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Trial record 23 of 530 for:    VANCOMYCIN

Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens

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ClinicalTrials.gov Identifier: NCT02764359
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
William Payne, CAMC Health System

Brief Summary:

Obesity alters the movement through the body of several antibiotics, including vancomycin. Based on literature to date, total body weight should be used to determine dosages and shorter dosing intervals may be needed. However, hospitals have different approaches to managing vancomycin in this patient population. The most common example is not exceeding a dose of 2,000mg of vancomycin at one time in these patients. However, some institutions including the Charleston Area Medical Center do not have a set maximum one time dose. To date, a study has not been done comparing two different dosing regimens in obese patients to determine if having a maximum dose cap is beneficial.

This research study is attempting to add to the limited existing body of literature regarding vancomycin dosing in obese patients. The investigators hypothesize that optimizing the initial or loading vancomycin dose that obese patients receive will decrease the time to target concentrations. For this study, obese adult patients will be randomized to receive either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg OR 2) a loading dose of 20 mg/kg with a maximum dose of up to 4,000mg. The study's primary aim is to determine differences in the time needed to achieve target vancomycin concentrations and the occurrence of adverse events.


Condition or disease Intervention/treatment Phase
Infection Sepsis Obesity Drug: IV vancomycin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-Center Prospective Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV Vancomycin loading dose- higher
IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 4,000mg
Drug: IV vancomycin
IV vancomycin for the treatment of infection. Following the vancomycin loading dose, vancomycin dosing will be at the discretion of the pharmacist and attending physician and will follow standard of care.

Experimental: IV Vancomycin loading dose- lower
IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 2,000mg
Drug: IV vancomycin
IV vancomycin for the treatment of infection. Following the vancomycin loading dose, vancomycin dosing will be at the discretion of the pharmacist and attending physician and will follow standard of care.




Primary Outcome Measures :
  1. Time to attain therapeutic vancomycin concentrations [ Time Frame: < 7 days ]

Secondary Outcome Measures :
  1. Reported adverse events [ Time Frame: 48 hours post initial vancomycin dose ]

    Red Man's syndrome: pruritus and erythematous rash involving the face, neck, and upper torso.

    Nephrotoxicity: increase in serum creatinine (SCr) by 0.5 mg/dL or 50% from baseline on two consecutive measurements.


  2. Examine the pharmacokinetic parameter of elimination rate constant (ke) following the loading vancomycin dose [ Time Frame: 12 hours ]
  3. Examine the pharmacokinetic parameter of volume of distribution (Vd) following the loading vancomycin dose [ Time Frame: 12 hours ]
  4. Intensive care unit length of stay [ Time Frame: 30 days ]
  5. Hospital length of stay [ Time Frame: 30 days ]
  6. In-hospital mortality [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥18 years of age who present to the Charleston Area Medical Center-Memorial Hospital Emergency Department
  • Weight >100kg
  • Infection requiring intravenous vancomycin and admission to Charleston Area Medical Center-Memorial Hospital

Exclusion Criteria:

  • Any patient <18 years of age
  • Patients on dialysis or with unstable renal function (a change of >0.5 mg/dL in SCr concentration in patients with a SCr of <2 mg/dL or a 20% change in SCr in patients with a SCr of ≥2 mg/dL)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764359


Contacts
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Contact: William Payne, MD 304-388-6004 Murnau@aol.com
Contact: Adam Crawford, DO 304-388-6004 acrawford@osteo.wvsom.edu

Locations
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United States, West Virginia
CAMC Health Systems Recruiting
Charleston, West Virginia, United States, 25304
Contact: William Payne, MD    304-388-6004    Murnau@aol.com   
Contact: Adam Crawford, DO    304-388-6004    acrawford@osteo.wvsom.edu   
Principal Investigator: William Payne, MD         
Sub-Investigator: Adam Crawford, DO         
Sponsors and Collaborators
CAMC Health System

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Responsible Party: William Payne, Emergency Medicine Physician, CAMC Health System
ClinicalTrials.gov Identifier: NCT02764359     History of Changes
Other Study ID Numbers: 15-120
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents