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Vancomycin Dosage Adjustment for MRSA Infections

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ClinicalTrials.gov Identifier: NCT03412500
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03412500


Contacts
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Contact: pinyo rattanaumpawan, md 897778176 pinyo.rat@mahidol.ac.th
Contact: dawis jiravijitkul, md 6624197783 els1008@hotmail.com

Locations
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Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Pinyo Rattanaumpawan, MD, MSCE    6624197783    pinyo.rat@mahidol.ac.th   
Principal Investigator: Pinyo Rattanaumpawan, MD, MSCE         
Sponsors and Collaborators
Pinyo Rattanaumpawan
Investigators
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Principal Investigator: pinyo rattanaumpawan, md Mahidol University

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Responsible Party: Pinyo Rattanaumpawan, Assistant Professor, Siriraj Hospital
ClinicalTrials.gov 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
Vancomycin

Additional relevant MeSH terms:
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Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents