
Suspended |
NCT02590523 -
Intracameral Antibiotic Safety Study
|
Phase 3 | |
Completed |
NCT03806543 -
The Influencing Factors of Vancomycin Trough Level and the Rate Achieving the Target Trough Level
|
||
Recruiting |
NCT04758442 -
Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology
|
N/A | |
Completed |
NCT04042233 -
Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
|
Phase 4 | |
Active, not recruiting |
NCT04666948 -
Precision Dosing of Vancomycin in Critically Ill Children
|
Phase 4 | |
Recruiting |
NCT02667418 -
Optimal Treatment for Recurrent Clostridium Difficile
|
Phase 4 | |
Recruiting |
NCT06069206 -
Effect of Direct-from-blood Bacterial Testing on Antibiotic Administration and Clinical Outcomes
|
N/A | |
Completed |
NCT03453684 -
Pharmacokinetics of Preoperative Vancomycin
|
Phase 4 | |
Recruiting |
NCT06426836 -
Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)
|
N/A |