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The study was closed due to slow enrollment.
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Evaluate the safety and outcomes associated between the two treatment modalities
Assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuous infusions (CI) group | Active Comparator | CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge |
|
| Intermittent infusion (II) group | Active Comparator | Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin CI | Drug | The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Nephrotoxicity in Subjects | Number of Subjects with any increase in Serum creatinine by 50% from baseline, an increase in Scr by 0.5 mg/dL, or an increase in Scr by 0.3 mg/dL on two consecutive measurements | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Leukopenia in Subjects | Number of Subjects with White Blood Cell (WBC) < 4,000 x 103 cells/µL | week 8 |
| Number of Infusion-related Reactions | Flushing/Erythema /Rash/Red Man Syndrome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Williamson, PharmD | Wake Forest Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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1 Subject Screen Failed who never received study treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Infusions (CI) Group | continuous infusions (CI) group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin |
| FG001 | Intermittent Infusion (II) Group | Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Infusions (CI) Group | CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Nephrotoxicity in Subjects | Number of Subjects with any increase in Serum creatinine by 50% from baseline, an increase in Scr by 0.5 mg/dL, or an increase in Scr by 0.3 mg/dL on two consecutive measurements | Posted | Count of Participants | Participants | week 8 |
|
up to 21 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Infusions (CI) Group | CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment | an abnormal reduction of circulating white blood cells, especially the granulocytes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Williamson, PhD | Wake Forest University Health Sciences | 336.713.3431 | johnwill@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2020 | Nov 30, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 20, 2021 | Nov 30, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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To assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
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|
| Vancomycin II | Drug | Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge |
|
|
| week 8 |
| Number of Serum Vancomycin Measurements Within Therapeutic Range | Number of Serum Vancomycin Measurements Within Therapeutic Range If inpatient dose was determined by AUC monitoring: A vancomycin trough that is within 3.0 mcg/mL of the trough that correlated with a therapeutic AUC based on inpatient monitoring - If inpatient dose was not determined by AUC monitoring or vancomycin was initiated as outpatient: A vancomycin trough of 10.0 - 20.0 mcg/mL | week 8 |
| Number of Participants With Resolutions of Symptoms Associated With the Infection | Number of Subjects without need for additional induction therapy beyond the planned end date | week 8 |
| Number of Participants With Treatment Failures | Number of Participants with Persistence, new onset, or worsening local or systemic signs and symptoms of infection | week 21 |
| BG001 | Intermittent Infusion (II) Group | Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
|
|
| Secondary | Number of Leukopenia in Subjects | Number of Subjects with White Blood Cell (WBC) < 4,000 x 103 cells/µL | Posted | Count of Participants | Participants | week 8 |
|
|
|
| Secondary | Number of Infusion-related Reactions | Flushing/Erythema /Rash/Red Man Syndrome | Posted | Count of Participants | Participants | week 8 |
|
|
|
| Secondary | Number of Serum Vancomycin Measurements Within Therapeutic Range | Number of Serum Vancomycin Measurements Within Therapeutic Range If inpatient dose was determined by AUC monitoring: A vancomycin trough that is within 3.0 mcg/mL of the trough that correlated with a therapeutic AUC based on inpatient monitoring - If inpatient dose was not determined by AUC monitoring or vancomycin was initiated as outpatient: A vancomycin trough of 10.0 - 20.0 mcg/mL | Posted | Number | Number of Blood Draws | week 8 | Number of blood draws | Number of blood draws |
|
|
|
| Secondary | Number of Participants With Resolutions of Symptoms Associated With the Infection | Number of Subjects without need for additional induction therapy beyond the planned end date | Posted | Count of Participants | Participants | week 8 |
|
|
|
| Secondary | Number of Participants With Treatment Failures | Number of Participants with Persistence, new onset, or worsening local or systemic signs and symptoms of infection | Posted | Count of Participants | Participants | week 21 |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Intermittent Infusion (II) Group | Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge | 0 | 3 | 0 | 3 | 1 | 3 |
|
| hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| nephrotoxicity | Renal and urinary disorders | Non-systematic Assessment | kidneys are damaged by a drug, chemical or toxin, resulting in possible chronic kidney disease. |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |