Methicillin-Resistant Staphylococcus AureusPhase 4NCT03412500
Vancomycin Dosage Adjustment for MRSA Infections
A Phase 4 study testing Vancomycin equation-based method and Vancomycin trough concentration method in people with Methicillin-Resistant Staphylococcus Aureus, run by Pinyo Rattanaumpawan at 1 site in Thailand.
Trial summary
An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus
- What is being tested?
- Vancomycin equation-based method and Vancomycin trough concentration method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2016to Sep 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thai hospitalized patients, age>18 years
- Require vancomycin therapy ≥ 3 days
- Documented MRSA infection including pneumonia, bacteremia, intra-abdominal infection or skin and soft tissue infection
- Have been checked for serum creatinine within 48 hours and serum albumin within 7 days prior to enrollment
- Received an appropriate loading dose of vancomycin
- Have been treated with an appropriate maintenance dose of vancomycin
- Willing to sign an informed consent
Who cannot join
- CrCl< 10 ml/min or receiving renal replacement therapy
- Pregnancy or lactation
- Actual BW> 90 kg
- Serum albumin <2 g/dl
- Having an active cancer or receiving chemotherapy
- Hx of vancomycin allergy
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok, 10700
Pinyo Rattanaumpawan, MD, MSCE, 6624197783, pinyo.rat@mahidol.ac.th
Pinyo Rattanaumpawan, MD, MSCE
About this study
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
Read the 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.
- Being tested
- Vancomycin equation-based method, Vancomycin trough concentration method
- Keywords
- Methicillin-Resistant Staphylococcus aureus, Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin equation-based methodDrug
Also called intervention arm
Vancomycin dosage will be adjusted according to the equation-based method
Vancomycin trough concentration methodDrug
Also called control arm
Vancomycin dosage will be adjusted according to the trough concentration method
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin trough concentration method | Active comparator | vancomycin dosage will be adjusted by the trough concentration method Receives: Drug: Vancomycin trough concentration method |
| Vancomycin equation-based method | Experimental | vancomycin dosage will be adjusted by the equation-based method Receives: Drug: Vancomycin equation-based method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of therapy (an average of 2 weeks)
Secondary outcomes (1)
Renal adverse event
Double serum creatinine
Measured: Day 5 after vancomycin therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study startOct 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin-Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pinyo Rattanaumpawan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pinyo Rattanaumpawan, Siriraj Hospital
- Investigators
- pinyo rattanaumpawan, md, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412500
- Sponsor's protocol ID
- 101/2559(EC1)
- Status last verified
- Jan 2018
- First submitted
- 3 Jun 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03412500
- Acronym / sponsor ID
- 101/2559(EC1)
- Keywords
- Methicillin-Resistant Staphylococcus aureus, Vancomycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Pinyo RattanaumpawanUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin trough concentration method | Active comparator | Drug: Vancomycin trough concentration methodvancomycin dosage will be adjusted by the trough concentration method |
| Vancomycin equation-based method | Experimental | Drug: Vancomycin equation-based methodvancomycin dosage will be adjusted by the equation-based method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Thai hospitalized patients, age>18 years
- Require vancomycin therapy ≥ 3 days
- Documented MRSA infection including pneumonia, bacteremia, intra-abdominal infection or skin and soft tissue infection
- Have been checked for serum creatinine within 48 hours and serum albumin within 7 days prior to enrollment
- Received an appropriate loading dose of vancomycin
Key exclusion criteria (6 listed)
- CrCl< 10 ml/min or receiving renal replacement therapy
- Pregnancy or lactation
- Actual BW> 90 kg
- Serum albumin <2 g/dl
- Having an active cancer or receiving chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin equation-based methodAlso: intervention armVancomycin dosage will be adjusted according to the equation-based method | Drug | Vancomycin equation-based method |
| Vancomycin trough concentration methodAlso: control armVancomycin dosage will be adjusted according to the trough concentration method | Drug | Vancomycin trough concentration method |
Primary outcome
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.
1 secondary outcome
Renal adverse event
Time frame: Day 5 after vancomycin therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: No
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Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
pinyo rattanaumpawan, md principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin equation-based method and Vancomycin trough concentration method in people with Methicillin-Resistant Staphylococcus Aureus, run by Pinyo Rattanaumpawan at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact pinyo rattanaumpawan, md (897778176, pinyo.rat@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: End of therapy (an average of 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.