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
An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Siriraj Hospital | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Pinyo Rattanaumpawan |
Thailand,
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 |
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