Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens

NCT02764359 | Completed Results

• 1 other identifier: 15-120
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Sepsis; Obesity

Outcome Measures

Primary Outcomes (1)

• Time to Attain Therapeutic Vancomycin Concentrations.

  Time to attain therapeutic vancomycin concentrations was measured in hours. Therapeutic vancomycin concentrations were set as 15-20 mg/L in patients with serious, documented Gram-positive infections (e.g., endocarditis, meningitis, pneumonia, osteomyelitis), while in patients with a lower risk of Gram-positive infections (e.g., pyelonephritis, skin/tissue structured infections), therapeutic vancomycin concentrations were defined as 10-15 mg/L.

  Time Frame: 20 days

Secondary Outcomes (5)

• Number of Participants With Reported Adverse Events (AE)

  48 hours post initial vancomycin dose

• Examine the Pharmacokinetic Parameter of Elimination Rate Constant (ke) Following the Loading Vancomycin Dose

  12 hours

• Intensive Care Unit Length of Stay

  30 days

• Hospital Length of Stay

  60 days

• In-hospital Mortality

  60 days

Study Arms (2)

IV Vancomycin loading dose- higher

EXPERIMENTAL

IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 4,000mg

Drug: IV vancomycin

IV Vancomycin loading dose- lower

EXPERIMENTAL

IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 2,000mg

Drug: IV vancomycin

Interventions

IV vancomycin DRUG

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.

IV Vancomycin loading dose- higher; IV Vancomycin loading dose- lower

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

CAMC Health Systems

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Infections; Sepsis; Obesity

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Limitations include the single-center design and exclusion of patients with unstable renal function, which may limit generalizability. The study period's overlap with COVID-19 may have affected patient demographics and protocols, leading to variability in vancomycin level timing. Not all confounders, such as other medications, were analyzed. Lastly, randomization was limited to the initial vancomycin dose, with further doses determined by the admitting physician.

Results Point of Contact

• Title: Dr. Stephanie Thompson
• Organization: CAMC

stephanie.thompson2@vandaliahealth.org

3043889911

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 6, 2016
• Study Start: August 1, 2016
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 1, 2026
• Results First Posted: October 1, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)