Effectiveness of Vancomycin Loading Therapy

NCT ID: NCT01623817

Last Updated: 2020-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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The goal of tish clinical research study is to identify that loading of vancomycin can facilitate rapid attainment of target trough serum vancomycin concentration.

Detailed Description

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The Study drug

* Vancomycin : a glycopeptide antibiotic, is the first line agent in the treatment of methicillin resistant staphylococcus aureus

Study design : Randomized controlled trials

Study Drug Administration

* If your doctor believes you are eligible, and you agree to take part in this study, you will be randomized to two treatment groups.

Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vancomcyin, maintain dose

This arm is received only maintain dose of vancomycin (15mg/kg twice a day or 1g twice a day).

Group Type NO_INTERVENTION

No interventions assigned to this group

Vancomycin loading

This group is received loading dose 30mg/kg. Subsequent doses of vancomycin are considered standard of care.

Group Type EXPERIMENTAL

Vancomycin HCL

Intervention Type DRUG

Loading dose of 30mg/kg via central or peripheral intravenous infusion during 2 or 3 hours.

Maintenance dose of vancomycin is 15mg/kg twice a day or 1g twice a day.

Interventions

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Vancomycin HCL

Loading dose of 30mg/kg via central or peripheral intravenous infusion during 2 or 3 hours.

Maintenance dose of vancomycin is 15mg/kg twice a day or 1g twice a day.

Intervention Type DRUG

Other Intervention Names

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The brand name is the Vancomycin hydrochloride. It is made by Lilly.

Eligibility Criteria

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Inclusion Criteria

* Admission to Samsung Medical Center MICU and general wards for infectious diseases and hematology division
* Patients with SIRS (systemic inflammatory response syndrome)
* Intravenous vancomycin therapy deemed necessary

Exclusion Criteria

* Age less than 20 years
* Age more than 75 years
* Current renal insufficiency defined as estimated Glomerular filtration rate \< 50mg/min/1.73 m2 by MDRD equation
* History of adverse events to vancomycin 5. Pregnant woman
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyong Ran Peck, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2011-09-067

Identifier Type: -

Identifier Source: org_study_id

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