Vancomycin Dosage Adjustment for MRSA Infections

NCT ID: NCT03412500

Last Updated: 2018-01-26

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-09-30

Brief Summary

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An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods

Detailed Description

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An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods; a vancomycin trough concentration method and a equation-based method.

Conditions

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Methicillin-Resistant Staphylococcus Aureus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vancomycin trough concentration method

vancomycin dosage will be adjusted by the trough concentration method

Group Type ACTIVE_COMPARATOR

Vancomycin trough concentration method

Intervention Type DRUG

Vancomycin dosage will be adjusted according to the trough concentration method

Vancomycin equation-based method

vancomycin dosage will be adjusted by the equation-based method

Group Type EXPERIMENTAL

Vancomycin equation-based method

Intervention Type DRUG

Vancomycin dosage will be adjusted according to the equation-based method

Interventions

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Vancomycin equation-based method

Vancomycin dosage will be adjusted according to the equation-based method

Intervention Type DRUG

Vancomycin trough concentration method

Vancomycin dosage will be adjusted according to the trough concentration method

Intervention Type DRUG

Other Intervention Names

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intervention arm control arm

Eligibility Criteria

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Inclusion Criteria

1. Thai hospitalized patients, age\>18 years
2. Require vancomycin therapy ≥ 3 days
3. Documented MRSA infection including pneumonia, bacteremia, intra-abdominal infection or skin and soft tissue infection
4. Have been checked for serum creatinine within 48 hours and serum albumin within 7 days prior to enrollment
5. Received an appropriate loading dose of vancomycin
6. Have been treated with an appropriate maintenance dose of vancomycin
7. Willing to sign an informed consent

Exclusion Criteria

1. CrCl\< 10 ml/min or receiving renal replacement therapy
2. Pregnancy or lactation
3. Actual BW\> 90 kg
4. Serum albumin \<2 g/dl
5. Having an active cancer or receiving chemotherapy
6. Hx of vancomycin allergy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pinyo Rattanaumpawan

OTHER

Sponsor Role lead

Responsible Party

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Pinyo Rattanaumpawan

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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pinyo rattanaumpawan, md

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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pinyo rattanaumpawan, md

Role: CONTACT

897778176

dawis jiravijitkul, md

Role: CONTACT

6624197783

Facility Contacts

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Pinyo Rattanaumpawan, MD, MSCE

Role: primary

6624197783

Other Identifiers

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101/2559(EC1)

Identifier Type: -

Identifier Source: org_study_id

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