Vancomycin Dosage Adjustment for MRSA Infections

Methicillin-Resistant Staphylococcus Aureus Clinical Trial

Official title:

A Comparative Efficacy Study of Vancomycin Dosage Adjustment by Equation-based Method and Vancomycin Trough Concentration Method for Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03412500
• Other study ID #: 101/2559(EC1)
• Status: Recruiting
• Phase: Phase 4
• First received: June 3, 2016
• Last updated: January 20, 2018
• Start date: October 2016
• Est. completion date: September 2018

Study information

• Verified date: January 2018
• Source: Siriraj Hospital
• Contact: pinyo rattanaumpawan, md
• Phone: 897778176
• Email: pinyo.rat[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Methicillin-Resistant Staphylococcus Aureus
• Staphylococcal Infections

Intervention

Drug:
• Vancomycin equation-based method
Vancomycin dosage will be adjusted according to the equation-based method
• Vancomycin trough concentration method
Vancomycin dosage will be adjusted according to the trough concentration method

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Pinyo Rattanaumpawan

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response	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.	End of therapy (an average of 2 weeks)
Secondary	Renal adverse event	Double serum creatinine	Day 5 after vancomycin therapy