NCT02764359Completed
Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens
Single-Center Prospective Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 2 May 2016
- Start date
- 1 Aug 2016
- Primary completion date
- 1 Apr 2024
- Lead sponsor
- CAMC Health System
- Diseases
- Obesity
- NCT number
- NCT02764359
What you commit to
- Study type: Interventional
- Participants enrolled: 76
- From 1 Aug 2016 to the primary completion date, 1 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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)
Age
- Any patient \<18 years of age
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CAMC Health Systems Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.