InfectionNCT02764359

Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens

A study testing IV vancomycin in people with Infection and Sepsis, run by CAMC Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Infection, Sepsis, Obesity
What is being tested?: IV vancomycin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2016to 1 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

CAMC Health Systems
Charleston, West Virginia, 25304

Other trials in United States

About this study

Official title: Single-Center Prospective Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens

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
Being tested: IV vancomycin
Medical subject headings: Infections, Sepsis, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IV vancomycinDrug
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.

Study groups in NCT02764359
Study group	Role	What they receive
IV Vancomycin loading dose- higher	Experimental	IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 4,000mg Receives: Drug: IV vancomycin
IV Vancomycin loading dose- lower	Experimental	IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 2,000mg Receives: Drug: IV vancomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Time Frame: 20 days

Secondary outcomes (5)

Number of Participants With Reported Adverse Events (AE)
Red Man's syndrome: pruritus and erythematous rash involving the face, neck, and upper torso. Red Man's syndrome is an older term for vancomycin flushing syndrome (VFS).
Nephrotoxicity: increase in serum creatinine (SCr) by 0.5 mg/dL or 50% from baseline on two consecutive measurements.
Measured: 48 hours post initial vancomycin dose
Examine the Pharmacokinetic Parameter of Elimination Rate Constant (ke) Following the Loading Vancomycin Dose
These measurements assessed the elimination rate constant of vancomycin between the two treatment regimens. Two elimination rate constants were assessed: Elimination constant at 7.5-hour trough level and Elimination constant at initial trough level.
Measured: 12 hours
Intensive Care Unit Length of Stay
The duration of time participants spent in the intensive care unit (ICU) during their hospitalization. This outcome measures the total number of days spent in the ICU, from ICU admission to discharge from ICU.
Measured: 30 days
Hospital Length of Stay
The total duration of hospitalization, measured from the time of hospital admission to discharge.
Measured: 60 days
In-hospital Mortality
The percentage of participants that died during their hospital stay. This measure assesses the mortality rate from the time of hospital admission until discharge or death.
Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20161 Apr 2024

First posted6 May 2016 (estimated)
Study start1 Aug 2016
Primary completion1 Apr 2024
Study completion1 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02764359
Sponsor's protocol ID: 15-120
Status last verified: Oct 2024
First submitted: 2 May 2016
Last updated: 1 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-Center Prospective Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens
ClinicalTrials.gov ID: NCT02764359
Acronym / sponsor ID: 15-120
Conditions: Infection, Sepsis, Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: CAMC Health SystemUniversity, hospital or other
Study start: 1 Aug 2016 (actual)
Primary completion: 1 Apr 2024 (actual)
Study completion: 1 Apr 2024 (actual)
First posted: 6 May 2016 (estimated)
Results: Posted 1 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IV Vancomycin loading dose- higher	Experimental	Drug: IV vancomycinIV Vancomycin loading dose: 20 mg/kg with a maximum dose of 4,000mg
IV Vancomycin loading dose- lower	Experimental	Drug: IV vancomycinIV Vancomycin loading dose: 20 mg/kg with a maximum dose of 2,000mg

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IV vancomycinIV 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.	Drug	IV Vancomycin loading dose- higher, IV Vancomycin loading dose- lower

Primary outcome

Time to Attain Therapeutic Vancomycin Concentrations.
Time frame: Time Frame: 20 days
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.

5 secondary outcomes

Number of Participants With Reported Adverse Events (AE)
Time frame: 48 hours post initial vancomycin dose
Examine the Pharmacokinetic Parameter of Elimination Rate Constant (ke) Following the Loading Vancomycin Dose
Time frame: 12 hours
Intensive Care Unit Length of Stay
Time frame: 30 days
Hospital Length of Stay
Time frame: 60 days
In-hospital Mortality
Time frame: 60 days

Results and safety

Results posted to the registry on 1 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IV Vancomycin Loading Dose- Higher	37	34
IV Vancomycin Loading Dose- Lower	39	33

Primary outcome: Time to Attain Therapeutic Vancomycin Concentrations.

Time frame: Time Frame: 20 days. Median (Full Range). Unit: hours

Measure	IV Vancomycin Loading Dose- Higher n = 34	IV Vancomycin Loading Dose- Lower n = 33
Value	26.2 (7.8 to 180.8)	16.6 (4.6 to 457.6)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected systematically through renal function monitoring at baseline, 24, and 48 hours post-vancomycin. Nephrotoxicity was defined as a 0.5 mg/dL or 50% rise in serum creatinine. Vancomycin Flushing Syndrome was tracked based on symptoms like rash and pruritus. All-cause mortality was recorded through the hospital stay, up to 60 days. Data were collected prospectively according to the protocol.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IV Vancomycin Loading Dose- Higher	4 of 34 (11.8%)	0 of 34 (0%)	1 of 34
IV Vancomycin Loading Dose- Lower	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing IV vancomycin in people with Infection and Sepsis, run by CAMC Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Attain Therapeutic Vancomycin Concentrations. (time frame: Time Frame: 20 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02764359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.