Vancomycin Dosage Adjustment for MRSA Infections

Phase 4

• Conditions: Methicillin-Resistant Staphylococcus Aureus
• Interventions: Drug: Vancomycin trough concentration method; Drug: Vancomycin equation-based method

• Registration Number: NCT03412500
• Lead Sponsor: Pinyo Rattanaumpawan

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2016-06-03
• Study Start: 2016-10
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-20
• Last Update Submitted: 2018-01-20
• Study First Posted: 2018-01-26
• Last Update Posted: 2018-01-26
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin trough concentration method	Vancomycin trough concentration method	vancomycin dosage will be adjusted by the trough concentration method
Vancomycin equation-based method	Vancomycin equation-based method	vancomycin dosage will be adjusted by the equation-based method

Primary Outcome Measures

Name	Time	Method
Clinical response	End of therapy (an average of 2 weeks)	Clinical response will be evaluated at the end of therapy (EOT) by a clinician investigator. Clinical response will be classified as good clinical response, partial clinical response, poor clinical response and undetermined.

Secondary Outcome Measures

Name	Time	Method
Renal adverse event	Day 5 after vancomycin therapy	Double serum creatinine

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand