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Trial record 27 of 528 for:    VANCOMYCIN

Vancomycin Dosage Adjustment for MRSA Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03412500
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Information provided by (Responsible Party):
Pinyo Rattanaumpawan, Siriraj Hospital

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

Condition or disease Intervention/treatment Phase
Methicillin-Resistant Staphylococcus Aureus Drug: Vancomycin equation-based method Drug: Vancomycin trough concentration method Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA

Arm Intervention/treatment
Active Comparator: Vancomycin trough concentration method
vancomycin dosage will be adjusted by the trough concentration method
Drug: Vancomycin trough concentration method
Vancomycin dosage will be adjusted according to the trough concentration method
Other Name: control arm

Experimental: Vancomycin equation-based method
vancomycin dosage will be adjusted by the equation-based method
Drug: Vancomycin equation-based method
Vancomycin dosage will be adjusted according to the equation-based method
Other Name: intervention arm

Primary Outcome Measures :
  1. Clinical response [ Time Frame: 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 :
  1. Renal adverse event [ Time Frame: Day 5 after vancomycin therapy ]
    Double serum creatinine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03412500

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Contact: pinyo rattanaumpawan, md 897778176
Contact: dawis jiravijitkul, md 6624197783

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Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Pinyo Rattanaumpawan, MD, MSCE    6624197783   
Principal Investigator: Pinyo Rattanaumpawan, MD, MSCE         
Sponsors and Collaborators
Pinyo Rattanaumpawan
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Principal Investigator: pinyo rattanaumpawan, md Mahidol University

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Responsible Party: Pinyo Rattanaumpawan, Assistant Professor, Siriraj Hospital Identifier: NCT03412500     History of Changes
Other Study ID Numbers: 101/2559(EC1)
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pinyo Rattanaumpawan, Siriraj Hospital:
Methicillin-Resistant Staphylococcus aureus
Additional relevant MeSH terms:
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Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents