Vancomycin Dosage Adjustment for MRSA Infections

Pinyo Rattanaumpawan

Status and phase: Unknown; Phase 4

Conditions: Methicillin-Resistant Staphylococcus Aureus

Treatments: Drug: Vancomycin trough concentration method; Drug: Vancomycin equation-based method

Study type: Interventional

Funder types: Other

Identifiers

NCT03412500

101/2559(EC1)

Details and patient eligibility

About

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

Full description

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

Enrollment: 114 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Vancomycin trough concentration method

Active Comparator group

Description:

vancomycin dosage will be adjusted by the trough concentration method

Treatment:

Drug: Vancomycin trough concentration method

Vancomycin equation-based method

Experimental group

Description:

vancomycin dosage will be adjusted by the equation-based method

Treatment:

Drug: Vancomycin equation-based method