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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03412500
Other study ID # 101/2559(EC1)
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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